SciCheck Digest

Contrary to claims amplified by podcaster Bret Weinstein during an interview with Tucker Carlson, COVID-19 vaccines have saved millions of lives, not killed 17 million people worldwide. Weinstein also inaccurately characterized a proposed World Health Organization pandemic accord and other changes, claiming they aim to take away “personal and national sovereignty.”

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COVID-19 vaccines reduce the risk of severe COVID-19, including in children, and serious side effects are rare. Increasing evidence indicates they reduce the risk of long COVID, and they are estimated to have saved millions of lives.

Still, various people have persisted in making egregiously false claims about COVID-19 vaccines, blaming them for hundreds of thousands of deaths in the U.S., or millions of deaths globally.

According to a survey conducted by the Annenberg Public Policy Center, FactCheck.org’s parent organization, over time more and more Americans have come to incorrectly believe that the COVID-19 vaccines have killed large numbers of people. In August 2023, for example, 34% of respondents said it was probably or definitely true that the COVID-19 vaccines had killed thousands of people in the U.S., up from 22% in June 2021.

Recently, podcaster and former biology professor Bret Weinstein — known for spreading COVID-19 misinformation — spread yet another falsehood about COVID-19 vaccine deaths.

“I saw a credible estimate of something like 17 million deaths globally from this technology,” Weinstein told Tucker Carlson on a web show published Jan. 5 on Carlson’s streaming platform. Carlson, ousted as a Fox News host in April 2023, has a history of spreading misinformation on diverse topics.

Weinstein had previously told Carlson in the same interview that he was “hesitant to say what I think the toll might be because this is not my area of expertise,” referring to the purported harms from the COVID-19 vaccines. However, the false claim about COVID-19 vaccine deaths has since spread widely on social media. 

Weinstein said on X, formerly known as Twitter, that the 17 million deaths figure came from former physics professor Denis Rancourt. Fact-checkers have previously concluded that Rancourt’s conclusions are flawed because they rely on assumptions that spikes in deaths were caused by COVID-19 vaccines without showing evidence of this — and when COVID-19 itself is a clear contributor to excess deaths.

Some of the social media posts have also spread incorrect claims from the same interview about the effectiveness of COVID-19 vaccines for children. Weinstein claimed that “there’s never been any proper justification of administering it to healthy kids. … Healthy kids don’t die of COVID, and the shot doesn’t prevent you from catching or transmitting it.” COVID-19 has in fact killed some children without known underlying health conditions, not to mention the otherwise healthy children who have gotten very sick. The vaccines have been shown to reduce the risk of severe disease in children, which is the primary goal, as well as infection to some degree.

During the lengthy interview, Weinstein also spread misinformation about the World Health Organization, claiming that a pandemic accord and other changes are being discussed that would give the United Nations agency sweeping powers.

“I think it is fair to say that we are in the middle of a coup, that we are actually facing the elimination of our national and our personal sovereignty, and that that is the purpose of what is being constructed,” Weinstein said, referring to changes that he said nations could sign on to in May 2024. Weinstein’s false claims about WHO have also spread on social media.

WHO nations are working on putting together a pandemic accord, to be submitted at an annual assembly in May 2024. They will also discuss possible amendments to global health regulations. But as we have previously written, neither the amendments nor the accord, also sometimes referred to as a pandemic treaty, would affect national sovereignty.

The accord “is a generational agreement among countries to work in cooperation—not in competition—to face shared threats with a shared response,” according to an email sent to FactCheck.org by a WHO spokesperson. The spokesperson also affirmed, “No country will cede their sovereignty to WHO.”

COVID-19 Vaccines Did Not Kill 17 Million People

Claims about mass COVID-19 vaccine deaths are not plausible, given the existing data on vaccine safety, which do not show elevated mortality among vaccinated people. 

Rancourt and other researchers posted the false claim that COVID-19 vaccines caused 17 million deaths on Sep. 17 in a report by the Canada-based group Correlation Research in the Public Interest, where Rancourt is a board member and associate researcher. The report is not published in a peer-reviewed journal. 

The authors of the report gathered data from various sources on all-cause mortality in 17 countries in the Southern Hemisphere, baselessly attributing all spikes in deaths after the COVID-19 vaccines became available to the vaccines.

The authors then calculated the supposed rate of vaccine-related deaths, coming up with a bogus figure they dubbed the “vaccine-dose fatality rate.” They then used these figures to estimate global deaths from COVID-19 vaccines up through September 2023, based on the number of people vaccinated globally.

Rancourt subsequently made a similar claim on Nov. 18 at an event in Romania that also featured Weinstein as a speaker.

Rancourt’s report did not consider COVID-19 deaths. Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvania’s Perelman School of Medicine, highlighted the omission in a tweet to Rancourt the day after the report’s release.

“Why do you completely ignore the fact that the excess deaths all over the world largely cluster in spikes that happen to correspond to spikes of confirmed Covid cases and Covid-attributed deaths?” he asked. “They don’t line up with strictness of Covid mitigation, and they don’t line up with vaccination rollouts (except in places when vaccination rollouts were done during massive Covid surges).”

Since the start of the pandemic, COVID-19 is estimated to have killed more than 1.1 million Americans. Worldwide, more than 7 million COVID-19 deaths have been reported to the WHO. But during a Jan. 12 press conference, WHO’s COVID-19 technical lead Maria Van Kerkhove emphasized that that tally is an undercount. “We know that that number is certainly higher,” she said, adding that the WHO expects the true number is “at least three times higher.”

Children Benefit From COVID-19 Vaccination

Weinstein’s comments about healthy children minimized the harms of COVID-19 and potential benefits of vaccination for this group.

First, while COVID-19 is usually mild in children, the disease has been a leading cause of death in children — a group in whom deaths are generally uncommon. Between August 2021 and July 2022, COVID-19 was the eighth most common cause of death and the most common cause of death from infectious or respiratory diseases in Americans ages 19 and younger, according to a 2023 paper published in JAMA Network Open.

It is not always possible to identify which children will get very sick from COVID-19. According to data from a Centers for Disease Control and Prevention presentation, about half of hospitalized American children who died of COVID-19 between January 2022 and June 2023 did not have underlying health conditions.

There has been some legitimate debate over whether all children need to get vaccinated against COVID-19 or get updated shots. Still, there is broad consensus that the benefits outweigh the risks, and many experts and groups, including the CDC and the American Academy of Pediatrics, recommend COVID-19 vaccination for all children 6 months of age or older, unless there is a contraindication.

Second, while the vaccines’ main purpose is to prevent serious disease, they have also been shown to reduce the risk of infection in the short term.

For instance, a paper published Jan. 9 in Annals of Internal Medicine evaluated the effectiveness of the Pfizer/BioNTech vaccine, finding that a primary vaccine series reduced documented infections in children in the omicron era by around 74%. The vaccines also reduced cases of moderate or severe COVID-19 by around 76% and ICU admission by around 85%.

WHO Accord Will Not Affect National Sovereignty

Finally, Weinstein resurrected claims about the WHO pandemic accord, as well as amendments being made to global health regulations. He claimed, among other things, that the organization would be able to mandate what vaccines people would and would not receive and take away people’s rights to free speech.

For instance, Weinstein agreed when Carlson asked him if he was saying that “an international health organization could just end the first amendment in the United States” — an assertion that doesn’t have grounding in reality.

“What Weinstein is claiming is an even wilder, more extreme, version of the idea that the pandemic agreement is going to take away America’s sovereignty,” Lawrence Gostin, faculty director of Georgetown’s O’Neill Institute for National & Global Health Law, told us in an email. “These claims are entirely untrue.” Gostin, who is also director of the WHO Collaborating Center on National and Global Health Law, has been involved in drafting the new pandemic agreement.

Mandates in the accord are meant to govern international obligations, not set nations’ policies within their own borders, Gostin previously told us. This includes, for instance, obligating countries to share information on disease outbreaks with each other.

In response to Weinstein’s claims, Gostin affirmed that “the US constitution is the highest law of the land. No international treaty can override the provisions of our constitution.” He called it “false” and “legally impossible” that the WHO negotiations could “override the First Amendment” — both because the negotiations contain no provisions to do so and because any such attempts “would have no legal standing in the United States.”

He also said that the agreement would not mandate vaccinations, treatments or other public health measures. “The WHO has no power to force individuals or countries to do anything,” he said.

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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The post Tucker Carlson Video Spreads Falsehoods on COVID-19 Vaccines, WHO Accord appeared first on The Atlanta Voice.

The COVID-19 vaccines have saved millions of lives, according to multiple studies. Getting the latest vaccine provides additional protection against poor outcomes from COVID-19. Serious side effects are rare, and the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration judge that the benefits of vaccination outweigh the risks.

Despite this, Florida Surgeon General Dr. Joseph Ladapo issued a statement on Jan. 3 calling for a halt in the use of mRNA COVID-19 vaccines, made by Pfizer/BioNTech and Moderna.

Ladapo cited unsubstantiated concerns that the small amounts of residual DNA left over in the vaccines from the manufacturing process could integrate into human DNA. “If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings,” he said.

As we have written, there’s no evidence that residual DNA, which is expected and present within regulatory limits, can integrate into vaccinated people’s DNA.

(For more about residual DNA in mRNA vaccines, read our article “COVID-19 Vaccines Have Not Been Shown to Alter DNA, Cause Cancer.”)

In a Dec. 14 letter sent to Ladapo, FDA official Dr. Peter Marks said it was “quite implausible” that residual DNA could make its way into the nucleus of a cell and integrate into chromosomal DNA there. “We would like to make clear that based on a thorough assessment of the entire manufacturing process, FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines,” Marks wrote.

Residual DNA is present in a variety of vaccines. For residual DNA in the mRNA vaccines to get into a person’s DNA and have health effects would require an entire series of unlikely or implausible events. These steps would include getting around the body’s many defenses against DNA showing up in abnormal locations.

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, addressed claims about residual DNA in videos, saying that “it’s virtually impossible for these DNA fragments to do any harm. They are clinically and utterly harmless.” He told Medpage Today, “It is hard to believe that Dr. Ladapo actually issued that statement,” referring to Ladapo’s recent call for a halt in the use of the mRNA vaccines.

Ladapo, appointed by Gov. Ron DeSantis as Florida surgeon general in September 2021, has spread COVID-19 misinformation and presided over unfounded and increasingly expansive recommendations against COVID-19 vaccination in his state. In 2022, the Florida Department of Health recommended against COVID-19 vaccination for healthy children ages 5 to 17, as well as children under 5. The same year, Ladapo recommended against mRNA COVID-19 vaccination for males ages 18 to 39, based on a heavily flawed analysis of cardiac deaths by the Florida Department of Health. Ladapo later was found to have edited the study to make the vaccines appear more dangerous. 

In September 2023, he recommended against updated COVID-19 vaccines for Floridians under age 65. Then, in October, he calledrecommendations for the updated vaccines “anti-human” and said as a doctor he would be “very uncomfortable” recommending them to anyone.

Ladapo initially wrote to FDA and CDC officials about residual DNA-related concerns in a Dec. 6 letter. He cited a 2007 FDA guidance document on DNA vaccines that contain plasmids, a form of circular DNA, incorrectly claiming that the agency’s recommendations for assessing the risk of DNA from such vaccines integrating into the genome also apply to the mRNA vaccines. No DNA vaccines are yet on the market in the U.S.

The guidance is not relevant, Marks wrote in his Dec. 14 response letter. “This guidance was developed for DNA vaccines themselves, not for DNA as a contaminant in other vaccines, and is not applicable to the mRNA COVID-19 vaccines.”

Despite this clarification, Ladapo responded to the FDA letter by calling for a halt in the use of the mRNA vaccines while continuing to incorrectly claim that the FDA had gone against its own recommendations. “The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have always played it fast and loose with COVID-19 vaccine safety, but their failure to test for DNA integration with the human genome – as their own guidelines dictate – when the vaccines are known to be contaminated with foreign DNA is intolerable,” Ladapo said in a Jan. 3 post on X, the platform previously known as Twitter.

As we’ve also previously written, DNA is the primary ingredient of DNA vaccines, while it is only present in residual amounts in the mRNA vaccines. For DNA vaccines to work, there needs to be a mechanism to get the DNA into the nucleus of a cell. The mRNA vaccines, however, contain primarily mRNA, which only needs to get into the body of a cell.

Even with DNA vaccines, DNA integration is only a theoretical risk and has not been shown to be a safety problem. The FDA guidance only recommends doing integration studies in animals for DNA vaccines — in which genomic DNA in various tissues is analyzed for signs of integration — if a certain level of plasmid is shown to persist in animal tissue.

Nevertheless, the available data on the mRNA COVID-19 vaccines show no sign of genomic disruption. Marks described animal studies that “demonstrate no evidence for genotoxicity from the vaccine,” meaning that they did not see evidence that chromosomal DNA had been damaged. 

“Moreover, we now have access to global surveillance data on over one billion doses of the mRNA vaccines that have been given, and there is nothing to indicate harm to the genome, such as increased rates of cancers,” Marks said.

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

The post Faulty Science Underpins Florida Surgeon General’s Call to Halt mRNA COVID-19 Vaccination appeared first on The Atlanta Voice.

SciCheck Digest

Kate Cox petitioned to be allowed to have an abortion in Texas to “protect her life, health, and future fertility,” after receiving news that her baby was unlikely to survive, according to her court filing. A popular Instagram post misrepresented Cox’s specific case and also made misleading claims about trisomy 18, the condition affecting her pregnancy.

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Abortion is banned in Texas by multiple laws. Texas law contains exceptions for mothers with emergency medical conditions. But according to some doctors and health policy experts, it can be difficult to determine in practice whether a situation qualifies for an exception or to find a doctor or hospital administrators willing to make that judgment given the legal risks involved.

Doctors also have argued that it’s not possible or desirable to establish a formulaic definition of a medical emergency given the complexities and nuances affecting each case.

Even before June 2022, when the Supreme Court overturned Roe v. Wade, the 1973 decision that established a constitutional right to abortion, the procedure was already largely banned in Texas. The state had enacted a law in 2021 that outlawed abortions after “cardiac activity” was detected in an embryo, which occurs at about six weeks of gestation, with an exception only for a medical emergency.

On Dec. 5, Texas resident Kate Cox, her husband and her doctor petitioned for the enforcement of the state’s abortion bans to be temporarily blocked so that Cox’s doctor could legally perform an abortion. The petition argued that continuing the pregnancy, then 20 weeks along, would pose risks to Cox’s life, health and future fertility.

The petition also said that doctors had concluded, based on multiple factors, that Cox’s “baby may not survive to birth and, if so, will only live for minutes, hours, or days.”

These factors included ultrasound images that revealed serious conditions affecting the fetus. They also included a diagnosis in the fetus of full trisomy 18, also known as Edwards syndrome, in which cells throughout the body contain an extra copy of chromosome 18. The condition, which affects the development of multiple organs, is often lethal before birth, or soon after in children who are born alive.

Cox ultimately left the state of Texas to seek an abortion elsewhere, and the Texas Supreme Court ultimately concluded on Dec. 11 that Cox’s petition should not be granted, directing a local court to vacate its prior decision to the contrary. However, misinformation about the case and the survival odds for children with trisomy 18 have continued to circulate online.

A popular Instagram post made a number of misleading claims. For instance, the post stated that “90% of kids with Trisomy 18 live when given proper medical care,” while giving examples of children who defied the odds. According to studies, the median survival time for the condition among babies born alive was four to 14.5 days, and just 5.6% to 8.4% of those born alive lived to their 1st birthday.

The post also misleadingly stated that Cox “does not want to go through labor or c-section for a disabled child.” But Cox’s petition said that doctors concluded based on her specific case that her child would not survive beyond a few days at most.

Dr. Alireza Shamshirsaz, a maternal-fetal medicine specialist, told us that many women who continue a pregnancy with trisomy 18 will end up needing a cesarean section, with all the associated risks for the mother and her future pregnancies.

“If we look at this way, we are increasing the risk to the mom with having no good outcomes for baby,” Shamshirsaz said.

Shamshirsaz is a spokesperson for the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists, which wrote an amicus brief advocating that Cox be permitted to receive an abortion.

The Facts About Trisomy 18

Trisomy 18 most commonly arises when an egg cell or sometimes a sperm cell ends up with an extra copy of chromosome 18. The condition is not generally inherited, and risk increases with maternal age.

The Instagram post called trisomy 18 “a genetic condition that causes physical growth delays during fetal development.” Trisomy 18 is indeed associated with slow fetal growth, but this leaves out many other serious problems that may come with the condition. The extra genetic material also leads to issues with the development of multiple organs, including the heart, lungs and brain. 

Among trisomy 18 pregnancies that make it to 12 weeks, nearly three-quarters are expected to end in miscarriage or stillbirth, according to a study of pregnancies in England and Wales published in the American Journal of Medical Genetics. In pregnancies that make it to 24 weeks, more than half are expected to end in stillbirth.

As we’ve said, the Instagram post also made the misleading claim that most children with trisomy 18 survive “when given proper medical care.” 

While there are children with trisomy 18 who do survive beyond a year of age, this is not the outcome in the majority of cases. In one study, published in the journal of the American Academy of Pediatrics, babies with trisomy 18 who were born alive in the U.S. between the late 1960s and late 1990s died at a median 10 to 14.5 days of age. Just 5.6% to 8.4% of the babies survived until their 1st birthday. A Swiss study, published in the American Journal of Medical Genetics, found that babies with the condition who were born alive between 1964 and 2003 died at a median age of 4 days old and that just 6% were alive after a year. 

The Instagram post also did not mention the factors particular to Cox’s case. Her petition stated that ultrasounds showed multiple abnormalities affecting the pregnancy, adding that her specialist doctor told Cox and her family that “given the results of the ultrasound alone, their baby was likely to pass in utero, be stillborn, or only live for a week at most.”

Shamshirsaz said that it’s possible to stratify risks of trisomy 18 based on ultrasound. Factors such as complex heart defects, growth restriction of the fetus and other elements predict worse outcomes. He also said that full trisomy — in which all of a fetus’s cells are affected — is predictive of worse outcomes. 

Post Misrepresents Risks of Continuing Pregnancy

The Instagram post also misrepresented the risks of abortion versus continuing the pregnancy, incorrectly stating that the “claim that abortion is the safest option for Kate is false.”

“The risk of the abortion in general is less than continuing the pregnancy” at the gestational age of Cox’s pregnancy, Shamshirsaz said.

Based on medical advice, Cox concluded that dilation and evacuation abortion — a form of procedural abortion — was “the safest option for her health and her best medical option given that she wants to have more children in the future,” according to the petition. 

Shamshirsaz said that continuing a pregnancy exposes the mother to risks, including gestational diabetes and preeclampsia, a pregnancy-associated form of high blood pressure.

Cox’s petition said that she was at particularly high risk for gestational diabetes, high blood pressure and other pregnancy complications, based on a test indicating elevated glucose along with “other underlying health conditions.” 

The petition also stated that she had been to the emergency room multiple times due to severe cramping, diarrhea and fluid leaks of undetermined origin. The amicus brief said these symptoms are “associated with obstetrical complications.”

The petition said that if unable to get an abortion and if the fetus’s heart stopped beating before term, Cox would receive a labor induction. For people like Cox who have had prior C-sections, induction is associated with elevated risk of uterine rupture, which can lead to complications including removal of the uterus, excessive bleeding and death. Cox is a 31-year-old mother of two children, according to the legal filings.

If the baby reached term, the petition said, Cox would receive a C-section. Trisomy 18 comes with an increased rate of C-section, Shamshirsaz said, and Cox’s history of two prior C-sections makes the surgery even more likely.

Under any circumstances, C-sections come with risks to the mother and her future pregnancies. Risks increase with each C-section a person receives. 

Risks to subsequent pregnancies associated with repeat C-sections include uterine rupture, hysterectomy and problems with the placenta. They also include other surgical complications, such as harm to nearby organs like the bladder.

“While Ms. Cox’s life may not be imminently at risk, she is at high risk for many serious medical conditions that pose risks to her future fertility and can become suddenly and unexpectedly life-threatening,” the petition said.

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

The post Misleading Claims About Abortion and Trisomy 18 in Texas Case appeared first on The Atlanta Voice.

SciCheck Digest

A preprint on a Yale-based study described chronic symptoms self-reported after COVID-19 vaccination by 241 members of an online group. The paper, which has not been peer-reviewed, did not show how common these symptoms are in the general population, nor whether vaccinations caused them — limitations popular online posts did not make clear.

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Some people experience side effects following COVID-19 vaccination, but they are generally short-lived. There are well-established serious side effects that can occur due to COVID-19 vaccination, such as myocarditis, but these are rare. 

COVID-19 vaccination lowers the risk of severe disease and death from COVID-19. Among people who get COVID-19, those who are vaccinated may have a reduced risk of developing long COVID.

A preprint of a study posted online Nov. 10 described symptoms and other characteristics of 241 members of an online group who reported that they “thought the vaccine had injured them,” referring to COVID-19 vaccines. The authors described this group of patients as having reported “post-vaccination syndrome.” Preprints are drafts of papers posted online that have not yet been peer-reviewed or published in scientific journals. 

As we’ve written previously, a voluntary survey cannot be used to determine whether vaccines are safe, nor can it provide a representative look at people’s experiences, positive or negative, after vaccination.

“In the study, we are describing the experience of people who have a chronic syndrome that begins soon after the COVID-19 vaccination,” co-author Dr. Harlan Krumholz, a cardiologist and scientist at Yale University, told us via email. “Since we do not know the cause, we labeled it a post-vaccination syndrome. We described it like that because that’s the timing of it.” 

The participants, who were predominantly white women, reported various symptoms that they believed resulted from vaccine injury, most commonly exercise intolerance, excessive fatigue, numbness, brain fog and neuropathy. They said their symptoms started a median of three days after getting vaccinated, and they filled out the survey a median of 595 days after vaccination. 

Online posts may give the misleading impression that researchers have determined that the COVID-19 vaccines caused a new syndrome. “It’s Called ‘Post-Vaccine Syndrome’ And It’s Real!” reads the text accompanying an episode of the Jimmy Dore Show posted on Facebook by the show’s account. Jimmy Dore, who hosts the eponymous web show, has a history of making misleading or false statements about vaccination and other topics.

To be clear, the preprint assigns the label “post-vaccination syndrome” to patients’ self-reported symptoms, but it does not establish the causes of the symptoms or their prevalence among vaccinated people.

In the episode, Dore replayed a popular video previously posted on YouTube by nurse educator John Campbell, who also has a history of spreading misinformation about vaccines. Campbell opened his video by welcoming his audience and saying, “Researchers from Yale in the United States have identified a post-vaccine syndrome occurring after the COVID vaccinations.” He did not clarify that the syndrome is a collection of symptoms that were not necessarily caused by the vaccines.

Campbell went on to give AIDS as another example of a syndrome, without stating that AIDS is now a well-characterized disease with a clear cause, while “post-vaccination syndrome” is a loosely defined phenomenon whose cause or causes are unclear.

He then listed percentages of participants in the study who reported each symptom, without making clear that these numbers did not mean a high proportion of all vaccinated people would experience the symptoms.

Physician-scientists who were not involved in the study emphasized what it cannot show.

“We cannot draw conclusions about the causation of the symptoms reported in this study based on the study design,” Dr. Linda Geng, an internal medicine doctor and co-director of the Post-Acute COVID-19 Syndrome Center at Stanford University, told us in an email. “Vaccines can be life-saving and it is important that we remember their benefits for public health and the broader population as we continue to research and better understand their potential complex effects in subsets of individuals.”

“The results of the preprint would only potentially (if peer-reviewed and published) be applicable to patients who self-identify as having post-vaccination syndrome,” Dr. Alan Kwan, a cardiologist at Cedars-Sinai, told us in an email. “It should not be extrapolated to any other groups including all vaccination patients, and does not address any questions of mechanism, or causality.”

Dr. Jennifer Frontera, a neurocritical care specialist at NYU Langone Health, expressed doubt that COVID-19 vaccinations caused the symptoms described in the preprint. She described the results of her own research into neurological events after vaccination, which only showed rare links between the Johnson & Johnson vaccine and neurological conditions. “People’s symptoms are real, right? But they are probably related to something else,” she said.

Study Describes Symptoms of an Online Patient Group

The study participants were all members of an online support and research community for people affected by COVID-19, called Kindred. Krumholz co-founded a company that developed software used in the Kindred platform to help people share their medical records.

The first users of the platform were people with long COVID, Krumholz explained, and the community subsequently “was expanded to include those who were reporting a chronic syndrome that they associated with vaccination.” He added that the two groups of patients “were experiencing very similar symptoms, and the challenges that they were facing were also similar.” The LISTEN study, some of which was described in the preprint, includes both of these groups of patients. 

Survey questions prompted the participants to consider whether they had around 100 different health conditions “as a result of vaccine injury.” The most common problems attributed to vaccination — reported in half or more of the participants — were exercise intolerance, excessive fatigue, numbness, brain fog, neuropathy, insomnia, palpitations, muscle or body aches, tinnitus or humming in ears, headache, burning sensations, and dizziness.

“In this study, individuals who reported [post-vaccination syndrome] after covid-19 vaccination had low health status, high symptom burden, and high psychosocial stress despite trying many treatments,” the researchers concluded in the preprint. “There is a need for continued investigation to understand and treat this condition.”

The researchers ultimately plan to analyze not only data on symptoms and medical history, but also some blood and saliva samples.

“We are planning studies that will correlate what people are experiencing with biological signals that may indicate some underlying cause,” Krumholz said. “There are so many questions. Many of these people have been dismissed by the healthcare system. We are continuing to try to find answers.”

Definition and Causes of ‘Post-Vaccination Syndrome’ Are Unclear

Krumholz indicated that the definition of the syndrome is a work in progress. “If I were to put forth the definition, I would say that it should be a syndrome that begins within a week of the vaccination and persists for over a month. But it would be important to bring people together, including those who were affected, to develop a definition that is useful and acceptable to those affected.”

“The definition of post-vaccine syndrome is murky and not yet a formal clinical diagnosis, and it is challenging to know who may fall into this category as the scientific knowledge about post-COVID and post-vaccine effects evolves,” Geng said.

“As the authors point out, a causal link between vaccination and what is called PVS cannot be established from these data, although the reported temporal relationship between vaccination and symptom onset is suggestive,” Katherine Yih, an epidemiologist at Harvard Pilgrim Health Care Institute, told us in an email. However, she added that the lengthy period between vaccination and filling out the survey “might make recall and the timing of symptom onset uncertain.”

“I just don’t like people calling something a syndrome, post-vaccination syndrome,” Frontera said. “I feel like that’s unfortunate, because it really kind of implies causality.”

Frontera said that the symptoms described in the paper are often associated with treatable mood disorders, like depression or anxiety. She added that the group reported many preexisting health problems and social stressors, including loneliness and isolation.

Frontera referenced her own work on long-term outcomes after severe COVID-19, which involved conducting phone interviews with patients one year after hospitalization. She found that life stressors within the month prior to the phone interview were associated with prolonged COVID-19 symptoms and generally poor outcomes, such as worse depression, fatigue and sleep.

Geng said that the symptoms reported in the study “highly overlap with Long COVID.” The researchers excluded people from the study who reported that they had long COVID, Geng said, but “it is not always easy to know if the self-categorization is correct.”

There is no diagnostic test to determine if someone has long COVID, she explained, and people may get COVID-19 and be unaware of it. Around a third of the study participants reported having had COVID-19 at least once. “Depending on the extent of their medical evaluation, it is also possible there are other medical conditions that are causing these symptoms that may be missed or not yet diagnosed,” Geng said.

Vaccine Safety Studies Indicate Serious Adverse Events Are Rare

The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have not thus far found evidence of a cluster of chronic symptoms after vaccination similar to those described in the preprint.

The two agencies “are aware of reports in the Vaccine Adverse Event Reporting System (VAERS) and in the media of a wide range of long-lasting symptoms following COVID-19 vaccination (such as fatigue, headache, and difficulty concentrating),” a CDC spokesperson told us in an email, adding that these symptoms have also been reported with long COVID.

“However, to date, no unusual or unexpected patterns of long-lasting symptoms or health problems following vaccination have been linked to vaccination by COVID-19 vaccine safety monitoring systems,” the spokesperson said.

While some of the symptoms described in the preprint — such as fatigue, muscle aches and headache — overlap with symptoms commonly experienced shortly after vaccination, it is not common for these symptoms to become chronic. Data from the clinical trials for the mRNA COVID-19 vaccines indicate that common post-vaccination symptoms resolved within days on average. Safety monitoring after the COVID-19 vaccine rollout continued to indicate that vaccine side effects were generally short-lived.

Still, some researchers left open the possibility that there are yet-undetected vaccine adverse events. 

“I don’t want to impugn the surveillance systems used by the CDC but it is possible that they are missing this syndrome,” Krumholz said. “What I can say for sure is that there are many people who are suffering from a chronic syndrome that is very debilitating and began after the vaccination. It is possible that it is a coincidence – but it is important that we follow the science and discover the cause, wherever that leads us, so we can develop strategies to help these people.”

Kwan said in an interview that vaccine safety monitoring databases, such as VAERS, “are more easily set up to measure things like myocarditis and less set up to measure symptoms like fatigue or the things that were asked in this survey.” 

He co-authored a study based on medical records indicating a possible link between COVID-19 vaccination and postural orthostatic tachycardia syndrome, or POTS. POTS symptoms, such as dizziness and palpitations, overlap with those reported in the preprint. Kwan’s study found that people were more likely to be diagnosed with POTS in the 90 days after vaccination than in the 90 days before vaccination. But it also found a much more pronounced link between POTS and COVID-19, indicating that vaccination could still ultimately reduce the risk of POTS even if the link between vaccination and POTS proved to be causal.

“I personally believe there are patients out there who had adverse reactions to the vaccine and were likely injured by the vaccine and likely suffer long-term medical symptoms from it,” Kwan said. ”I think it’s unlikely that it’s a significant number of patients. It would not discourage me from encouraging people to receive their vaccinations.”

Yih co-authored a study using another vaccine safety monitoring system, Vaccine Safety Datalink, to attempt to detect unexpected COVID-19 vaccine adverse events. She said that the study detected a link between the mRNA COVID-19 vaccines and conditions such as muscle aches, headache, malaise, fatigue and palpitations — but that it’s difficult to differentiate known, common short-term side effects from long-term problems.

“Specially designed studies focusing on [post-vaccination syndrome] will be needed to more fully characterize and understand this outcome and its relationship with vaccination,” she said.

The Impact of Vaccine Information and Misinformation

The widespread dissemination of vaccine information, misinformation and disinformation can influence people’s experiences of vaccine side effects, complicating the study of people’s experiences after vaccination.

Much as the placebo effect can cause someone to experience improvements simply due to the belief they are receiving a medical intervention, a related phenomenon called the nocebo effect can cause people to experience side effects when they have only received a placebo.

Geng pointed to studies that indicate vaccine hesitancy, negative expectations or negative prior experiences with vaccination can influence the COVID-19 vaccine side effects people have, which she said “may be of interest and have some relevance to this topic at hand.”

She also cited a study exploring vaccine side effects in the placebo arms of the COVID-19 vaccine clinical trials that found that about a third of participants experienced systemic side effects after each dose. The most common side effects were headache and fatigue. 

This was a lower rate of side effects than reported in the people who got a vaccine, but nonetheless indicates a substantial nocebo response, the researchers said. They wrote that headache, fatigue, malaise and joint pain “seem to have been particularly associated with nocebo.”

On the other side of the coin, narratives about vaccines and the prevalence of anti-vaccine sentiments may also marginalize people who experience health problems following vaccination. These people may be “lumped into this general anti-vax sentiment, which I don’t think a lot of them are,” Kwan said. 

Kwan added that it’s important to acknowledge that there are people who may have “symptoms or injuries related to vaccine administration, and that there needs to be a space for them within the medical community to receive meaningful and effective care and to be heard.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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“Getting Your COVID-19 Vaccine.” CDC website. Updated 29 Sep 2023.

“Selected Adverse Events Reported after COVID-19 Vaccination.” CDC website. Updated 12 Sep 2023.

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“Long COVID or Post-COVID Conditions.” CDC website. 20 Jul 2023.

Krumholz, Harlan M. et al. “Post-Vaccination Syndrome: A Descriptive Analysis of Reported Symptoms and Patient Experiences After Covid-19 Immunization.” medRxiv.10 Nov 2023.

Yandell, Kate. “COVID-19 Vaccines Save Lives, Are Not More Lethal Than COVID-19.” FactCheck.org. 6 Nov 2023.

Krumholz, Harlan. Email to FactCheck.org. 10 Dec 2023.

The Jimmy Dore Show. “It’s Called ‘Post-Vaccine Syndrome’ And It’s Real!” Facebook. 29 Nov 2023.

Fichera, Angelo. “Video Doesn’t Show Biden Hosting ‘Black Face Skit.’” FactCheck.org. 17 Jul 2020.

Jones, Brea. “FDA-Approved ‘Electronic Pill’ Isn’t Evidence That COVID-19 Vaccine ‘Microchip’ Conspiracy Is ‘Proven.’” FactCheck.org. 26 May 2022.

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Jones, Brea. “Posts Distort Chinese Research Creating Fragment of Monkeypox Viral Genome.” FactCheck.org. 29 Jul 2022.

Dr. John Campbell. “New syndrome.” YouTube. 19 Nov 2023.

Geng, Linda. Email to FactCheck.org. 6 Dec 2023.

Kwan, Alan. Interview and email with FactCheck.org. 5 and 13 Dec 2023.

Frontera, Jennifer. Interview with FactCheck.org. 6 Dec 2023.

Frontera, Jennifer A. et al. “Neurological Events Reported after COVID‐19 Vaccines: An Analysis of Vaccine Adverse Event Reporting System.” Annals of Neurology. 2 Mar 2022.

“The LISTEN Study.” Hugo Health Kindred website. Accessed 15 Dec 2023.

Yih, Katherine. Email with FactCheck.org. 13 Dec 2023.

Frontera, Jennifer A. et al. “Life Stressors Significantly Impact Long-Term Outcomes and Post-Acute Symptoms 12-Months after COVID-19 Hospitalization.” Journal of the Neurological Sciences. 5 Nov 2022.

“Caring for People with Long COVID.” CDC website. Updated 28 Sep 2023.

Polack, Fernando P. et al. “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.” New England Journal of Medicine. 31 Dec 2020.

Baden, Lindsey R. et al. “Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.” New England Journal of Medicine. 4 Feb 2021.

Rosenblum, Hannah G. et al. “Safety of mRNA Vaccines Administered during the Initial 6 Months of the US COVID-19 Vaccination Programme: An Observational Study of Reports to the Vaccine Adverse Event Reporting System and v-Safe.” The Lancet Infectious Diseases. 7 Mar 2022.

Kwan, Alan C. et al. “Apparent Risks of Postural Orthostatic Tachycardia Syndrome Diagnoses after COVID-19 Vaccination and SARS-Cov-2 Infection.” Nature Cardiovascular Research. 12 Dec 2022.

Lovelace Jr., Berkeley. “POTS, a Debilitating Heart Condition, Is Linked to Covid and, to a Lesser Degree, Vaccines.” NBC News. 12 Dec. 2022.

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The post Yale Preprint Recorded Patient Experiences, Did Not Demonstrate Vaccines Cause New Syndrome appeared first on The Atlanta Voice.

SciCheck Digest

Data from around the world support the general safety of the COVID-19 vaccines. Some people online, however, incorrectly claim that illegally obtained data from New Zealand show the vaccines have killed 13 million people worldwide. Experts say the analysis is bogus.

Full Story

Numerous studies have found the COVID-19 vaccines are quite safe, with only a few rare serious side effects. There’s nothing to support the notion that the COVID-19 vaccines are killing large numbers of people, as some people online have claimed for years. Despite the lack of evidence, the claims remain popular, revived periodically by various pseudoscientific analyses.

Most recently, Steve Kirsch, a tech entrepreneur who has become a major source of COVID-19 vaccine misinformation, has claimed that leaked data from the New Zealand government “prove” that the vaccines have killed on average 1 person for every 1,000 doses — or when extrapolated to the entire world, about 13 million people.

“There is no possible way that this data is consistent with a safe vaccine,” Kirsch wrote in his Substack.

Experts say this is wrong. Even if the underlying data are accurate, they can’t be used to make causal claims about the vaccines, Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvania’s Perelman School of Medicine, told us. On top of that, he said, Kirsch’s methods are flawed and based on invalid assumptions — and his interpretations run counter to existing evidence.

“His methodology is extremely ad hoc and arbitrary and wrong in very specific ways,” Morris said of Kirsch.

Kirsch debuted his claims in a Nov. 30 presentation at the Massachusetts Institute of Technology, his alma mater, where he had been invited to speak by a student group. He also shared them in a Substack post, which has been shared on social media. Others have picked up his claims or circulated related claims about the New Zealand data online.

New Zealand Data Breach

A database administrator employed by Te Whatu Ora, or Health New Zealand, illegally gave Kirsch the underlying data he uses in his analysis. On Nov. 30, the worker appeared in a video with Liz Gunn, a New Zealander known for spreading conspiracy theories and her opposition to the COVID-19 vaccine, discussing the vaccine database information and making claims similar to Kirsch’s.

Soon after, the employee, a man named Barry Young, was arrested and charged for his role in the data breach, according to the New Zealand Herald. Te Whatu Ora said in a statement that there is “no evidence whatsoever that vaccination is responsible for excess mortality in New Zealand,” adding that Young has “no clinical background or expert vaccine knowledge” and that “[w]hat he is claiming is completely wrong and ill-informed and his comments demonstrate this.”

Te Whatu Ora was also granted an injunction to remove any database information that remains online to protect people’s privacy. In his Substack, Kirsch had posted the data, which he said had been anonymized, and encouraged others to download it to perform their own analyses. In some cases, people who have done so have had their file hosting accounts suspended.

Kirsch and others have tried to spin the arrest of the database administrator and subsequent removal of the data as evidence of government efforts to hide “the truth.” But Morris said Kirsch was downplaying legitimate legal issues.

“It’s a very serious thing to share identified data,” he said, adding that the information given to Kirsch “had the birth dates of the individuals, the dates they got their vaccines, the dates they died, which could uniquely identify every single person.”

Kirsch has argued that his sharing of the data is not a problem because it was anonymized, but it’s not necessarily clear yet whether the data contains any identifying information. Morris said he would have performed and presented his own analysis of the data, but did not feel comfortable doing so because of potential legal and privacy concerns.

Plausibility Check

There are multiple problems with Kirsch’s analysis that Morris and others have noted, as we’ll explain in more detail below. And tellingly, even many people who have spread misinformation about the COVID-19 vaccines before and believe the vaccines are killing people have pushed back on Kirsch’s claims.

But Morris also suggested looking at excess death graphs for New Zealand and other countries just to see whether Kirsch’s claims pass a basic sniff test — and they do not.

In much of the world, spikes in excess deaths closely correspond to when countries experienced COVID-19 deaths. There is no evidence that millions of people died from the vaccines.

New Zealand is a little different in that during much of the pandemic, the country actually had a deficit of deaths, likely due to the mitigation measures the island took and the success the nation had in keeping the coronavirus out. Those measures may have also reduced flu deaths and other kinds of deaths.

But there, too, the only real period of excess deaths occurs during the two waves of COVID-19 New Zealand experienced in March and August 2022, a year or so after vaccination began. Some excess deaths in 2022 could also be a kind of catch-up, Morris said, from older people who avoided dying in 2020 and 2021. 

Regardless, the pattern is clear, Morris said, and part of what happened in 2022 in New Zealand was a return to a baseline level of death after a couple of years of fewer deaths.

“What he’s saying is implausible,” Morris said of Kirsch.

Flawed Analysis with Incorrect Assumptions

According to his description, Kirsch’s analysis consists of what he calls a “time-series cohort analysis” of “record-level data” from 4 million out of the 12 million COVID-19 vaccine doses given in New Zealand. These doses, he says, were part of a pay-per-dose program in the country, which he claims were randomly administered.

Kirsch uses the data to plot death rates from any cause over time since vaccination, claiming that if the vaccine is safe, the graph should level off and be flat or decline three weeks after vaccination. If it’s not, he says, any increase reflects deaths caused by the vaccine. Using this flawed logic, he then calculates a death rate for all ages of 1 death per 1,000 doses, which he applies globally to arrive at his 13 million estimate of the number of people killed by the vaccines, and an estimate of 675,000 for the U.S.

There are numerous problems with this approach. To start, Morris said many of Kirsch’s assumptions are simply not true. 

“There’s nothing in the literature that says, oh, these plots should be completely flat. And if they’re not flat, the only explanation can be that the vaccine is causing death,” he said. “There’s no such thing.”

In theory, Morris said, the curve for a “safe vaccine” would be flat if there’s a constant death rate that never varies throughout the year, and if the decision to get vaccinated or additional doses is completely random. But that’s not the situation with real data. So in fact, Morris said, there are many reasons why a curve might increase, even if a vaccine is not killing people.

Susan Oliver, an Australian scientist who corrects misinformation, similarly explained in a YouTube video critiquing Kirsch’s claims that such curves are not expected to be flat for seasonal vaccines. “The reason for this is because deaths [due to any reason] don’t occur uniformly throughout the year,” she said. “They follow a seasonal trend with higher deaths in the winter months.”

The same could be true during a pandemic if many people are vaccinated around the same time, and then COVID-19 restrictions are lifted and a COVID-19 wave hits, as occurred in New Zealand. Or, as also happened in New Zealand, an abnormally low mortality rate rebounded to a normal level after a period of intense COVID-19 restrictions.

Kirsch has simply claimed that the vaccination records he has represent a random sample of the 12 million doses given in New Zealand. But he provides no evidence that this is true, instead arguing that others have to prove him wrong, incorrectly reversing the burden of proof. 

There is little public information about the pay-per-dose program, and Te Whatu Ora told us it could not provide further comment given the ongoing investigation and injunctions. However, it appears the pay-per-dose system was for reimbursing providers such as primary care practices, which would have been separate from mass vaccination clinics, for example. It is hardly clear that the populations served by both groups would be identical. And in any case, there remain important differences between the populations that get a different number of doses.

Additionally, while Kirsch is aware of what’s called the healthy vaccinee effect — a phenomenon in which, especially at first, vaccinated people will have an artificially lower rate of death than the overall population because very sick people would not be getting vaccinated — Morris said Kirsch arbitrarily decided that it ends after exactly three weeks. There’s no basis for that, he said.

Kirsch then uses the rate of death at three weeks as the baseline for death and counts all deaths above that as excess deaths caused by the vaccines. Again, Morris said it’s invalid to just assume that all excess deaths would be vaccine-caused — but also, the baseline may be completely incorrect.

Morris suspects that this is the case, noting that while Kirsch’s main analysis misleadingly focuses on all ages and all doses, when the rising death rates only exist for older people, one would really need to break the data down by age and by dose, and then use actuarial data for each age group to get some idea of an accurate baseline. The baseline Kirsch uses is much too low, he said.

The entire “increase” in deaths could simply be a recovery back to the actual baseline. “He hasn’t ruled that out at all,” Morris said of Kirsch.

This gets at another fundamental problem with Kirsch’s analysis: the lack of an unvaccinated group. Kirsch claims this isn’t needed for his type of analysis, but as Morris told us, Kirsch has no idea how the death rates in vaccinated or unvaccinated people compare.

“When you don’t even have the unvaccinated, then you have no calibration point because it’s possible that whatever you’re looking at in the vaccinated, it’s possible that their death rate is lower than the unvaccinated across the board,” Morris said. “So if that’s the case, how can you argue that the vaccine is killing people on the basis of this data?”

Indeed, while Kirsch presents his analysis as iron-clad proof that the vaccines have killed millions of people, it’s incorrect to even say that this data could provide that degree of certainty.

“The data that he got, even if it’s fully legitimate and accurate, cannot be used to answer the question that he wants to answer about causal effects of vaccines on death,” Morris said.

Kirsch also hypes the data, misleadingly claiming that “[n]o State or country has ever released record-level public health data on any vaccine” and casting his analysis as special.

Morris said that in fact, while no one else uses the term “record-level data,” such information has been used in numerous COVID-19 vaccination studies around the world, which have turned up no evidence of mass vaccine-related death. 

But unlike in Kirsch’s case, those researchers have a legal right to use the data, and the raw data are not shared because of privacy reasons. In addition, Morris said, that data usually include information on confounders, or other variables that might be associated with an outcome of interest such as death — precisely the data that would help make a causal connection, but something that is lacking in Kirsch’s dataset.

Clarification, Dec. 15: We updated the story to clarify Morris’ comment about not performing his own analysis of the New Zealand data.

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

Sources

Morris, Jeffrey S. Director, Biostatistics Division and Professor of Public Health and Preventative Medicine at the University of Pennsylvania, Perelman School of Medicine. Zoom interview with FactCheck.org. 8 Dec 2023.

“UPDATE: Unauthorised data breach and attempt to spread misinformation.” Statement. Te Whatu Ora/Health New Zealand. 8 Dec 2023.

Plummer, Benjamin and Lincoln Tan. “Police arrest man in connection with alleged Te Whatu Ora mass privacy breach of Covid vaccination data.” New Zealand Herald. 3 Dec 2023.

Griffiths, Ethan. “Te Whatu Ora employee charged with Covid-19 vaccination data breach granted bail.” New Zealand Herald. 3 Dec 2023.

“Reminder of vaccine safety and effectiveness following release of misinformation.” Statement. Te Whatu Ora/Health New Zealand. 1 Dec 2023.

“Investigation ongoing into release of data and spread of misinformation.” Statement. Te Whatu Ora/Health New Zealand. 3 Dec 2023.

Gorski, David. “Steve Kirsch’s ‘mother of all revelations’ about the ‘deadliness’ of COVID-19 vaccines goes poof.” Science-Based Medicine. 4 Dec 2023.

“Steve Kirsch’s claim that New Zealand data shows COVID-19 vaccines killed millions is based on a flawed analysis.” Health Feedback. 8 Dec 2023.

“First batch of COVID-19 vaccine arrives in NZ.” Press release. New Zealand government. 15 Feb 2021.

Back to the Science. “Record level stupidity – Steve Kirsch and the New Zealand data.” YouTube video. 13 Dec 2023.

Te Whatu Ora/Health New Zealand. Email to FactCheck.org. 12 Dec 2023.

“Briefing on the Government’s response to COVID-19.” New Zealand Parliament. 26 Aug 2021.

The post Analysis reveals flawed methodology behind misinformation on COVID-19 vaccine deaths appeared first on The Atlanta Voice.

SciCheck Digest

People who receive some vaccines that use live weakened viruses to stimulate a strong and lasting immune response sometimes release small amounts of those viruses outside of their bodies. That’s expected, and it doesn’t mean that they put vulnerable populations in “harm’s way,” as a post misleadingly suggests.

Full Story

Getting vaccinated is the safest way to get protection against certain diseases that can be dangerous and sometimes deadly. Multiple vaccines are recommended and especially important in children, the elderly and people with weakened immune systems and their close contacts, given that these groups are more susceptible to, and could suffer from complications from, preventable diseases. 

Different types of vaccines work in different ways, but they all prompt the body to mount an immune response against a specific pathogen, which provides protection against a particular disease without a person having to get sick. Live attenuated vaccines contain a small amount of live virus that has been weakened. The live attenuated vaccines routinely recommended in the U.S. are the measles, mumps and rubella, or MMR vaccine; the varicella, or chickenpox, vaccine; the rotavirus vaccine; and the intranasal influenza vaccine. 

With live attenuated vaccines, since the virus is weakened but not inactivated or “killed,” the virus can still replicate in the body, although much less so than a natural virus. This creates very strong and long-lasting immune protection, similar to the immunity stimulated by natural infection. It also means the weakened virus could be released or discharged outside the body, and, if there is a large amount of it, potentially transmitted to others. But that doesn’t mean that the vaccines are harmful or shouldn’t be used.

“When a pathogen replicates in the body, it can be shed in respiratory secretions or in stool. We call that shedding,” Benjamin Lopman, professor of epidemiology and environmental health at Emory University’s Rollins School of Public Health, told us in an email. “In some instances, it is possible for shed LAVs to be transmitted to other persons. However, since LAVs are safe, this generally does not present a problem,” he said, referring to live attenuated vaccines.

According to the Centers for Disease Control and Prevention, live attenuated vaccines “usually do not cause disease such as that caused by the wild form of the organism. When a live, attenuated vaccine does cause disease, it is usually much milder than the natural disease and is considered an adverse reaction to the vaccine.”

But a post published on Instagram gives the misleading impression that live attenuated vaccines are not safe and put vulnerable groups “in harm’s way.”

“Aren’t  supposed to protect the vulnerable people from disease?  can actually spread disease. Maybe’ you’ve heard of it, it’s known as shedding,” reads the caption of the Instagram post, which includes six slides about shedding and vaccines. 

The post continues by quoting a line from an article on live attenuated vaccines published in 2010 in Nature Biotechnology.

“Because LAVs (live attenuated viruses) are shed from , they sometimes present a risk to un- individuals with impaired immunity,” reads the post, which incorrectly says the article was published by the National Institutes of Health.

The post continues: “So young children, pregnant women, immune compromised, the elderly…..that group of individuals we are told as those who choose not the , that we are putting in harm’s way.” 

Raul Andino-Pavlovsky, professor of microbiology and immunology at the University of California, San Francisco, and one of the authors of the article cited in the Instagram post, told us in an email that not all live attenuated vaccines can be transmitted. “Most LAVs are not transmissible,” he wrote.

Moreover, he said, “it is crucial to emphasize that LAV viruses are attenuated in their pathogenicity. This means they replicate less effectively and do not infect tissues and organs where they cause disease.”

In other words, since the weakened virus reproduces less effectively than the naturally occurring virus would, less virus is shed, which makes it harder for someone else to get infected. And again, since the virus has been debilitated, it’s not able to produce symptoms in most people. 

For this reason, in most cases, even people living with someone who is immunocompromised can — and in fact should — be vaccinated, including with live attenuated vaccines. 

“Children in the homes of immune-compromised people can safely receive all routinely recommended vaccines. Adults in the home or in close contact with immune-compromised individuals should also be up to date on all routinely recommended vaccines, so they do not inadvertently expose the vulnerable person to vaccine-preventable diseases,” as the Children’s Hospital of Philadelphia Vaccine Education Center explains.

“Being a household contact of a pregnant woman or immunosuppressed person is usually not a contraindication to vaccination,” the CDC’s Pink Book, which is the agency’s guide to vaccines and vaccine-preventable diseases, says. “In fact, it is critical that healthy household contacts of pregnant women and immunosuppressed persons be vaccinated. Vaccination of healthy contacts reduces the chance that pregnant women and immunosuppressed persons will be exposed to vaccine-preventable diseases.”

Of the vaccines given in the U.S., the only vaccine that should not be given to people who are in close contact with immunocompromised people is the smallpox vaccine, which is only given in select circumstances. There are also some additional precautions that can be taken in a few other instances, as we’ll explain below. But the general notion that people should avoid vaccination because of shedding concerns is incorrect.

Some Vaccine Shedding Is Expected

The fact that some live attenuated vaccines shed is generally not cause for alarm.

Shedding is common after receiving a live attenuated influenza vaccine, according to the CDC, especially among younger people. Shedding is not the same as transmission, since transmission requires a larger amount of virus. Transmission of shed influenza vaccine viruses from vaccinated to unvaccinated people has been documented, according to the agency, “but has not been reported to be associated with serious illness,” the CDC explains. Close contacts of immunocompromised people can receive the live attenuated influenza vaccine, unless the person with immunocompetence is in a protective environment, according to the agency.

In a 2006 clinical study among 197 children, ages 9 months to 3 years, who received a vaccine or placebo, 80% of the vaccine recipients shed at least one vaccine strain, and one transmission was documented. The probability of transmission was calculated at 0.58%. “No clinically significant illness occurred among children who received vaccine or placebo or in the child to whom the vaccine virus was transmitted,” according to the study.

With the chickenpox, or varicella, vaccine, the manufacturer says transmission of the vaccine virus “may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts.” It adds that according to findings from a placebo-controlled trial with 416 placebo recipients who were household contacts of 445 vaccine recipients, “if vaccine virus transmission occurred, it did so at a very low rate and possibly without recognizable clinical disease in contacts.” A person who gets vaccinated against chickenpox and lives with someone who is immunocompromised does not need to take any extra precautions, the CDC says, unless they develop a rash. If that happens, the vaccinated person should stay away from the vulnerable person until the rash resolves.

Similarly, shedding and transmission have been detected with the rotavirus vaccine. According to the manufacturer, in the safety and efficacy trial, shedding in the stool was detected in 32 of 360 vaccine recipients after dose one, but in none of 249 vaccine recipients after dose two. Transmission was not evaluated in phase 3 studies, but has been observed.

For this reason, the CDC recommends that everyone in a household with an immunocompromised person take particular care to wash their hands after changing the diaper of an infant who received rotavirus vaccine. But again, this is not a good reason to not vaccinate a child in the first place.

As a 2008 review on viral shedding from rotavirus vaccines put it, “[s]ince the risk of vaccine transmission and subsequent vaccine-derived disease with the current vaccines is much less than the risk of wildtype rotavirus disease in immunocompromised contacts, vaccination should be encouraged.”

The main live vaccine for which viral shedding can be a real problem is the oral polio vaccine. The vaccine hasn’t been used in the U.S. since 2000, but other countries use it because it can prevent onward transmission of polio and is better for eradication efforts. Most of the time, viral shedding of the weakened vaccine virus is not a concern — and it can even be beneficial because it provides contact immunity or indirect vaccination, as experts told us for a previous story.

But sometimes the vaccine virus can change back into a more dangerous virus that can cause paralysis. This happens when the virus accumulates mutations after circulating for a long time in populations with low rates of vaccination or in immunocompromised people. This strain of vaccine-derived poliovirus can shed and infect others, putting unvaccinated people at risk of getting polio.

This only stresses the importance of vaccination among vulnerable groups. Polio was eliminated in the U.S. in 1979 thanks to widespread vaccination. And as part of the efforts to eradicate polio globally, scientists developed a new version of the oral polio vaccine, first rolled out in 2021, that is less likely to revert and cause vaccine-derived poliovirus outbreaks.

Live Attenuated Vaccine Contraindications

Although live attenuated vaccines are generally safe, they are contraindicated for certain groups and in certain instances. 

They are not recommended for pregnant people due to a “theoretical risk of virus transmission to the fetus,” according to the CDC.

The CDC also says that live vaccines usually shouldn’t be given to severely immunocompromised people, such as people with leukemia, or people taking drugs that can cause severe immunosuppression, such as someone undergoing treatment for cancer. This is because these individuals may be unable to limit the replication of the weakened vaccine virus, which can lead to severe illness or death. Still, some immunocompromised people may receive some live attenuated vaccines safely, so patients should consult their doctors, since recommendations vary case by case. 

Most live attenuated vaccines “can safely be given to vulnerable people with some exceptions,” Lopman, from Emory University, told us.  

“Live attenuated vaccines have been used for as long as vaccines have existed. They are widely used globally and are generally safe,” Lopman said. “Severe reactions are extremely rare.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

The post Vaccine Shedding Is Expected With Some Vaccines and Generally Not Harmful, Contrary to Post appeared first on The Atlanta Voice.

Five Republican senators have penned a letter to President Joe Biden urging him to ban travel to the U.S. from China because of a surge in “mystery” respiratory illnesses among children. But the letter selectively cites outdated information from the World Health Organization, and experts say the illnesses are likely due to known viruses and bacteria and aren’t unexpected.

Since at least mid-October, there has been an uptick in respiratory illnesses in children in northern China. Initially there was some concern about the situation, based on descriptions in local media on Nov. 21 of possible clusters of undiagnosed pneumonia in kids. But further investigation suggests that the illnesses are a result of known pathogens, including Mycoplasma pneumoniae, a pneumonia-causing bacteria, as well as respiratory syncytial virus, or RSV, adenovirus and influenza virus.

“Some of these increases are earlier in the season than historically experienced, but not unexpected given the lifting of COVID-19 restrictions [in China], as similarly experienced in other countries,” a Nov. 23 update from the WHO reads, specifically advising against travel restrictions, as the WHO typically does.

Last year, American kids were hit hard by an earlier-than-usual surge of RSV, likely due to an “immunity gap” phenomenon. Public health precautions during the COVID-19 pandemic reduced exposure to a variety of pathogens, leaving more people without immunity and susceptible to these diseases, allowing for a burst of cases in the population at the same time. China only lifted its “zero-COVID” policy, which was far more extreme than anything implemented in the U.S., in late 2022.

Despite evidence indicating that the surge in pediatric illnesses is largely expected and not suggestive of a new pathogen, several Republicans have pushed the notion that the illnesses in China are a threat to the U.S. — and have called for a ban on travel from that country.

In a Dec. 1 letter, Sens. Marco Rubio and Rick Scott of Florida, J.D. Vance of Ohio, Tommy Tuberville of Alabama, and Mike Braun of Indiana claimed that “the world faces another unknown pathogen emanating from the PRC that could spread to other countries, including the United States” — and that the prudent response is to halt travel from China.

“A ban on travel now could save our country from death, lockdowns, mandates, and further outbreaks later,” they wrote.

The quintet misleadingly referred to “the dangers posed by this new illness” — even though the evidence at this time does not point to a novel pathogen. 

On X, the platform formerly known as Twitter, Rubio and Scott repeated this incorrect impression. 

“A new mysterious respiratory illness is emerging in China and the mistakes from COVID-19 cannot be repeated,” Rubio said in a Dec. 1 tweet, adding that he had sent a letter to Biden “urging him to impose a travel ban on China until we gain further knowledge on this virus.” 

In a subsequent tweet, Rubio again referred to a “‘mystery pneumonia’ outbreak.” The next day, Scott similarly wrote on X that “the U.S. must do everything possible to prevent this new illness from reaching American shores.”

Not Very ‘Mysterious’

As we said, a review of the available evidence does not suggest that the pediatric illnesses in China are due to a new illness. Instead, the WHO and other independent experts say it makes sense that what’s happening in China is a resurgence of multiple known respiratory pathogens as a result of normal seasonal increases combined with the lifting of pandemic restrictions.

In a Nov. 24 interview with STAT, Maria Van Kerkhove, director of the WHO’s epidemic and pandemic preparedness and prevention unit, said that the evidence provided by China, some of which the WHO could cross-check, is consistent with an “immunity gap” explanation.

“This is not an indication of a novel pathogen,” she said. “This is expected. This is what most countries dealt with a year or two ago.”

Chinese health officials said that none of the patients had unusual presentations or were unable to be diagnosed, Van Kerkhove said, adding that the data suggest the uptick in disease “is an overall increased wave, not discrete clusters.”

On Nov. 30, testifying before a House subcommittee, the newly installed Centers for Disease Control and Prevention director, Dr. Mandy Cohen, said the agency did not think the illnesses were due to a novel pathogen.

Dr. Scott Gottlieb, a Food and Drug Administration commissioner under former President Donald Trump, similarly told CBS News on Dec. 3 that “it does appear to be more usual strains of illness. So, there’s no reason to believe that there’s something novel spreading there.”

The CDC told us in an email that the agency is in contact with its own staff in China, as well as local health authorities and global health partners, and current information supports the conclusion that the respiratory illnesses are “NOT due to a new or novel virus or illness.”

In China this year, the CDC said, mycoplasma bacterial infections were on the rise at least as early as September, but in November flu replaced mycoplasma as the primary cause of pediatric respiratory illnesses. 

Mycoplasma infections are known to be cyclical, spiking in frequency every three to seven years. China has seen upticks in 2011, 2015 and 2019, the agency said, so a surge in 2023 is not surprising.

Mycoplasma infections tend to be longer-lasting but less severe than other forms of pneumonia. Cases are most common in school-aged children and young adults and can usually be easily treated with antibiotics, although antibiotic resistance can be a problem in some parts of the world, including China.

“I don’t think it’s accurate to describe the rise in pediatric illnesses in China as mysterious,” Jennifer Nuzzo, an epidemiologist and director of the Pandemic Center at Brown University School of Public Health, told us in an email.

When news first broke of the situation in China, the word “mysterious” was used in some reporting. On Nov. 21, ProMed, an emerging disease alert system, flagged a local news story describing children’s hospitals in Beijing and Liaoning, a province bordering North Korea, being overrun with pneumonia cases. The ProMed alert said the news report “suggests a widespread outbreak of an undiagnosed respiratory illness” in children.

This garnered international attention, including from the WHO, which issued a statement on Nov. 22 asking for more information from China. Chinese officials met with the WHO the next day, which is also when the WHO released its updated assessment. 

But even before WHO’s update, experts noted that it wouldn’t make sense that a novel pathogen would only affect children — and that the most likely explanation is a resurgence of known illnesses after children in China avoided those germs for about three years.

The Republican letter, notably, selectively draws on statements the WHO made in its earlier Nov. 22 statement, writing that the organization “says it is unclear if the disease is due to an overall increase in respiratory infections or separate events” and that it has “requested that the CCP share ‘detailed information’ about the mystery illness.” 

This omits the fact that by Nov. 23 — a full week before the letter was issued — China did provide more information, and that WHO officials and others see no evidence of a new pathogen being involved.

No Connection to Ohio Pediatric Pneumonia Outbreak

Separately, some people online have been erroneously linking an outbreak of pediatric pneumonia in Ohio to the situation in China. 

“The ‘Mystery pneumonia’ affecting kids and ripping through China and parts of Europe, is reportedly now in America,” conservative commentator Charlie Kirk posted on X on Nov. 30. “142 child cases of ‘white lung syndrome’ have now been recorded in Warren County, Ohio since August, meaning if true, it’s been here for months.”

“Mystery outbreak of pneumonia has hit several parts of China, and now Ohio is the first American location to report an outbreak of the illness,” reads another misleading post on Instagram.

The circumstances in Ohio and China are similar, but there’s nothing to suggest that they’re related.

Health officials in Warren County, located in the southwestern part of the state, explained on Nov. 29 that while they’ve seen “an extremely high number of pediatric pneumonia cases” this fall, they “do not think this is a novel/new respiratory disease but rather a large uptick in the number of pneumonia cases normally seen at one time.”

“There has been zero evidence of this outbreak being connected to other outbreaks, either statewide, nationally or internationally,” officials added in another statement on Nov. 30.

“We don’t have any evidence to suggest this is anything but routine standard winter bugs causing pneumonia in higher rates in kids,” Dr. Clint Koenig, the medical director at the Warren County Health Department, told the Washington Post. 

The number of pneumonia cases in the county has been unusually high — 145 since August, as of the end of November, meeting the Ohio Department of Health’s definition of an outbreak. But the cases have not been more severe than usual, and no children have died. Moreover, contrary to suggestions on social media, the cases are not due to a single mysterious illness. Multiple different known pathogens, including adenovirus and mycoplasma and pneumococcus bacteria, have been recovered, officials said.

As of Dec. 1, according to CDC data, rates of pneumonia in children across the entire U.S. are not abnormally high for the season. 

Many news reports and social media posts have used the “white lung” moniker to describe the pneumonia cases, but this is not a medical term and could incorrectly suggest increased severity or a novel disease.

Pneumonia can show up on a chest X-ray as white patches, reflecting the infection’s inflammation or fluid buildup. Normally, since lungs are filled with air, they don’t block much radiation and will appear dark. But a fully white lung X-ray is rare — sometimes called lung “white out” in the medical literature — and would indicate the lung has collapsed or has another serious problem.

“This white lung syndrome is not a thing as it relates to any of our cases,” Koenig told the Washington Post. “There’s no data to support the current colloquial use of that phrase with what we are seeing. It’s inappropriate. It’s inaccurate.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

The post Respiratory Illnesses in Children in China Not So ‘Mysterious’ appeared first on The Atlanta Voice.

SciCheck Digest

The mRNA COVID-19 vaccines — like many other vaccines — can contain small amounts of DNA left over from the manufacturing process. There’s no evidence this residual DNA causes “turbo cancer,” or very aggressive cancer. Nor did Moderna admit that “mRNA Jabs Cause Turbo-Cancer,” contrary to an online article that misconstrues a line from a patent application.

Full Story

Vaccines can contain trace amounts of materials left over from their manufacturing process. One of these materials is DNA, which can remain in both mRNA vaccines and a variety of older vaccines. This DNA is expected and considered safe, and there are purification and quality control steps meant to ensure it is present within regulatory limits.

We have covered unsubstantiated claims that residual DNA in mRNA COVID-19 vaccines is considered “adulteration” or integrates into people’s DNA and causes cancer. Representatives from regulatory agencies and various academic experts told us there isn’t reason to believe the small amounts of residual DNA in the mRNA vaccines would integrate into a person’s cellular DNA and cause cancer. And legal experts told us that the residual DNA would not be considered adulteration.

(For more about residual DNA in mRNA vaccines, read our article “COVID-19 Vaccines Have Not Been Shown to Alter DNA, Cause Cancer.”)

In a twist on these claims, recent social media posts shared a headline falsely stating that “Moderna Admits mRNA Jabs Cause Turbo-Cancer” and referencing the residual DNA found in vaccine vials. The headline is from an article published by the People’s Voice, a website with a history of spreading misinformation and publishing false headlines.

As we also have written previously, there isn’t reason to believe the mRNA vaccines cause very aggressive cancer, or “turbo cancer.”

The new false claim, that Moderna has admitted the mRNA vaccines cause turbo cancer, stems from misleading statements made by Dr. Robert Malone, who has spread COVID-19 misinformation in the past. Malone made his remarks during a Nov. 13 event held and livestreamed by Rep. Marjorie Taylor Greene. 

Malone referred to a short section in a Moderna patent application, published in 2019. The patent application is related to RNA vaccines, but the comments Malone highlighted are about DNA vaccines, which remain experimental in the U.S.

In its description of DNA vaccines, the Moderna patent application mentioned some theoretical cancer-related concerns as an example of a drawback of the technology: “With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.” 

Insertional mutagenesis is a phenomenon in which foreign DNA integrates into a genome, causing changes. The concern the patent application references is that the DNA could integrate in precisely the wrong place in a cell’s DNA and turn on a gene that could contribute to cancer or turn off a gene that helps protect cells from becoming cancerous.

“FDA says they’re not aware of any concerns, but Moderna in its own patent lays out exactly the same concerns that exist about DNA and insertional mutagenesis and genotoxicity,” Malone said. 

But the concerns mentioned in the patent application were about vaccines using DNA as their main ingredient, not residual DNA left over in other types of vaccines. DNA vaccines rely on getting DNA into the nucleus of a cell, where it is transcribed into mRNA, which is used to make protein. The messenger RNA, or mRNA, vaccines work by introducing mRNA into the body of a cell, where it serves as instructions for making protein. 

With residual DNA, scientists from the U.S. Food and Drug Administration have written that they consider the primary cancer-related concern to be the introduction of DNA encoding an activated cancer-causing gene. There is no residual DNA encoding cancer-causing genes in the mRNA COVID-19 vaccines.

The patent application also makes clear that even for DNA vaccines, the concern is theoretical. What the line quoted from the patent application does not spell out is that this “potential” concern has not been demonstrated to be a real safety problem, even for DNA vaccines.

In a 2020 review paper on mRNA vaccines, FDA scientists nodded to the theoretical concerns about insertional mutagenesis from DNA vaccines, while making clear they did not consider this risk to have been borne out.

In listing advantages of mRNA vaccines over DNA vaccines, they referred to the absence of the “perceived” risk of DNA integrating into a person’s own DNA. They went on to explain that this was a concern with DNA vaccines in the past, but experiments have shown that the rate of integration was low, “thus lessening the concern for integration.”

In a response sent to us for our prior article on residual DNA in the mRNA COVID-19 vaccines, an FDA spokesperson did in fact make reference to past concerns about DNA integration and cancer, while expressing confidence in the mRNA vaccines.

The FDA email said that “with regard to the mRNA vaccines, while concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion that the minute amounts of residual DNA do not cause cancer or changes to a person’s genetic code.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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Yandell, Kate. “COVID-19 Vaccines Have Not Been Shown to Alter DNA, Cause Cancer.” FactCheck.org. 26 Oct. 2023.

Amanda (@the_barefoot_truther). “Imagine, cancer from a concoction of poison that was never intended to be injected into your body 🤦🏻‍♀️…” Instagram. 21 Nov 2023.

The Unity Project (@theunityprojectonline and @theunityproject2.0). “Pay attention, the truth is being exposed. Comment the word “truth” if you’d like to read the full article. …” Instagram. 21 Nov 2023.

Adl-Tabatabai, Sean. “Moderna Admits mRNA Jabs Cause Turbo-Cancer; Investigators Find Billions of DNA Fragments in Vials.” The People’s Voice. 18 Nov 2023.

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The post Moderna patent application does not admit mRNA vaccines cause turbo-cancer appeared first on The Atlanta Voice.

SciCheck Digest

A recent federal report shows a 3% increase in the U.S. infant mortality rate between 2021 and 2022, which is the first statistically significant rise in 20 years. The cause of the uptick is unknown, but there’s no evidence that it’s due to COVID-19 vaccination, as some social media posts baselessly suggest.

Full Story

A recent report from the Centers for Disease Control and Prevention showed that in 2022, 5.6 infants out of every 1,000 live births died before they turned 1 in the U.S., a 3% increase over 2021. This returns the infant mortality rate, which has steadily fallen over the decades, to the 2019 level.

The data in the report, which compared birth and death records collected through the National Vital Statistics System, are provisional. The last time the infant mortality rate had a statistically significant year-to-year increase was from 2001 to 2002, when it also rose by 3%.

The rise in 2022 was driven by significant increases in mortality for several categories measured in the report — in infants born to women ages 25 to 29; in infants born in four states (Georgia, Iowa, Missouri and Texas); in infants of American Indian and Alaska Native and white women; in infants born preterm; and in male babies. Mortality rates also increased in cases of maternal complications and bacterial sepsis, two of the 10 leading causes of infant death.

But Danielle Ely, a co-author of the study and a health statistician at the CDC’s National Center for Health Statistics, told us that other than the increase in infant mortality itself, the data didn’t show “any specific trends or narratives to note at this point.”

“This could potentially be a single year increase and in 2023 the rate could remain at this level or decline, however the rate could also increase again in 2023. We will not know for sure until we have complete provisional data for 2023,” she said in an email.

But some social media users took advantage of the uncertainty to push their own narratives.

“So the CDC is reporting the largest increase in infant mortality in the past 20 years. And apparently experts are baffled. You’re baffled? Really? Gosh it’s so weird that experts are baffled but those of us who have been non-compliant for the past three years know exactly why this has happened,” a woman suggestively said in a popular Nov. 8 Instagram post. 

Another viral post published on Facebook the same day shows a collage of CNN headlines with boxes and lines linking encouraging news about COVID-19 vaccination in pregnant women to a last headline about the rise in infant mortality. “I wonder when we’ll see the actual data in its totality,” the caption reads. 

There is no evidence that the infant mortality increase is caused by COVID-19 vaccination, as the social media posts imply.

As we recently explained, multiple studies show COVID-19 vaccines are safe and beneficial for pregnant people and their newborns. According to the CDC, people who are pregnant are more susceptible to severe COVID-19, which can harm the mother and the baby. Infection with the coronavirus during pregnancy can also increase the risk of stillbirth. Vaccination during pregnancy can also protect babies from COVID-19 after birth, thanks to protective antibodies that are passed through the placenta.

There is no indication that breast milk after vaccination is unsafe either, as we’ve reported.

“We have extensive evidence that COVID-19 vaccination in pregnancy does not increase the risk that babies will die and may even decrease it,” Victoria Male, a lecturer in reproductive immunology at Imperial College London, told us in an email.

According to an online explainer created and updated by Male, 39 studies, across 10 countries, have tracked the safety of COVID-19 vaccination during pregnancy. Two systematic reviews and meta-analyses that include many of those studies found “COVID vaccination reduces the risk of stillbirth and babies needing intensive care, presumably because these can occur as a result of COVID infection,” she wrote. 

Eight of the 39 studies, which followed infants from birth to up to 1 year, found babies in the vaccinated groups didn’t show an increased risk for serious illness or death, Male added in the explainer. 

“Of these, seven found no effect of COVID-19 vaccination in pregnancy on infant deaths,” she told us, and one “found COVID-19 vaccination in pregnancy associated with a reduced risk of babies dying in their first 28 days of life.”

According to the CDC, COVID-19 vaccination is safe for people who are pregnant and does not increase the risk for pregnancy complications including miscarriage, preterm delivery, birth defects and stillbirth, as we’ve reported. For older babies who get them, COVID-19 vaccines may cause some temporary side effects, such as irritability and crying, injection site pain, sleepiness, fever, and loss of appetite, but serious adverse events are rare. Vaccination is recommended for babies beginning at 6 months old. 

“Extensive data on the safety of COVID-19 vaccination to pregnant women and their infants has shown no evidence of increased infant death after COVID-19 vaccination,” a spokesperson for the CDC told us in an email.

In 2021, when vaccines started being widely administered, the infant mortality rate was practically the same as 2020. A separate CDC report published in November shows that the fetal mortality, or stillborn, rate declined 5% from 2021 to 2022 in the U.S.

Possible Reasons for the Rise in Infant Mortality

The data do not point to a clear cause or causes for the one-year rise in infant mortality. But, experts told us, COVID-19 might partly explain the increase.

“Over time, we’ve learned that getting COVID-19 during pregnancy raises the chances of problems for both the pregnant person and the baby. This includes a higher risk of having a baby too early or having a stillborn baby,” a CDC spokesperson told us. 

Male told us data in the U.K. showed an increase in deaths of babies under 28 days old in 2021. 

“4.8% of these deaths were in babies whose mothers were infected with COVID at the time they gave birth, although it’s important to be clear that the data does not tell us whether COVID was a cause of death in these babies,” she told us.

Experts speculate the pandemic may also have impacted infant mortality in other ways. Dr. Patricia Gabbe, a clinical professor of pediatrics at the Ohio State University Wexner Medical Center, told NBC that pregnancy outcomes could have been affected by reduced access to proper prenatal care during the pandemic. 

The increase in pediatric RSV and flu infections seen after pandemic precautions eased “could potentially account for some of it,” too, Dr. Eric C. Eichenwald, chief of the neonatology division at the Children’s Hospital of Philadelphia, told the Associated Press.

The highest infant mortality rates continue to exist among infants of Black, American Indian and Alaska Native, and Native Hawaiian or other Pacific Islander people, according to the latest report.

“We do know that families in poverty face many challenges including access to nutritious food and affordable healthcare,” Dr. Sandy L. Chung, president of the American Academy of Pediatrics, said in a statement about the CDC’s report. “Racial and ethnic disparities related to accessible healthcare — including prenatal health services — are just one of the many possible reasons for lower birth weights of babies and sometimes, infant deaths.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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Male, Victoria. Lecturer in reproductive immunology at Imperial College London. Email to FactCheck.org. 13 Nov 2023. 

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Fleming-Dutra, Katherine E., et al. “Safety and Effectiveness of Maternal COVID-19 Vaccines Among Pregnant People and Infants.” Obstetrics and Gynecology Clinics of North America. Jun 2023.

McDonald, Jessica. “COVID-19 Vaccines Reduce, Not Increase, Risk of Stillbirth.” FactCheck.org. 9 Nov 2022.

McDonald, Jessica. “COVID-19 Vaccination Doesn’t Increase Miscarriage Risk, Contrary to Naomi Wolf’s Spurious Stat.” FactCheck.org. 24 Aug 2022.

Ely, Danielle M., and Anne K. Driscoll. “Infant Mortality in the United States: Provisional Data Infant Mortality in the United States, 2021: Data From the Period Linked Birth/Infant Death File.” Vital Statistics Rapid Release. 12 Sep 2023. 

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The post No Evidence of Link Between U.S. Infant Mortality Rate Increase and COVID-19 Vaccines appeared first on The Atlanta Voice.

SciCheck Digest

Being vaccinated against COVID-19 helps protect pregnant people from severe COVID-19. When given during pregnancy, the vaccines can also reduce the risk of hospitalization from COVID-19 early in a baby’s life. A new study adds to the evidence that vaccination during pregnancy is safe for babies, contrary to social media and online claims.

Full Story

Pregnancy puts people at elevated risk of severe COVID-19. Young babies also are particularly vulnerable to hospitalization from COVID-19. Maternal vaccination reduces these risks.

The mRNA COVID-19 vaccines come with similar side effects regardless of whether a person is pregnant. Research does not show increased risk of miscarriage, birth defects or other pregnancy complications after vaccination, and it indicates vaccination may reduce the risk of preterm birth and stillbirth. A study published Oct. 23 in JAMA Pediatrics adds to the evidence that the mRNA COVID-19 vaccines are safe and do not lead to problems for newborn babies and infants when given to their mothers during pregnancy.

Going against the now-extensive record on COVID-19 vaccines and pregnancy, a recent Instagram post claimed that there is “No Discernable Benefit of COVID-19 Vaccination in Pregnancy.” The post was quoting a Substack newsletter from Dr. Peter McCullough, a prolific spreader of vaccine misinformation. The newsletter focused on the new JAMA Pediatrics study on vaccine safety, also claiming that it found “No Assurances on Safety.”

“Surely there was no benefit of COVID-19 vaccination, so why expose mothers and infants to any risk at all?” the newsletter misleadingly concluded. We reached out to McCullough with questions but did not receive a response.

This contradicts the conclusions of the authors of the paper, who wrote, “Maternal mRNA COVID-19 vaccination during pregnancy was not associated with increased adverse newborn and early infant outcomes and may be protective against adverse newborn outcomes.”

The study was a safety study and was not meant to assess vaccine effectiveness in pregnant women, co-author Sarah C. J. Jorgensen, a pharmacist and postdoctoral fellow at the University of Toronto, told us. The researchers aimed to measure whether the babies of mothers vaccinated during pregnancy had any elevated risks of health problems. Jorgensen said the study “does provide more reassuring data on the safety of these vaccines for the newborns and infants.”

The Centers for Disease Control and Prevention recommends that people 6 months and older, including people who are pregnant, receive an updated COVID-19 vaccine. Other medical organizations, including the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, endorse this recommendation.

Study Bolsters Evidence for Safety of Maternal COVID-19 Vaccines

McCullough misused two pieces of raw data from the JAMA Pediatrics study to incorrectly imply that COVID-19 vaccination during pregnancy is unsafe and ineffective. He ignored the primary results of the paper supporting the safety of maternal COVID-19 vaccination for babies, as well as the larger body of data showing maternal COVID-19 vaccination is safe and effective.

The study used a database, called MOMBABY, that links health records of mothers and babies born in hospitals in Ontario, Canada. Jorgensen and her co-authors based their findings on data from more than 142,000 babies with due dates between May 2021 and early September 2022. 

The researchers compared babies born to mothers who received at least one mRNA COVID-19 vaccine dose during pregnancy with babies whose mothers had never been vaccinated against COVID-19 at all prior to giving birth.

McCullough misleadingly referenced unadjusted, or “crude,” data suggesting a very small increased risk of hospital readmission for all causes in newborns up to 4 weeks old born to vaccinated mothers. But the correct statistic to use to determine whether there is a difference in readmissions is the adjusted figure, Victoria Male, a senior lecturer in reproductive immunology at Imperial College London, told us via email. Male was not involved in the study.

There are many differences between people who do or do not take COVID-19 vaccines. Well-done studies track characteristics of people in the groups they are comparing so they can adjust for differences, such as whether they live in high-income areas or have a tendency to engage in healthy behaviors.

“The adjusted results, after accounting for differences in the characteristics of the different groups, show no increased risk for neonatal readmission between the two groups,” pediatrics and internal medicine specialist Dr. Malini DeSilva and statistician Gabriela Vazquez-Benitez told us in an email. Both researchers, who were not involved in the study, are affiliated with HealthPartners Institute and study vaccine safety in pregnant people.

DeSilva and Vazquez-Benitez added that the study did not show an increased risk for neonatal readmission with additional COVID-19 vaccine doses received during pregnancy. The study also followed babies through 6 months of age and found a similar rate of hospital readmission regardless of maternal vaccination status.

Jorgensen and her co-authors wrote that the slight increased risk of newborn readmission in the crude data could be explained by the elevated rates of death and severe health problems in newborns born to unvaccinated mothers. The sickest babies had either died or had not left the hospital by the age of 4 weeks and therefore could not be readmitted, so these babies were excluded from the hospital readmission analysis.

McCullough’s post also fails to highlight the study’s other findings, which indicate no association between the vaccines and negative effects on newborns. 

“The study finds that outcomes at birth are actually better for babies born following vaccination in pregnancy, and this finding is unchanged when the authors do additional analyses to take account of the fact that vaccinated families tend to have better healthcare in general,” Male said. The improvements for newborns included lower risk of severe problems such as hemorrhage or seizures, neonatal intensive care unit stays, and death.

It’s unclear how great of a role vaccines played in causing these lower risks. Maternal vaccination may have helped improve newborn outcomes by mitigating the risks associated with getting COVID-19 during pregnancy. But the authors of the paper wrote this was unlikely to fully explain the risk reductions they saw.

DeSilva and Vazquez-Benitez said that “healthy vaccinee bias,” in which people who get vaccines tend to be healthier and more likely to engage in healthy behaviors, could help explain the reduced risks of poor newborn health outcomes — despite attempts to adjust for these factors. They also pointed out that people who give birth earlier in their pregnancies will have less opportunity to get vaccinated. Being born too early can lead to health problems for babies.

Regardless, the reduced risk means it’s unlikely vaccination increased the risk of NICU stays, severe health problems or deaths in newborns, the researchers concluded. “It is at least reassuring that they are not elevated,” Jorgensen said.

McCullough had other critiques of the data used in the study. But he “misunderstands how the MOMBABY database works,” Male said. McCullough incorrectly wrote in his Substack post that if a mother delivered at one hospital and later took her baby to another hospital or clinic “for seizures, hemorrhage, etc.,” the pair wouldn’t be linked. 

The MOMBABY database captures all hospitalizations in Ontario, Jorgensen said, so admission to any hospital in the province would be recorded and linked to the mother. The study was not meant to capture visits to clinics, which likely would be routine or for more minor issues.

Finally, McCullough pointed out that the study did not report on miscarriage or stillbirth. “That’s true: this study was not designed to look into that,” Male said. But other studies have shown no effect of COVID-19 vaccination on the rate of miscarriage. And as we’ve said, vaccination may reduce the risk of stillbirth.

COVID-19 Vaccination Benefits Mothers and Babies

McCullough also highlighted data showing similar rates of positive COVID-19 PCR test results during pregnancy among vaccinated and unvaccinated women, seemingly to back up his statement that the vaccines have no benefit during pregnancy.

However, the work “wasn’t designed as a study to look at vaccine effectiveness for pregnant women,” Jorgensen said. The data on COVID-19 testing were provided in a table describing characteristics of vaccinated versus unvaccinated pregnant women, which were used to adjust for differences between the groups.

Jorgensen, Male, DeSilva and Vazquez-Benitez all pointed out that in this study, there wasn’t information on whether the vaccinated women who tested positive for COVID-19 got vaccinated before or after getting sick. “We therefore can’t use this data to tell us anything about the effectiveness of COVID vaccination at preventing infection,” Male said.

Studies designed to look at COVID-19 vaccine effectiveness have found that it is similar whether the vaccines are given to pregnant or non-pregnant individuals. In the omicron era, vaccination has provided significant protection against severe disease and more limited protection against symptomatic illness — with booster doses improving effectiveness.

Furthermore, people who get vaccinated during pregnancy can pass on antibodies to their babies via the umbilical cord and subsequently via breast milk, although the level of protection provided by the breast milk antibodies is unclear. Maternal vaccination during pregnancy is associated with reduced risk of infection and hospitalization from COVID-19 during the first six months of a baby’s life, and particularly during the newborn period, according to multiple studies. 

For instance, Jorgensen and her colleagues did a different study using the MOMBABY registry on the effects of maternal COVID-19 vaccination on babies during the first six months of life. Babies whose mothers had gotten the original primary vaccine series, including at least one dose during pregnancy, had a 45% lower risk of infection and 53% lower risk of hospitalization with omicron than babies of unvaccinated mothers. Protection was better if the mothers got at least one dose during the third trimester. With a booster dose during pregnancy, protection also increased, with babies having a 73% lower risk of infection and an 80% lower risk of hospitalization with omicron.

“Regardless of pregnancy status, COVID-19 vaccination remains the best protection against COVID-19-related hospitalization and death,” DeSilva and Vazquez-Benitez said. “In addition to reducing the risks of severe illness from COVID-19 in pregnant persons, COVID-19 vaccines administered during pregnancy can provide infants with antibodies against COVID before they are eligible to receive COVID-19 vaccines.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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