SciCheck Digest
COVID-19 vaccination during pregnancy benefits both mother and baby. Side effects are generally mild, and studies dont show negative effects on the baby. A criticized study that gave COVID-19 vaccines to pregnant rats doesnt show that vaccines cause autism or that people shouldnt get COVID-19 vaccines, contrary to claims.
COVID-19 vaccinationprotectspregnant people from severe COVID-19 and reduces COVID-19 risks for babies. As is the case in people who arent pregnant, side effects inpregnant peopleare usually mild and resolve within days. Studiesdo not showa link between COVID-19 vaccination and negative pregnancy outcomes or health problems for babies.
Long-standing claims that childhood vaccines cause autism have beenroundlydebunked. Long-term studies provide reassurance that vaccination during pregnancy againstfluandotherdiseases does not increase a childs risk of autism, a developmental disorder. And a recentstudydid not find a connection between maternal COVID-19 vaccination and increased risk of developmental delay at 18 months of age.
However, social media posts have misused findings from a recentstudyof COVID-19-vaccinated pregnant rats and their pups toback upunfounded claims that people should not take COVID-19 vaccines, or to promote unsubstantiated claims about vaccines and autism.
Im forever grateful I risked my reputation in my personal life to warn people far and wide to NOT get this experimental $h0t! said one post sharing an article from the Epoch Times on the new study.
Commentator Candace Owens, who has a history of spreading misinformation, shared a post about the study on X, the platform formerly known as Twitter, saying it supported long-standing, debunked claims about vaccines and autism. Thats because vaccines and autism have always been linked, which affected mothers have been trying to tell the general public for decades, she said. Posts about the study have continued to spread.
Researchers who study brain development expressed concerns to us about how the rat study was designed and interpreted.
The authors of the study, published Jan. 10 in Neurochemical Research, did behavioral and other tests on rats born to 15 female rats impregnated by five males. The pregnant rats either received an adult human-sized dose of the Pfizer/BioNTech vaccine against COVID-19 or a saline injection.
The researchers wrote that they observed autism-like behaviors, such as decreased interactions with an unfamiliar rat, and decreased neurons in regions of the brain in male rats born to vaccinated mothers. They also said they found alterations in the level of a particular protein in the brains of rats of both sexes born to vaccinated mothers.
Even if the results are taken at face value, its not possible to conclude from a study in rats that vaccines cause autism, because rat and human biology and behavior are different. Researchers do study rats to better understand autism, but these studies are meant to generate hypotheses, not change medical care.
Experts also told us there were various factors that made the study hard to interpret, such as the high vaccine dose given to the pregnant rats, despite their small size, the lack of replication of the experiment and issues with the statistical analyses.
Caution should be exercised in generalizing these results to humans, the authors themselves wrote in the paper. Corresponding author Mumin Alper Erdogan, a professor in the department of physiology at Izmir Katip Celebi University in Turkey, did not respond to a request for comment from us. However, he did answer questions from Health Feedback, responding to some criticisms and clarifying that there was no intention, desire, or effort on our part to oppose vaccinations or make similar accusations.
Vaccines do not cause autism, a spokesperson from the Centers for Disease Control and Prevention told us in an email. To date, no vaccine safety monitoring data in the United States indicates a causal association between autism and COVID-19 vaccination.
Multiple scientists expressed concerns to us about the high COVID-19 vaccine dose given to the pregnant rats.
Staci Bilbo, a neuroimmunologist at Duke University who studies how the immune system influences brain development, told us that vaccine doses are extremely carefully adjusted during vaccine development. Researchers determine the smallest dose that will generate the needed immune response.
Giving the rats which on average weighed less than 8 ounces a full adult human COVID-19 vaccine dose was equivalent to giving an average-weight American woman around 350 times the recommended dose of the Pfizer/BioNTech vaccine, according to Bilbos calculation.
If you give a high enough dose of anything its going to probably have impacts, she said.
In response to questions about the dose, Erdogan told Health Feedback that theres no established standard for mRNA vaccine dosages in rats due to the lack of specific dose studiesand that relatively high doses have been used for studies of other animalsof varying sizes.
Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvanias Perelman School of Medicine, also told FactCheck.org that the high dose given to the rats was a limitation of the study. This does not make the results irrelevant, since super high dose can potentially detect some potential issue that might manifest in some humans, but if I were reviewing this article I would make the authors emphasize the multiple of how much larger the effective dose in the animal study is to the current human dose, and include the qualifier that this is one reason why it is not clear whether these results are relevant to what is experienced by humans given the current doses.
Christopher Coe, a psychoneuroimmunologist and professor emeritus at theUniversity of Wisconsin-Madison, told us via email that were it his study, he would also have wanted to give the rats a low dose of the vaccine to see if results varied by dose. Coe has done studies on the effects of infection and maternal inflammation on the fetus during pregnancy.
Coe said it was important to take reports of drug or vaccine adverse events seriously, but he also listed numerous other concerns about the paper.
For example, he said the researchers did not provide information about the rats and their pregnancies that could have shed light on how the injections affected them and whether or not this was likely to be relevant to humans. This missing information included, for instance, whether the rats had an inflammatory reaction to the injections the hypothesized pathway for how vaccination during pregnancy might affect neurodevelopment.
Teresa Reyes, a professor of pharmacology and systems physiology at the University of Cincinnati College of Medicine, told us via email that information was missing on the length of the rat pregnancies. If the pregnancy length was significantly different, it could indicate that the litters were born prematurely, which confounds the interpretation of the findings, she said.
In humans, COVID-19 vaccination during pregnancyhas not been shownto increase preterm birth and may even protect against it.
She also said that information was missing on the weights of the pregnant rats, or dams, over time and their pups. Significant differences in weight (e.g., vaccine exposed dams lost weight during the study) could indicate that the dams were severely ill in response to the vaccine, again confounding the interpretation of the study, she said.
Coe said that he would have wanted to replicate the findings rather than rush to publish on the basis of one experiment, suggesting that both the authors of the paper and outside researchers should try to replicate the results.
And he expressed concern about the studys statements that altered rat behaviors were autism-like, given that autism spectrum disorder is a complex neurodevelopmental disorder.
Brian Lee, anassociate professor of epidemiology and biostatistics at the Drexel University Dornsife School of Public Health who studies prenatal exposures and autism risk, told us via email that it is hard to diagnose autism in humans, let alone in rats. Its hard to read into some behavioral tests for a rat and imagine it translates 100% to an autism diagnosis in humans, he said.
There also appeared to be issues with the studys experimental design and statistical analysis.
For instance, studies of prenatal exposures need to account for something called litter effects or the fact that the multiple offspring born in the same litter to the same animal mother might share characteristics.
The authors did not describe any approach to address the potential for a litter confound which could skew the findings (e.g., one dam has a significantly different response, multiple pups are used from that litter, and this skews the findings), Reyes said.
Additionally, the authors wrote that they set out to determine whether maternal vaccination led to any sex-specific neurobehavioral changes or ways in which sex and vaccination, in combination, affected the rats behavior.
The authors didnt find evidence of such sex-specific effects on social behavior, but theynevertheless went on to compare social behavioral results from the male pups of vaccinated mothersversus unvaccinated mothersand highlighted the results something Reyes said they shouldnt have done. By improperly using statistics to analyze the data, the conclusions are not valid, she said. It is impossible to verify the stated claims because statistics were used incorrectly.
A persons likelihood of being autistic isinfluencedby a combination of genetics and other factors. These likely include older parental age and whether there are complications at a childs birth,includingextreme prematurity or very low birth weight. As weve writtenpreviously, many lines of evidence contradict the idea long spread by anti-vaccine groups that childhood vaccines cause autism.
Some theoretical concerns about vaccines given during pregnancy and autism are based on researchindicatingthat infections during pregnancy might slightly increase the risk of a child later developing autism.We know that immune activation can impact the way the brain develops, and sometimes thats in adverse ways and yet we also know that the immune system is important in just normal brain development, Bilbo said.
But Bilbo said the bodys immune system reacts differently to a serious infection than it does to vaccination.A vaccine against a virus is designed to expose the body to just enough viral material to teach the immune system to recognize the infectious agent, should it encounter it later. Dose matters, obviously, Bilbo said. It matters quite a bit.
Studies in humans provide reassurance of recommended vaccines benefits and safety.
The Tdap vaccine which protects against tetanus, diphtheria and pertussis, orwhooping cough isrecommendedduring pregnancy to protect newborns until they are able to be vaccinated against pertussis themselves at two months of age. The CDC began to recommend the vaccine routinely in all pregnancies in2012, based on an uptick in pertussis, which can lead to death in very young babies.
A 2018studyof children born in Kaiser Permanente Southern California hospitals between 2011 and 2014 found no increased risk of autism in those whose mothers had been vaccinated against Tdap during pregnancy.
Flu vaccines havelongbeenrecommendedfor pregnant people during flu season and reduce risks for both the mother and the baby. A 2020 Swedishstudylooking at vaccination against the 2009 pandemic swine flu found no link between vaccination during pregnancy and increased autism risk.
A 2017study, looking at children born in the Kaiser Permanente Northern California health system between 2000 and 2010, found no association overall between autism and flu vaccination during pregnancy. The researchers did find a suggestion of increased autism risk when mothers were vaccinated during the first trimester of pregnancy but said that statistical analyses indicated the finding could be due to chance.
In the case of COVID-19 vaccines, researchhas not indicatedany negative impacts on pregnancy outcomes or on babies of vaccinated mothers. In fact, theres some evidence maternal vaccination is protective against certain bad pregnancy outcomes, such as preterm birth and stillbirth.
Astudypublished on Jan. 22 in JAMA Pediatrics followed around 4,200 children born to mothers who enrolled in the study between May 2020 and August 2021. At 18 months, scores on a developmental screening test did not differ between children whose mothers got COVID-19 vaccines during pregnancy versus those whose mothers didnt.
The authors wrote that these data suggest that maternal vaccination against COVID-19 during pregnancy was safe from the perspective of offspring neurodevelopment through 18 months of age.
Its small and just 1 study, and of course more study is needed, but the findings are reassuring, said Drexels Lee, who was not involved in the new study.
Coe emphasized the benefits of COVID-19 vaccination during pregnancy. There are now many clinical studies that have demonstrated the benefits for safer pregnancy outcomes (as compared to the risk of an actual infection), as well as the reduced risk for young infants of getting a respiratory infection during the first 6 months of life, he said.
There is no known link between COVID-19 vaccines and the occurrence of autism spectrum disorder (ASD), a Pfizer spokesperson told us in an email. With hundreds of millions of doses of COVID-19 vaccines from BioNTech and Pfizer administered globally, the benefit-risk profile of our vaccines remains positive for all authorized indications/uses and age groups.
Editors note: SciChecks 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.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.
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Erdogan, Mumin Alper et al. Prenatal Exposure to COVID-19 mRNA Vaccine BNT162b2 Induces Autism-Like Behaviors in Male Neonatal Rats: Insights into WNT and BDNF Signaling Perturbations. Neurochemical Research. 10 Jan 2024.
Jackie | bootleg media (@bootlegmedia__). How does Anthony fauci sleep at night Instagram. 13 Jan 2024.
Athrappully, Naveen. COVID-19 Shots Linked to Autism in Vaccinated Rats: Study. Epoch Times. 13 Jan 2024.
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shanna scrunchy mama | organic humor | holistic. I wonder what they will find out next about this shot Instagram. 19 Jan 2024.
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Morris, Jeffrey S. Email to FactCheck.org. 25 Jan 2024.
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Key Takeaways
Analysts are projecting another difficult quarter for Pfizer Inc. (PFE) in which the company likely suffered a steep drop in revenue as demand for its COVID-19 products declined.
Pfizer is expected to detail adjusted losses of $1.1 billion or 19 cents a share, according to analyst consensus compiled by Visible Alpha, when it issues its earnings report on Jan. 30. For the same period in 2022, the company reported adjusted net income of $6.55 billion or $1.14 per share. The adjusted net loss excludes impact of intangibles, acquisitions and discontinued operations.
Pfizer had to lower its 2023 guidance in October as the demand for its COVID products waned and that continued to weigh on its results. Analysts expect a 40% year-over-year drop in revenue to $14.3 billion in the quarter.
After Pfizer has struggled amid poor demand for its COVID-19 products, including its Paxlovid treatment and the Comirnaty vaccine, investors will want to watch for the companys reported revenue from this segment. Analysts are projecting sales of the vaccine to fall 52% in the fourth quarter to $5.44 billion, coming after three straight quarters where COVID-19 vaccine sales were lower by more than 70%.
Additionally, as Pfizer looks for new market segments to drive growth, analysts forecast that it will grow sales of its Vyndaqel line of heart medication by 38% in the quarter to more than $942 million.
While its COVID-19 revenue fades, Pfizer also has faced some setbacks as it seeks other pipelines for growth. It ended a study of its weight-loss pill because of negative side effects, as it seeks to find an effective oral weight-loss drug to compete with injectables like Novo Nordisk ASs (NVO) popular Ozempic treatment. Its also fighting off a threat from generic competition to its Vyndaqel heart medication.
Pfizers share price was walloped in 2023, falling as much as 42% over the year. In December 2023, the stock tumbled to its lowest level in more than 10 years after it warned revenue would decline in 2024 as demand for COVID products continued to fall. And, so far this year, Pfizer shares have continued that losing streak, down roughly 7% year-to-date.
Brianne Dressen rested her sore arm on the car door and closed her eyes. It was Nov. 4, 2020, and shed just gotten her first dose of a COVID-19 vaccine. She and her husband had been running errands that afternoon. They stopped for her appointment, and he was driving her home. They hadnt gotten very far when Dressen noticed a painful tingling sensation in her arm.
Something doesnt feel right, she said.
Not long after they got home, Dressen knew something was definitely wrong. Her vision began to blur and her hearing was off, as if she had big seashells covering her ears. After putting her children to bed, she tried to distract herself by watching television. But the single screen morphed into two screens stacked on top of each other. Even as she wondered whether this was a normal reaction to the vaccine, she had no idea how bad her symptoms were about to get.
When COVID-19 vaccines became available in late 2020, millions of Americans lined up to get them, hoping to finally bring an end to the nightmare of the pandemic. Over 80 percent of Americans got at least one dose of a vaccine. Some of them, like Dressen, believe they suffered a serious adverse reaction, or vaccine injury.
No one knows exactly how many people suffered a COVID-19 vaccine injury, but it likely runs into the tens of thousands. Public health officials acknowledge, in theory, that vaccine injuries can occur. But in practice, they are loath to recognize any victims, possibly because they fear vaccine opponents would seize upon such cases. Even before the advent of the COVID-19 shots, the government had a poor track record of caring for people with vaccine injuries.
During the pandemic, people like Dressen tried to do the right thing by getting vaccinated. But she and others who experienced adverse effects became collateral damage in the public controversy over vaccine safety. The trauma of being dismissed and gaslit by medical teams is actually just as traumatic as the injury itself, she told me.
Dressen, a wife and mother of two young children, worked as a preschool teacher when the pandemic hit. She and her husband took COVID seriously. Her job meant she was considered high risk. I dont know if youve ever seen little kids in masks, but it never goes well, she said.
Dressen, who lives in Utah, was in great physical shape, often going hiking and mountain-climbing on her days off. She had taken vaccines her whole life without any problems, so when she was offered the chance to participate in the clinical trial for AstraZenecas COVID-19 vaccine, she didnt hesitate. I loved those kids. I loved their families. I knew some of them had high-risk grandparents [living] with them, and I didnt ever want to be the reason why anyone else died or was harmed in any way.
The morning after she got her shot, Dressen discovered she couldnt walk normally. She bumped into doorways as her left leg kept giving out. She made it to work, but the childrens voices sounded unbearably loud. Eventually, she put them in front of an educational TV show and huddled in a corner until their parents arrived. That was the last day of preschool she ever taught.
Nearly every aspect of the public health response to the pandemic generated controversy, nothing more so than the vaccine. Mandates, from both the government and private employers, further stoked resentment. Some Americans were forced to choose between their livelihoods and a vaccine they didnt want to take. For example, more than 8,000 military service members were discharged for refusing the shot, though Congress has now established a path for them to rejoin.
Many worried about the speed with which the vaccines came to market. It normally takes five to 10 years or longer for a new vaccine to reach the public. But doctors insist safety was always a top priority and has never been compromised.
Paul Goepfert is a professor of medicine at the University of Alabama at Birmingham. He called vaccine trials a very rigorous process.
We do phase 1-2 studies, which is just in a few peoplewe just want to make sure that its immunogenic, and there are no huge safety issues, he said. This is followed by much larger phase 3 trials. For the COVID-19 vaccines, these included tens of thousands of participants.
Once the vaccines became available to the public, health officials began looking for signs of trouble. I think people dont understand the whole context, and all the real-time surveillance going on, said Amesh Adalja, an infectious disease specialist and senior scholar at the Johns Hopkins Center for Health Security. Adalja insists public health officials are especially alert to potential problems with the COVID vaccines because they know many people have concerns about them.
ER Productions Limited/Getty Images
FOR DAYS AFTER her symptoms started, Brianne Dressen left frantic voicemails with the clinic that had administered the shot. The painful tingling that started in her arm had spread all over her body, and the effect was like a series of internal electric shocks. She lost control of her legs and her bladder. She developed tinnitus that sounded like a freight train in one ear and ringing in the other. She was so sensitive to sound, light, and touch that she had to stay in a dark room alone. Her children could not be near herthe stimulation was too painful.
The clinic didnt return her calls for several days but eventually brought her in for tests. Health workers there suggested she might have had an underlying case of multiple sclerosis and promised they would report her experience to AstraZeneca.
I still have yet to speak to an actual person at AstraZeneca, to this day, Dressen said, three years later. The company withdrew its application for FDA approval after long delays caused by irregularities in its trial data. Still, its vaccine was approved and widely used in Europe.
As Dressens symptoms spiraled, she went to the emergency room four times before finally being admitted to the hospital. Doctors diagnosed her with anxiety due to the COVID vaccine.
Dressen herself was too weak to speak. But her husband Brian said, Are you kidding me?
The anxiety diagnosis haunted Dressen as she went to other appointments, where more doctors told her the problem was all in her head. Her husband is a biochemist. Desperate to help his wife, he reached out to other scientists around the world. Eventually, his networking connected Dressen with Avindra Nath, a senior investigator specializing in the nervous system at the National Institutes of Health (NIH). In June 2021, the NIH flew Dressen and about 20 other people who believed they had a COVID vaccine injury to its headquarters for study and treatment.
During that trip, researchers diagnosed Dressen with post-vaccine neuropathydamage to the peripheral and small fiber nerves. They contacted her doctors in Utah to confirm her diagnosis.
That made life easier, at least when it came to getting treatment. But after that, the NIH canceled a follow-up trip in September 2021. Three months later, Nath asked her to stop telling others with vaccine injuries to contact him. He said they should get care from their local doctors instead.
When I emailed Nath to get his side of the story, an NIH media representative referred me to the FDA, which in turn referred me back to the NIH. But emails Dressen provided confirmed her account of their conversations.
RESEARCH INTO a vaccines safety does not stop once its approved. Public health officials engage in extensive real-time surveillance to spot potential problems. To that end, the Centers for Disease Control and Prevention (CDC) developed V-safe specifically for the COVID-19 vaccines. Its a text messaging system that lets people report health issues after they get vaccinated. Over 10 million people participated in V-safe.
The Vaccine Adverse Event Reporting System (VAERS), a database co-managed by the CDC and FDA, is another critical surveillance tool. VAERS collects information about health events after any vaccinenot only COVID-19 shots. Private individuals and medical professionals can submit reports. Human beings experience all kinds of health events all the time, so symptoms suffered soon after vaccination arent necessarily caused by the vaccine. If VAERS shows a higher-than-normal rate of certain health problems, it sends out a safety signal. Officials then notify the Vaccine Safety Datalink, a collaboration between the CDC and 13 healthcare organizations across America. Goepfert says that allows doctors to look for those specific health effects among their patients.
Adalja notes the Department of Defense first flagged myocarditis, now a widely acknowledged adverse event from the COVID-19 vaccine, as it monitored service members who got the shot. That prompted multiple CDC meetings and calls and everything about it when they detected that signal, Adalja said.
Goepfert cited the Johnson & Johnson (J&J) vaccine, which he helped develop, as an example of prioritizing safety. It was one of the first three major COVID-19 vaccines approved in the United States, along with shots from Pfizer and Moderna. But the company took it off the market due to a small number of cases of a rare blood clotting disorder.
Still, all that vaccine monitoring has led to a list of confirmed side effects that, when compared with the broad array some shot recipients say they have experienced, is notably short. The CDC acknowledges anaphylaxis (an acute allergic reaction), myocarditis, and pericarditis for all COVID-19 vaccines. It also acknowledges Guillain-Barr syndrome (the immune system attacking the nerves) and thrombosis with thrombocytopenia syndromethe blood clotting disorderbut only for the J&J vaccine. Tinnitus and paresthesia are listed as side effects in Europe but not in America.
Spencer Platt/Getty Images
JOEL WALLSKOG is an orthopedic surgeon who lives in Wisconsin. When the pandemic hit, he worked for a large healthcare system in and around Milwaukee. Wallskog had an asymptomatic case of COVID-19 in fall 2020 that he believed gave him natural immunity, so he debated not getting a vaccine.
But then I had a good friend of mine that had COVID and almost died and got intubated and got a tracheostomy, and that kind of gave me a little shake-up, he said.
When he got an email announcing it was his turn to get vaccinated during the rollout to healthcare workers, he drove to a hospital in Milwaukee and rolled up his sleeve for the Moderna shot.
That was Dec. 30, 2020. A few days later, as he climbed out of bed on a cold Wisconsin morning, he noticed his feet were numb. Hed had neck problems and a herniated disk in the past but never issues with his legs. A few days later, though, he was talking to a patient when he realized he could not stand up. He tried to push himself up with his arms and fell down backward.
He immediately ordered himself an MRI, multiple labs, and a spinal tap. Being in the healthcare system, I can navigate it very quickly, he said. A fellow doctor diagnosed him with transverse myelitis, an inflammation in part of the spinal cord. He recalled reading that the clinical trials of AstraZenecas COVID-19 vaccine in the United Kingdom had been paused over cases of the same condition.
Wallskog reported his condition to VAERS and made multiple calls to the CDC. One of its physicians finally got back to him. They said theyd look into my case, and I never heard back. Ever.
Today, Wallskog can only stand or walk two to four hours a day. Both his blood pressure and heart rate are erratic and usually high. Worse, he randomly loses consciousness. As a result, Wallskog was forced to stop working as a surgeon.
After his diagnosis, Wallskog started speaking out about his condition. A year and a half later, the healthcare system that still technically employed him launched an investigation into alleged prescribing irregularities.
Wallskog views the investigation as an attempt to intimidate him into silence about his vaccine injury. It was a threat, he said. The message was clear, which was for me to shut up. But I didnt. I became more vocal.
The investigation went nowhere, and he eventually took early retirement using his private disability insurance.
BRIANNE DRESSEN initially kept quiet about her injury. She believed her case must be highly unusual and did not want to discourage others from getting vaccinated. She told the parents of her preschool students only that she was too sick to continue teachingbut she didnt share the cause of her sickness. Over time, however, she started connecting online with other injured people. Many of them had also been diagnosed with conditions like anxiety. She knows of many people who were even driven to suicide.
I stopped counting at 20, she told me, but she estimates the number may be as high as 27. Often these people had family members who did not believe the vaccine caused their symptoms. Dressen decided she had to speak up for them: I wouldnt have believed its as bad as it actually is had I not lived through it firsthand.
In November 2021, Dressen met Wallskog at a press conference in Washington, D.C. Sen. Ron Johnson, a Republican from Wisconsin, hosted the event, which featured scientists and people with vaccine injuries. But it didnt raise the kind of awareness they had hoped. The scant media coverage focused instead on Johnsons history of vaccine skepticism.
Wallskog, Dressen, and others talked afterward and made plans to start a nonprofit to help people like themselves. They named it React19. Dressen says the organization aims to provide emotional, physical, and financial support to those harmed by the COVID vaccines. Today, React19 has over 30,000 members who believe they were injured.
React19 conducts extensive surveys of its members and has found many of them report symptoms similar to long COVID, including fatigue and brain fog. The demographics are similar, with women far more likely to be affected than men. The symptom members say they would most like to be rid of is painful neuropathy. The CDC does not currently acknowledge any of the neuropathic symptoms.
React19 members also frequently report cardiovascular issues, such as rapid heart rate and heart palpitations, and a smaller group reports autoimmune conditions.
No one knows how many people have suffered a COVID vaccine injury. Adverse reactions are both complex and rare, when compared with the number of people whove received one or more shots, so it takes time for doctors to understand them. The symptoms themselves are also difficult to track and categorize: Some symptoms reported to VAERS or doctors are actually not connected to the vaccine, while genuine vaccine-related symptoms may go unreported.
Several foreign countries have studied this issue, including Germany. The Marburg University Hospital, which treats COVID-19 vaccine injuries, estimates that 0.2 per 1,000 vaccinated persons suffered an adverse event, or 1 in 5,000 people. If that number held true in the United States, it would amount to 54,000 injured people.
On social media, discussion about adverse COVID vaccine events has focused on sudden deaths of young people, supposedly resulting from myocarditis. Dressen and Wallskog say thats a serious concern, but they find it unhelpful to speculate without a confirmed link to a COVID vaccine. Both say that only leads to further polarization over the vaccine.
Wallskog insists on looking at the data. Lets make sure they get autopsies, and lets figure it out versus just this reactionary thing, where every death is from the shot, because I dont think thats true.
Dhiraj Singh/Bloomberg via Getty Images
DOCTORS HAVE long acknowledged vaccines can cause adverse events and even death in extremely rare cases. Despite that, the victims of vaccine injuries struggle to get the help they need.
In the 1980s, Congress established the Vaccine Injury Compensation Program (VICP), also called the vaccine court, as a way to provide compensation. It serves as a no-fault alternative to traditional lawsuits. Congress created the program after several huge, vaccine-related jury awards threatened to cause vaccine shortages and reduce vaccination rates. When it began, VICP only covered six vaccines for children. Now it covers 16, including the annual flu shot offered to adults.
Attorney Rene Gentry has practiced vaccine-injury litigation for 20 years. She says adding the flu vaccine in particular exponentially increased the number of people eligible to file claims.
But the vaccine court itself never grew. Gentry says the biggest bottleneck is the lack of special masters, the vaccine courts equivalent of judges. VICP began with eight and that number never increased. As a result, claimants face long delays to get the financial help they need to pay their medical bills. The day before we talked, Gentry argued a case before the vaccine courta date that had been scheduled two years before. She has seen cases in which seniors injured by the flu vaccine died before their claim was resolved.
COVID-19 vaccines do not currently fall under the VICP because they were developed in response to a public health emergency. And COVID vaccine makers are exempted from legal liability under the Public Readiness and Emergency Preparedness Act of 2005. But people like Dressen can apply for help with medical bills, and families can apply for death benefits, under a program called the Countermeasures Injury Compensation Program (CICP) run by the Department of Health and Human Services (HHS).
Gentry calls CICP a dumpster fire of a program. Before the pandemic, it had received about 500 claims, mostly related to the H1N1 vaccine. Only 30 of those were compensated. After the pandemic, 9,500 claims connected to the COVID-19 vaccine flooded the system, plus another 3,000 claims for other COVID treatments. People who call Gentry tell her they spend entire days on hold with HHS without ever reaching a human being. Dressen applied for compensation and has been waiting two years for a response. In October 2023, React19 filed a lawsuit against the HHS alleging the CICP is unconstitutional because it violates the right to due process and a jury trial.
A bill proposed in Congress, the Vaccine Injury Compensation Modernization Act of 2023 (H.R. 5142), would transfer COVID vaccine claims out of CICP and over to VICP. The legislation faces a hard road because vaccines are still a loaded subject. But Gentry is hopeful it will pass. I think if you want a strong, universal immunization program and you want to protect thatwhich I think we do for public healthyou have to have a vibrant safety net, she said. And the safety net is showing a lot of wear and tear right now.
React19 isnt waiting for the government to act. It has raised over $600,000 to fund grants of up to $10,000 to help members with medical bills. Id like to do more, but its certainly more than the compensation program from the HHS, Wallskog said. He helps review medical bills to determine eligibility.
These days, Dressen manages her pain by getting intravenous immunoglobulin every two weeks and following a strict hydration, food, and sleep routine. She takes several prescription medications, particularly at night so she can sleep.
Every morning, Im greeted by this horrific electrical pulsing in my body when the meds wear off, she said. The toll on her health has been ruinous. Her dream is to live long enough to see her children graduate high school.
On top of all her medical challenges, Dressen sometimes faces abuse online. A few days before we talked, someone on social media told her she belongs in hell because she is enabling liars and spreading fear. This kind of abuse doesnt faze her. I dont know how anybody could see what Ive seen and just turn away from it and not lean in to try to fix it.
Health experts are calling for government intervention in the wake of rising COVID outbreaks and plummeting vaccination rates in aged care.
The Department of Health released new data last week that revealed only 30.3 per cent of aged care residents had received a booster dose in the last six months and 68.1 per cent since January 2023.
That comes as there are 459 active COVID outbreaks nationally within aged care facilities, which translates to 2,135 active cases.
In NSW alone there are 146 outbreaks and 688 infections.
Aged care consultant Paul Sadler said he was "concerned" about the numbers.
"The total number of outbreaks and cases is ticking back up a bit at the moment. And it looks like we might have another wave. It could be affecting a large number of homes," he said.
"We've still got 32 people in the last week that died in aged care, so we still have a level of COVID impacting people tragically within the sector."
The Australian Technical Advisory Group on Immunisation recommended from September last year that all those aged 75 and over should get a booster dose every six months, and it should be considered for all adults aged 65 to 74.
RSL LifeCare, which manages 29 retirement homes, has had seven outbreaks in the last month, five of which are still active.
A spokesperson for the clinical care team said the organisation was "vigilant and cautious" when it came to outbreaks butadded that "despite our best efforts, we cannot always prevent COVID-19 entering aged care facilities".
"Our management and care staff teams, in partnership with our consumer's GPs, are always concerned about levels of COVID and other illnesses in the community," they said.
Mr Sadler said the reason behind the falling vaccination rate was either because facilities were treating the virus like other diseases or society's laxity towards COVID had spread to aged care.
"The levels of people who are up to date (with their vaccines) within six months in the community have been falling and I think that's about the effectiveness of public health messaging and governments treating this as a post-pandemic phase."
Adrian Esterman, an epidemiologist at the University of South Australia, is more alarmed by the government's response.
"What's more concerning is that the government say that this is a priority area to get the residents up to date with their booster shots and yet the actual percentage who are up to date is going backwards," he said.
"These are our most vulnerable people."
Professor Esterman said the government's lack of "care" made the population less concerned about the pandemic.
"The government has been downplaying COVID-19 now for a year or so," he said.
"But we are still actually still in a global pandemic, and we are still seeing successive waves of COVID-19, which aren't particularly predictable."
"There's this downplaying about how bad things are, and they are bad."
He also raised further issues when it came to vaccinating the elderly and transporting doses to facilities.
"Many of the residents in aged care facilities are demented. That means that if you want permission to vaccinate them you have to get permission from their guardian. So you got this logistical issue of trying to sign up to actually vaccinate them," he said.
"There's also things like the current vaccine requires extremely cold temperatures to transport them."
Professor Esterman said these issues "were all interplaying" but the primary reason "why we're not seeing enough of our aged care residents vaccinated is simply one of complacency from the government downwards".
When asked about how to improve the numbers, Mr Sadler recommended better messaging and reintroducing COVID-safe measures.
"I think if the rate of infection gets any higher and the number of outbreaks continue to grow then it would be very sensible for the government to resume some of the measures they put in place during the height of the pandemic two years ago," he said.
"I'm not suggesting we should go back to lockdowns but absolutely we should allow families to see their residents in aged care, but we need to be trying to improve the vaccination rate."
Professor Esterman called for face mask mandates in aged care facilities to be reintroduced and more GP visits.
GPs and nurses primarily administer booster doses for residents.
"If I was running the place, which unfortunately I'm not, the first thing I'd do would be to reintroduce face mask mandates for staff and visitors," Professor Esterman said.
"It's one thing we know works.Yet it's not mandated, it's left to each facility to decide whether people should wear a face mask or not. To me that's a big cop out."
The Department of Health said it "strongly encouraged" those at "higher risk of severe health outcomes from COVID-19" to be up to date with their booster doses.
"The Department of Health and Aged Care recognises that COVID-19 continues to disrupt the lives of Australians, and as such would like to see the vaccination levels as high as possible for those whom vaccination is recommended,'" a statement read.
The department said it regularly conveyed the importance of vaccines, masks and COVID-19 safe behaviours through the media and social media.
However, there was an acknowledgement that some aged care residents "may not choose to have the booster for a variety of reasons including COVID vaccine fatigue, eligibility, localised COVID outbreaks and potentially waiting for a new vaccine".
In first results from a study that tracked neurodevelopmental differences in babies born to mothers who were vaccinated against COVID-19, researchers found no differences at the 12- and 18-month marks compared to babies born to unvaccinated moms.
The team, from the University of California, San Fransisco, published its findings yesterday in JAMA Pediatrics. Against the backdrop of vaccine hesitancy among pregnant women and even in some of their healthcare providers, the researchers said their goal was to address unanswered questions about the longer-term impacts of COVID vaccination on developmental outcomes.
In the prospective cohort study, the researchers enrolled women who were less than 10 weeks pregnant and their babies in the online study from May 2020 to August 2021, including participants from all 50 states. Of those, 89.3% were White. Of 2,487 women enrolled in the study, 68% said they were vaccinated, of whom 76% reported receiving an mRNA vaccine.
Researchers collected demographic information about the mothers, then tracked babies' neurodevelopment remotely using the Ages and Stages Questionnaire that was completed by the mothers when the children were 12 or 18 months old. The group's analysis includes 2,261 babies who were 12 months old and 1,920 who were 18 months old. Follow-up of the children is ongoing.
The validated screening tool is designed to examine five areas, including communication, gross-motor, fine-motor, problem solving, and social skills.
Crude analysis found that, at 12 months, 30.6% of infants exposed to the vaccine while mothers were pregnant had an abnormal screening result, compared to 28.2% of unexposed infants. At 18 months, the percentages were 20.1% and 23.2%, respectively.
When investigators adjusted for maternal age, race, ethnicity, education, income, maternal depression, and anxiety, however, they found no difference in abnormal neurodevelopmental screening results. Adjusting for preterm birth and infant gender also had no impact on the results.
Concerns about the impact of COVID vaccination on offspring are understandable, and questions about the effects of vaccination on cytokine profiles and inflammatory response are still unclear, the authors wrote. They noted that early clinical data can provide useful clues.
They said earlier studies on fetal exposure to SARS-CoV-2 showed mixed results regarding neurodevelopment, but none had data on maternal COVID vaccination.
"Our findings more generally underscore the importance of ongoing prospective investigations in large, diverse cohorts of children across development, to provide an evidence basis for real-time clinical guidance in the setting of novel exposures to mothers and infants," they wrote.
(Precision Vaccinations News)
Novavax, Inc. today announced that the United Kingdom's (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorizationfor Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)for active immunization to prevent COVID-19 in individuals aged 12 and older.
Recent data indicate Novavax's vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants.
"Today's MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on January 24, 2024.
"We are in ongoing conversations with additional U.K. partners to identify potential opportunities to offer our protein-based non-mRNA COVID-19 vaccine to all eligible individuals who want one."
"We believe this is critical to supporting long-term, broad uptake of a seasonal COVID-19 vaccine in the U.K."
In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.
If peopleare concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found athttps://coronavirus-yellowcard.mhra.gov.uk/.
The U.K. authorization wasbased on non-clinical datashowing that Novavax's updated COVID-19 vaccine induced functional immune responses for XBB.1.5, XBB.1.16, and XBB.2.3 variants.
Additional non-clinical data demonstrated that Novavax's vaccine-induced neutralizing antibody responses to subvariants JN.1, BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6, as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.
In 2023, the U.S. Food and Drug Administration amended its authorization for Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 and older, to include the2023-2024 formula.
Novavax COVID-19 vaccine brands includeNuvaxovid,NVX-CoV2601, CovoVax, NVX-CoV2373, andTAK-019,Trademark filing#90813423.
News
Dr Lara Herrero and Wesley Freppel assess the latest evidence, including the impact vaccination and emerging variants can have.
Nearly four years into the pandemic, Australia, like many other countries, is still seeing large numbers ofCOVID cases. Some 860,221 infections were recorded around the country in 2023, while 30,283 cases have already been reported in 2024. This is likely to be a significant underestimate, with fewer people testing and reporting than earlier in the pandemic, but the signs suggest parts of Australia are experiencing yetanother COVID surge. While some lucky people claim to have never had COVID, many are facing our second, third or even fourth infection, often despite having been vaccinated. You might be wondering, how long does immunity last after a previous infection or vaccination? Lets take a look at what the evidence shows. B cells and T cells To answer this question, we need to understand a bit about howimmunityto SARS-CoV-2 works. After being infected or vaccinated, the immune system develops specific antibodies that can neutralise SARS-CoV-2. B cells remember the virus for a period of time. In addition, the immune system produces memory T cells that can kill the virus and remain in the blood for some months after the clearance of the infection or a vaccination. A2021 studyfound 98% of people had antibodies against SARS-CoV-2s spike protein (a protein on the surface of the virus that allows it to attach to our cells) one month after symptom onset. Six to eight months afterwards, 90% of participants still had these neutralising antibodies in their blood. This means the immune system should have recognised and neutralised the same SARS-CoV-2 variant if challenged within 68 months (if an infection occurred, it should have resulted in mild to no symptoms). But what about when the virus mutates? As we know, SARS-CoV-2 has mutated over time, leading to the emergence of new variants such as Alpha, Beta, Delta and Omicron. Each of these variants carries mutations that are new to the immune system, even if the person has been previously infected with an earlier variant. A new variant likely wont beperfectly recognised or evenrecognised at all by the already activated memory T or B cells from a previous SARS-CoV-2 infection. This could explain why people can be so readily reinfected with COVID. A recentreview of studiespublished up to the end of September 2022 looked at the protection conferred by previous SARS-CoV-2 infections. The authors found a previous infection provided protective immunity against reinfection with the ancestral, Alpha, Beta and Delta variants of 85.2% at four weeks. Protection against reinfection with these variants remained high (78.6%) at 40 weeks, or just over nine months, after the previous infection. This protection decreased to 55.5% at 80 weeks (18 months), but the authors noted there was a lack of data at this time point. Notably, an earlier infection provided only 36.1% protection against a reinfection with Omicron BA.1 at 40 weeks. Omicron has been described as animmune escape variant. A prior infection showed a high level of protection against severe disease (above 88%) up to 40 weeks, regardless of the variant a person was reinfected with. What about immunity after vaccination? So far, almost 70 million COVID vaccineshave been administeredto more than22 million peoplein Australia. Scientists estimated COVID vaccines prevented around14.4 million deathsin 185 countries in the first year after they became available. But we know COVID vaccine effectiveness wanes over time. A2023 reviewfound the original vaccines were 79.6% and 49.7% effective at protecting against symptomatic Delta infection at one and nine months after vaccination, respectively. They were 60.4% and 13.3% effective against symptomatic Omicron at the same time points. This is where booster doses come into the picture. Theyre important to keep the immune system ready to fight off the virus, particularly for those who are more vulnerable to the effects of a COVID infection. Plus, regular booster doses can provide immunity against different variants. COVID vaccines are constantly beingreviewed and updatedto ensure optimal protection againstcurrent circulating strains, with the latest shot available designed to targetthe Omicron variant XBB 1.5. This is similar to how we approach seasonal flu vaccines. Arecent studyshowed a COVID vaccination provides longer protection against reinfection than natural protection alone. The median time from infection to reinfection in non-vaccinated people was only six months, compared with 14 months in people who had received one, two or three doses of vaccine after their first infection. This is calledhybrid immunity, and other research has similarly found it provides better protection than natural infection alone. It also seems timing is important, as receiving a vaccine too soon after an infection (less than six months) appears to beless effectivethan getting vaccinated later. What now? Everyones immune system is slightly unique, and SARS-CoV-2 continues to mutate, so knowing exactly how long COVID immunity lasts is complicated. Evidence suggests immunity following infection should generally last six months in healthy adults and can be prolonged with vaccination. But there are exceptions, and all of this assumes the virus has not mutated so much that it escapes our immune response. While many people feel the COVID pandemic is over, its important we dont forget the lessons we have learned. Practices such as wearing a mask and staying home when unwell can reduce the spread of many viruses, not onlyCOVID. Vaccination is not mandatory, but for older adults eligible for a booster under thecurrent guidelines, its a very good idea. Log in below to join the conversation. First published inThe Conversation. Read theoriginal article.
COVID-19 immunity SARS-CoV-2 vaccination
Pfizer-BioNTechs COVID-19 vaccine was highly effective in preventing severe COVID-19 infections in children and adolescents during the Delta and Omicron variants, according to a large, national study recently published in the Annals of Internal Medicine.
According to the Centers for Disease Control and Prevention, more than 15.6 million U.S. children were reported to have tested positive for COVID-19 since the onset of the pandemic and the age group represents less than 1 percent of total COVID-19 deaths.
Vaccination rates among children vary widely by state, according to the American Academy of Pediatrics, ranging from 3 to 45 percent having received their first dose.
The new study included data from more than 200,000 young people from childrens hospitals around the country during the Delta and Omicron waves of the pandemic. During the Delta wave, the BNT162b2 vaccine was found to be more than 98 percent effective against infection in children under 18 compared to those who were unvaccinated, according to the study. During Omicron, effectiveness against documented infection among children was estimated to be 74 percent compared to unvaccinated counterparts.
The BNT162b2 vaccine was most effective in preventing severe COVID-19 infections and hospitalizations, according to the study. Investigators found no significant side effects of the vaccine, but did find that vaccine effectiveness waned over time, especially during the Omicron period of the pandemic.
The results show that the BNT162b2 vaccine was a safe and effective way to prevent COVID-19 and the complications that can come with a serious infection, said Ravi Jhaveri, MD, division chief and the Virginia H. Rogers Professor of Infectious Disease in the Department of Pediatrics, who was a co-author of the study.
The main takeaway is an important result that comes up in virtually every study thats done on this: vaccination has a really powerful protective effect against COVID-19, Jhaveri said. There may be subtle differences depending on what variant and what era youre looking at, but the bottom line is that for children, theres a really powerful effect.
Moving forward, Jhaveri hopes to study the effectiveness of vaccines in preventing long COVID in children, he said.
What we want to do is to better define the protective effects of vaccines for post-COVID syndromes, including the long COVID fatigue and the multi-system, inflammatory syndrome that we saw in children, Jhaveri said. Were really working hard to try to see if we can show that the vaccine protects against those sequelae.
The study was funded by the National Institutes of Health and the RECOVER: Researching COVID to Enhance Recovery initiative.
In a recent study published in the journal JAMA Pediatrics, researchers carried out a large cohort study to investigate the association, if any, between in-utero exposure to COVID-19 vaccination and subsequent neurodevelopmental delay in infants. The cohort comprised 2,261 and 1,940 babies ages 12 and 18 months, respectively, with the Ages and Stages Questionnaire used to assess neurodevelopment rates across five parameters. Mixed-effects logistic modeling of results failed to find significant differences between observed and expected neurodevelopmental rates, highlighting the safety of COVID-19 vaccines administered during pregnancy on the neurological health of offspring.
Study:In Utero Exposure to Maternal COVID-19 Vaccination and Offspring Neurodevelopment at 12 and 18 Months.Image Credit:Prostock-studio/ Shutterstock
The coronavirus disease 2019 (COVID-19) pandemic represents an unprecedented loss of human life and economic collapse. Since its emergence in Wuhan, China, in late 2019, the virus has been responsible for a death toll of nearly 7 million, with more than 700 million individuals infected thus far. The medical and scientific panic induced by the pandemic spurned intensive research for a means to combat the disease, either by curing it or preventing its acquisition/transmission, resulting in the rapid development of anti-viral vaccines against the conditions causative pathogen the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Despite extensive fast-track preclinical trials of prospective vaccines, a focal risk group, namely pregnant women, was excluded from large-scale clinical trials due to mounting concerns over the negative impacts of vaccines on mothers and their to-be offspring. Even now, following the acute pandemic phase, little literature is available on the outcomes of during-pregnancy vaccinations for the next generation.
Sources of vaccine hesitancy include unknown risks to the fetus. Although a popular concern linking childhood vaccination and risk of autism spectrum disorder has been debunked, misinformation persists.
A popular argument against maternal vaccination is potential developmental issues with their offspring, with neurodevelopmental disorders the most often cited. Historically, vaccinations against influenza and rubella have been observed to have long-term, often life-long, adverse impacts on the neurological and psychiatric health of individuals with in-utero exposure. The trickle-down effect of this vaccine hesitancy is arguably the most significant factor in the dearth of knowledge and overabundance of misinformation regarding vaccination reception during pregnancies.
Despite being poorly studied in the context of COVID-19 vaccinations, neurodevelopmental disorders have been well-characterized. The term refers to a cohort of behaviorally defined conditions typically characterized by the early emergence of cognitive, language, motor, or social development abnormalities.
A range of genetic and environmental factors may underlie neurodevelopmental disorders, and fetal exposure to maternal inflammation represents a potential source of risk that has found increasing support from converging lines of epidemiologic and animal model evidence.
In the present study, researchers used data from a large prospective study representative of the United States of America (US) and Puerto Rico, comprising 2,487 mothers and 4,201 infants. Methodologies and outcomes are reported using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines. Participant recruitment was conducted between May 2020 and August 2021 and initially comprised 7,880 individuals. Study inclusion criteria included age (above 18 years) and questionnaire completion status.
Data collection comprised demographics (including self-reported ethnicity), medical history (including SARS-CoV-2 infection status), vaccination status (including type of vaccine received and number of booster doses), and three questionnaires. The Ages and Stages Questionnaire, third edition (ASQ-3), was used to measure the infants outcomes of interest five parameters encompassing the five neurodevelopmental subdomains: 1. Communication, 2. Fine motor, 3. Gross motor, 4. Social-, and 5. Problem-solving skills. The Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) questionnaires were used to measure maternal outcomes.
Vaccination, either with mRNA vaccines or viral-vector vaccines, was considered the study exposure. Mixed-effects logistic regression models constituted statistical analyses and were used to reveal the relationship between vaccination and subsequent neurodevelopment.
Of the 7,780 participants who initially enrolled in the study, 2,487 met the inclusion criteria and were included in the analyses. Most participants identified as White (89.3%) with a mean age of 33 years. 68% of participants reported receiving vaccinations during their pregnancy, 76.2% of which were mRNA vaccinations.
Notably, this study could not reveal any association between in-utero COVID-19 vaccine exposure and subsequent adverse neurodevelopment (stunted or delayed) outcomes. Encouragingly, neither offspring nor their mothers were found to experience any unexpected neurological outcomes, even when adjusting models to account for demographics and medical histories. SARS-CoV-2 infection status was also observed to have no significant bearing on the rate of neurodevelopment.
These findings highlight the importance of ongoing extensive prospective studies, especially in newborns and infants, to improve real-time mother and child care.
As our basic science colleagues tease out the dynamic mechanistic underpinnings of in-utero exposures, together we can transform these early data into knowledge to promote the health and well-being of our communities.
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