COVID-19 Vaccine Boosters for Young Adults: A Risk-Benefit Assessment and Five Ethical Arguments against Mandates at Universities

Authors: Kevin Bardosh University of Washington; University of Edinburgh – Edinburgh Medical School Allison Krug Artemis Biomedical Communications LLC Euzebiusz Jamrozik University of Oxford Trudo Lemmens University of Toronto – Faculty of Law Salmaan KeshavjeeHarvard University – Harvard Medical School Vinay Prasad University of California, San Francisco (UCSF) Martin A. Makary Johns Hopkins University – Department of Surgery Stefan Baral John Hopkins University Tracy Beth Høeg Florida Department of Health; Sierra Nevada Memorial HospitalDate Written: August 31, 2022

Abstract

Students at North American universities risk disenrollment due to third dose COVID-19 vaccine mandates. We present a risk-benefit assessment of boosters in this age group and provide five ethical arguments against mandates. We estimate that 22,000 – 30,000 previously uninfected adults aged 18-29 must be boosted with an mRNA vaccine to prevent one COVID-19 hospitalisation. Using CDC and sponsor-reported adverse event data, we find that booster mandates may cause a net expected harm: per COVID-19 hospitalisation prevented in previously uninfected young adults, we anticipate 18 to 98 serious adverse events, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity which interferes with daily activities. Given the high prevalence of post-infection immunity, this risk-benefit profile is even less favourable. University booster mandates are unethical because: 1) no formal risk-benefit assessment exists for this age group; 2) vaccine mandates may result in a net expected harm to individual young people; 3) mandates are not proportionate: expected harms are not outweighed by public health benefits given the modest and transient effectiveness of vaccines against transmission; 4) US mandates violate the reciprocity principle because rare serious vaccine-related harms will not be reliably compensated due to gaps in current vaccine injury schemes; and 5) mandates create wider social harms. We consider counter-arguments such as a desire for socialisation and safety and show that such arguments lack scientific and/or ethical support. Finally, we discuss the relevance of our analysis for current 2-dose CCOVIDovid-19 vaccine mandates in North America.

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https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID4206070_code5055014.pdf?abstractid=4206070&mirid=1

UK Bans COVID Vax for Kids – Investigation Finds Vaccine Affects Sexual Development in Little Boys

Authors:  Jim Hoft September 7, 2022 Gateway Pundit

The UK Health Security Agency banned the COVID vaccine from childrenwho had not turned five by the end of last month. The UK will no longer offer the vaccine to children aged 5 to 11.

Wolf also discussed a recent investigation that revealed the devastating affects of the vaccine on little boys. According to Dr. Naomi Wolf, the vaccine is hindering the development of the testes of pre-adolescent boys. This is a catastrophe.

The vaccines hurt the testes and hurt the parts of the testes that develop the masculinity and secondary sex characteristics of little boys, and baby boys, and teenage boys. So they literally harm the chances of your little boy child to grow up normally as a male human adult.

Study: Kids with COVID more likely to develop blood clots

Authors: David Olsen August 6, 2022 Newsday

Children who test positive for COVID-19 are much more likely to develop blood clots and cardiac problems weeks after their infection, compared with kids who did not contract the virus, a newly released study found.

The study, published Thursday by the Centers for Disease Control and Prevention, also found significantly higher rates of kidney failure and diabetes in those infected with the virus.

“A lot of the things they’re reporting are things that we’re seeing,” said Dr. Howard Balbi, chief of pediatric infectious diseases at Good Samaritan Hospital in West Islip.

Many of the kids who develop complications a few weeks after infection, including some who ended up in intensive care, initially had mild or no COVID-19 symptoms, he said.

WHAT TO KNOW

  • Children who tested positive for the coronavirus were significantly more likely to develop blood clots, cardiac problems, kidney failure and diabetes than kids who did not, a newly released CDC study found.
  • Long Island doctors said the study backs up what they’ve been seeing in hospitals. Many of the children who later developed complications initially had only mild COVID-19 or no symptoms at all, one pediatrician said.
  • Even though children are less likely to get severe COVID-19 than adults, the study shows that a small number of kids will develop serious health conditions, doctors say.

Dr. Andrew Handel, a pediatric infectious disease specialist at Stony Brook Children’s Hospital, said the study’s results “confirm our suspicions.”

“We know that most children who get COVID do not have severe infections from it,” he said. “But a small portion of these children are going to go on to have permanent organ damage as a result of the infection.”

The study is the largest ever in the United States on “post-COVID-19” effects on children, defined as symptoms and conditions four or more weeks after infection. CDC researchers examined medical records of more than 3.1 million children and adolescents, from infants to 17-year-olds, a quarter of whom had tested positive for the coronavirus and the rest who had not. The children were followed for between 60 days and a year.

Kids who had COVID-19 were twice as likely to have blood clots or lung-artery blockages caused by blood clots. They also were twice as likely to have cardiomyopathy, a disease of the heart muscle, or myocarditis, an inflammation of the heart muscle.

Last year, the CDC warned of rare cases of myocarditis among adolescent and young-adult males who received the Pfizer-BioNTech and Moderna vaccines. Some parents interviewed by Newsday and other media outlets said fear of myocarditis was a factor in not getting their children vaccinated.

But a CDC study released in April found that COVID-19 is far more likely than coronavirus vaccines to cause myocarditis, even among young males. The new study reiterates that COVID-19 is a greater myocarditis threat, Handel said.

In addition, he said, “What we’ve seen anecdotally in clinic [at Stony Brook] but also in research itself is that the myocarditis that kids get from the vaccine tends to be much, much, much less severe than when they experience it as a result of the infection itself. Generally, when kids get myocarditis after getting vaccinated, they can have some mild symptoms that usually just resolve on their own within a day or two. But myocarditis that you get with COVID infection itself can be devastating.”

COVID-19 causes inflammation, so it’s not surprising that the inflammation can continue for a longer period of time in some kids, said Dr. Mundeep Kainth, a pediatric infectious disease specialist at Cohen Children’s Medical Center in New Hyde Park.

“There is definitely already a known risk for that for anybody with COVID,” she said.

Children with COVID-19 also were about 1.3 times more likely to have kidney failure and roughly 1.2 times more likely to develop type 1 or type 2 diabetes or have issues with taste or smell, the study found.

The rate of malaise and fatigue among kids who had COVID-19 was only 1.05 times higher.

Studies have found that fatigue is the most common symptom of adults with “long COVID,” which the CDC defines as symptoms lasting at least three months after first contracting the virus.

Handel said he’s not surprised the rates of fatigue among kids aren’t higher.

“The symptoms that go along with what we’re calling long COVID — fatigue, body aches, difficulty thinking and maybe some psychiatric symptoms — those are really much less common in children for reasons that we don’t quite understand,” he said.

Kainth said the lower rates of fatigue also are probably because kids in general are more active than adults on average, and less likely to be fatigued.

Even so, Balbi said, multiple parents have told him that even though their kids who had gotten infected may not have severe post-COVID symptoms, “To quote the parent, ‘They’re just not themselves four months later. … They’re not back to normal. They’re not as active, they’re not as interested in doing things.’ ”

Researchers cautioned that the study was not representative of the U.S. pediatric population. About 70% of the kids were enrolled in Medicaid managed care. In addition, the analysis was based on medical records — meaning the children in the study who did not contract the coronavirus “were seeking medical care,” Kainth said. “These were not completely healthy kids.”

If healthier children had been part of the study, there may have been an even larger gap between kids who had COVID-19 and those who had not, she said.

COVID-19 unlikely to cause birth defects, but doctors await fall births

Experts cautiously optimistic that virus doesn’t target fetus during first trimester.

Authors: MEREDITH WADMAN August 7. 2022 SCIENCE

When a pregnant woman gets sick, her doctors have two patients: the woman and her fetus. While obstetricians work to understand COVID-19’s impact on mothers-to-be (see main story, p. 606), they are also carefully tracking the virus’ impact on the fetus, acutely aware that other viruses, including Zika, cytomegalovirus (CMV), and rubella, can cause serious birth defects. Researchers are cautiously optimistic the same will not prove true with the new coronavirus.

A case study published last month demonstrated conclusively that fetuses can be infected late in pregnancy. But such infections appear to be “extremely rare,” says lead author Daniele De Luca, a critical care neonatologist at Paris Saclay University Hospitals AP-HP. Stanley Plotkin, a physician-scientist who invented the widely used rubella vaccine, notes: “This is not rubella.” The 1964 epidemic of that disease led to the births of tens of thousands of damaged babies in the United States.

It’s still too soon to be certain that fetuses won’t be damaged if they are infected during the sensitive first trimester, when tissues and organs take shape. But Carolyn Coyne, a virologist who studies placental infections at the University of Pittsburgh, is optimistic. “If [the virus] was a devastating pathogen causing fetal malformations early in pregnancy, we would have very clear cases from China,” which had the earliest surge of COVID-19 cases. Senior Chinese obstetricians contacted by Science said they had seen no cases of congenital anomalies but warned that numbers were too small to draw firm conclusions.

Plotkin notes rubella and CMV are commonly blood-borne, allowing those viruses to reach the placenta during the first trimester, before it is a fully formed barrier to viral invasion. “Although SARS-CoV-2 virus does occasionally get into the blood, it is not basically a [blood-borne] infection,” he says. “That’s important.”

In one study of nearly 700 pregnant women admitted to three New York hospitals for delivery, 71 babies born to infected moms were uninfected themselves. Another study published this month in eLife suggests the virus is unlikely to easily invade placental cells. Scientists led by Roberto Romero at the National Institute of Child Health and Human Development and Wayne State University found placental cells rarely simultaneously express a pair of molecules that the virus relies on to invade cells: ACE2, a membrane-bound receptor, and TMPRSS-2, an enzyme that activates the virus after it has bound ACE2. By contrast, they found that receptors for Zika and CMV are abundant on placental cells.

Still, a mother’s SARS-CoV-2 infection could affect her fetus’ growth. Researchers in the New York study also examined placentas from a subset of women and found clots in blood vessels on the fetal side of the placenta in nearly half—14 of 29—of COVID-19–infected mothers. Only 11% of placentas—12 out of 106—from uninfected moms had similar clots. Another study, by researchers at Northwestern University, found significantly more blood vessel injury and clots on the maternal side of the placenta in 15 of 16 infected women than in controls.

Blood clots could limit the oxygen and nutrients delivered to the fetus. These studies suggest the need to closely monitor fetal growth during the second half of a COVID-19–affected pregnancy, says Malavika Prabhu, a maternal and fetal medicine specialist at Weill Cornell Medicine and first author on the New York study.

Meanwhile, she and others await a wave of babies conceived early in the pandemic and due in the fall. “If you have COVID-19 at 8 weeks during embryonic development, what is the outcome for that baby? That’s data that needs time to gestate,” says Yalda Afshar, a high-risk obstetrician at Ronald Reagan University of California, Los Angeles, Medical Center.

Delta reinfection risk low among unvaccinated children

But scientists warn that the findings do not mean that children should not be vaccinated against COVID-19.

Authors: Heidi Ledford July 4, 2022 NATURE

Children and adolescents who had not been vaccinated against COVID-19 mounted a long-lasting immune response to infection with the Delta variant of the coronavirus SARS-CoV-2, according to a large study of Israeli health records1. The study, which has been published as a preprint on medRxiv, has not yet been peer reviewed.

A year and a half after an infection, the resulting immune response was still about 80% effective at preventing reinfection, the study found. But it isn’t clear how the results will translate to infections by coronavirus variants of the Omicron lineage, which is now dominant in many countries. “There is a much less-robust immune response to Omicron among previously infected and/or vaccinated individuals,” says Yvonne Maldonado, chief of paediatric infectious diseases at Stanford School of Medicine in California. “Such immune responses are also significantly less durable.”

Even so, the study — which includes data from about 300,000 children and adolescents — is a welcome addition to the relatively small pool of knowledge about immune responses to SARS-CoV-2 in children, says paediatrician Nigel Crawford at the Murdoch Children’s Research Institute in Melbourne, Australia, who studies vaccinology. “They’re a group for which we haven’t seen a huge amount of data to date,” he says.

When Delta dominated

The study’s authors collected data on coronavirus infections from Maccabi Healthcare Services, an Israeli health-insurance plan. They focused on the risk of infection from 1 July to 13 December 2021, when the Delta variant was dominant in Israel.

The team found that unvaccinated children and adolescents were 89% less likely to be infected with SARS-CoV-2 3–6 months after their first infection than were children who had not previously been infected. For the 12–18 age group, this protection against reinfection dropped to 82.5% from 9 months to a year after infection and remained at around that level until up to 18 months post-infection.

Children aged 5–11, however, maintained the same level of protection. That, says Crawford, could fit with observations that young children often experience milder COVID-19 than do adolescents and adults.

The study authors are now working to collect data on Omicron infections, but that analysis will be more difficult because many people in Israel switched from PCR tests to at-home rapid antigen testing in December 2021. This means that fewer positive test results have since been reported in electronic health records.

Overall, the study design is robust, says clinical data scientist Hossein Estiri at Harvard Medical School in Boston, Massachusetts. He notes that some Twitter users have picked up on the preprint and are touting it as evidence that children who have had SARS-CoV-2 infections do not need to be vaccinated. But Estiri says it’s not clear from the study how well protection from natural infection stacks up to that from vaccines, because the researchers did not include a head-to-head comparison. “This study doesn’t say that those children don’t need to be vaccinated.”

Don’t discount vaccines

And because severe COVID-19 is rare in children, the study could not make strong conclusions about protection from serious illness and hospitalization. “We know that a lot of vaccine efficacy is against severe disease,” he says.

In addition, Crawford notes that people who have both been vaccinated and had a SARS-CoV-2 infection often experience a super-charged immune response compared with those who have had only a vaccine or infection. “You wouldn’t want to rely purely on infection alone for immunity,” he says. “We have no idea what the next wave will bring.”

CDC Caught Using False Data To Recommend Kids’ COVID Vaccine

Authors: DYLAN HOUSMAN HEALTHCARE REPORTER June 27, 2022 Daily Caller

The Centers for Disease Control and Prevention (CDC) showcased highly misleading data about the risk of COVID-19 to kids when its expert vaccine advisers voted to recommend vaccines for children under five years old.

The agency featured a pre-print study ranking causes of death in children when it presented data to its Advisory Committee on Immunization Practices (ACIP) earlier this month, after which the committee voted to recommend kids aged six months through four years get vaccinated for COVID-19. The study claimed to show that COVID-19 was a leading cause of death for children in the United States during the coronavirus pandemic, but observers quickly pointed out major flaws in the data which rendered it misleading.

The paper ranks COVID-19 as a top six cause of death for age brackets from 0-19, including under one year old, 1-4 years old, 5-9 years old, 10-14 years old and 15-19 years old. It’s unclear why the authors include 18- and 19-year-olds in pediatric data. A majority of the researchers involved in the paper are from the United Kingdom, where the age of majority is 18 in most jurisdictions.

However, one misleading aspect of the paper, as first pointed out by covid-georgia.com, is that it ranks cumulative COVID-19 deaths alongside annual rates for other causes for death. For instance, in the 1-4 age group, the paper ranks cumulative COVID-19 deaths as the 5th leading cause of death, ahead of heart disease and influenza. But further down the list, it ranks annual COVID-19 deaths in eighth. For every single age group, the cumulative COVID-19 death rate is more than double the annualized death rate.

Another big issue with the CDC data presentation is the conflation of deaths caused directly by COVID-19 versus those for which COVID-19 was just a “contributing” factor. The authors state “we only consider Covid-19 as an underlying (and not contributing) cause of death,” but that is false. 

The paper cites data from the National Center for Health Statistics (NCHS), which tabulates COVID-19 deaths by including any death certificate on which COVID-19 is mentioned, not just cases where it was the primary reason for death. The NCHS data cited by the researchers claims there have been 1,433 pediatric COVID-19 deaths through April 30, 2022. However, the CDC’s own data, which counts only deaths where the virus was the underlying cause, reported 1,088 pediatric deaths during that time period. That’s nearly 25% lower.

When the data is annualized and only includes deaths where the virus was the underlying cause, COVID-19 does not rank as a leading cause of death for young children. For kids under one year old, it ranks 9th, behind influenza and pneumonia, heart disease and homicide. Accidents are about 25 times as likely to kill an infant than COVID-19, according to the CDC data.

Among kids aged 1-4 and 5-9, COVID-19 ranked in a four-way tie for the 8th leading cause of death. For ages 10-14 it ranked in a two-way tie for 8th. For teenagers between 15 and 19 years old, it dropped in the cause of death ranking from 4th to 6th.

The CDC did not respond to multiple requests for comment when asked why it presented this misleading data and how that study made it though the agency’s rigorous review process. The FDA did respond after multiple attempts at contact, stating that “FDA speakers in the June 14-15th meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not cite the study in question in their presentations. FDA’s press release announcing the authorizations explains the basis for our determinations.”

One author of the study, Dr. Seth Flaxman, a computer science professor at the Imperial College of London, tweeted after the flaws in the paper were brought to light that the team is working on a revised version to be shared soon. At the time of publication for this article, the revised study did not yet appear to be available. Flaxman did not respond to a request for comment.

The false numbers were parroted by a number of mainstream sources. The data was tweeted out by Trump-era Surgeon General Jerome Adams and former Planned Parenthood president turned CNN medical commentator Leana Wen. However, it was also criticized by a number of healthcare professionals, including Dr. Vinay Prasad.

Still, the CDC continues to recommend getting vaccinated for all American children older than six months.

CDC recommends COVID-19 vaccines for babies, kids under 5. Here are 6 things parents need to know

The CDC says that parents may vaccinate very young children against coronavirus but what should they know first?

  Authors:  Dr. Marty Makary  | Fox News June 24, 2022

On Saturday, CDC Director Rochelle Walensky announced a new recommendation to vaccinate all 20 million children 6 months to 5 years of age. Here are some things left out of the announcement that parents should know.

1. The research was inconclusive

The studies were too small to achieve statistical significance when evaluating efficacy against mild or severe COVID-19 infection. As a result, the FDA allowed both companies to extrapolate effectiveness by measuring antibody levels, pointing to data from older children and adults.

There were no cases of severe COVID illness in either the vaccine or placebo group. The Moderna vaccine had 4,774 children and the Pfizer vaccine had 4,526 (including those who received the placebo).

Pfizer concluded that their vaccine was 80% effective in preventing symptomatic COVID-19, but based it on 3 cases in the vaccine group and 7 cases in the placebo group in a subset of children who received a third dose. 

Even this was not statistically significant. In fact, it had a confidence statistic so wide, you could drive an aircraft carrier through it. (They reported the largest confidence interval I have ever seen in my 20-year research career). At one end of the range of possibilities indicated by the confidence interval, the vaccine could be associated with a 370% increased risk of getting COVID-19. The Moderna trial reported a short-term efficacy of 38% in preventing symptomatic illness–an effect well-known to be transient.

Ironically, there were more overall hospitalizations (unspecified) in the vaccine group. Out of a total of 7 children requiring hospitalization, 6 were in the vaccine group and 1 was in the placebo group, which was half as large. 

The CDC even said in its own slides at their deliberation meeting that data assessing efficacy were poor, characterizing them as “very low certainty” and noting that there are “very serious concerns for imprecision due to study size”. They also noted the very short follow-up time of 1.3 months.

2. The FDA lowered their standards for acceptable vaccine efficacy needed to approve

In 2020, the FDA and public health officials said they would authorize a COVID vaccine that showed at least a 50% efficacy. But weeks before the vaccines were authorized for babies and toddlers, the FDA’s Dr. Peter Marks lowered the pre-set bar, saying on May 6, “If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize.”

There is absolutely zero clinical evidence to support vaccinating healthy children who already had COVID. Natural immunity, inexplicably ignored by public health officials, confers strong protection against severe disease.

3. Most children have natural immunity

The CDC reported reported that, as of February 2022, 75% of children 0-17 years-old already had COVID-19. Given how rampant the Omicron strain has circulated since then, upwards of 80-90% of children have likely had COVID-19. There is absolutely zero clinical evidence to support vaccinating healthy children who already had COVID. Natural immunity, inexplicably ignored by public health officials, confers strong protection against severe disease.

4. Safety was based on a small sample 

 The small size of the studies in children under 5 makes it nearly impossible to observe rates of rare complications such as myocarditis, which occurs in 1 in 2,650 12-17 year-old boys after the 2nd dose. This complication has been associated with EKG changes in children and even concerning MRI findings months after recovering from myocarditis. 

The New England Journal of Medicine reported one case of vaccine-associated myocarditis death in a 22-year-old in an Israeli population study. Keep in mind that babies can’t tell you when they have myocarditis.

Each of the Moderna and Pfizer COVID studies in children under 5 reported one serious adverse event after receiving the vaccine. Less serious adverse events (pain, swelling, local reactions) were similar across the vaccine and placebo groups (7.7% vs 4.1% for Moderna; 1% vs 1.5% for Pfizer). These data do suggest a good safety profile, likely due to the low dose given. However, time will tell. 

As Dr. Eric Rubin, the editor-in-chief of the New England Journal of Medicine, said in October 2021, “But we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes.” 

Establishing safety takes time. The infant rotavirus vaccine, Rotashield, was first thought to be safe. In the original trial, the adverse event (an intestinal malfunction requiring surgery) had been noted in 5 of 10,054 vaccine recipients, but the side effect was not deemed statistically significant. Ultimately, that vaccine was pulled from the market after many more complications were observed. Similarly, J&J’s vaccine was bannered to be safe until the FDA said otherwise.

By comparison, the polio vaccine was tested in 1.8 million children over a year before it was broadly recommended.

5. Healthy children have a very low risk of a serious consequence from COVID-19

Healthy children have a radically different risk profile and a different need for vaccination compared to children with comorbid conditions.  A German population study found that all deaths in children 5-17 were in children with a comorbidity.  That is, no healthy child 5-17 died in that country unvaccinated. 

Alasdair Munro analyzed UK data and determined that 75% of deaths of children from COVID in the UK occurred in the 8% of children who have other serious health issues. That’s why the risk-benefit ratio is radically different for a child with comorbidity than a healthy child.

The CDC’s risk analysis lumps all children together. It also makes the mistake of counting hospitalizations and death where COVID was an incidental finding. An NHS report found that up to 68% of COVID hospitalization are not “for” COVID.

For children with a medical condition such as diabetes or immune suppression, I would recommend COVID vaccination with two doses 8 to 12 weeks apart, if the child does not already have natural immunity. The case to vaccinate healthy children is not compelling. 

6. CDC’s announcement lacked humility

On Saturday, a beaming Dr. Walensky said “We now know based on rigorous scientific review that the vaccines….can be used safely and effectively in children under 5.” The review might have been rigorous, but the underlying data was not.

A more appropriate announcement would have been “We approved the COVID vaccine for babies and toddlers based on very little data. While we believe it is safe in this age group, the study size was too low to make a definitive conclusion about safety. Moreover, the studies were conducted in children who did not have COVID previously.”

Less absolutism and more humility by public health officials would go a long way in rebuilding public trust. Not surprisingly, only 18% of parents said they were planning give the COVID vaccine to their child under five anytime soon.

Diabetes may increase long COVID risk; COVID while pregnant linked to baby brain development issues

Authors: Nancy Lapid Thu, June 9, 2022,

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

Diabetes may increase the risk of long COVID, new analyses of seven previous studies suggest.

Researchers reviewed studies that tracked people for at least four weeks after COVID-19 recovery to see which individuals developed persistent symptoms associated with long COVID such as brain fog, skin conditions, depression, and shortness of breath. In three of the studies, people with diabetes were up to four times more likely to develop long COVID compared to people without diabetes, according to a presentation https://eppro02.ativ.me/web/page.php?page=IntHtml&project=ADA22&id=1683 on Sunday at the annual Scientific Sessions of the American Diabetes Association. The researchers said diabetes appears to be “a potent risk factor” for long COVID but their findings are preliminary because the studies used different methods, definitions of long COVID, and follow-up times, and some looked at hospitalized patients while others focused on people with milder cases of COVID-19.

“More high-quality studies across multiple populations and settings are needed to determine if diabetes is indeed a risk factor” for long COVID, the researchers said. “In the meantime, careful monitoring of people with diabetes… may be advised” after COVID-19.

COVID-19 in pregnancy linked with babies’ learning skills

Babies born to mothers who had COVID-19 while pregnant may be at higher than average risk for problems with brain development involved in learning, focusing, remembering, and developing social skills, researchers have found.

They studied 7,772 infants delivered in Massachusetts between March and September 2020, tracking the babies until age 12 months. During that time, 14.4% of the babies born to the 222 women with a positive coronavirus test during pregnancy were diagnosed with a neurodevelopmental disorder, compared to 8.7% of babies whose mothers avoided the virus while pregnant. After accounting for other neurodevelopmental risk factors, including preterm delivery, SARS-CoV-2 infection during pregnancy was linked with an 86% higher risk of a neurodevelopmental disorder diagnosis in offspring, the researchers reported on Thursday in JAMA Network Open https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793178. The risk was more than doubled when the infection occurred in the third trimester.

The researchers point out that their study was brief and cannot rule out the possibility that additional neurodevelopmental effects will become apparent as the children grow up. On the other hand, they note, larger and more rigorous studies are needed to rule out other potential causes and prove that the coronavirus is to blame.

The rare but life-threatening inflammatory syndrome seen in some children after a coronavirus infection has become even more rare with the Omicron variant causing most infections and more kids vaccinated, according to a new study.

Researchers looked at data from Denmark on more than half a million children and adolescents infected after Omicron became dominant, about half of whom experienced breakthrough infections after vaccination. Overall, only one vaccinated child and 11 unvaccinated children developed Multisystem Inflammatory Syndrome in Children (MIS-C), which causes inflammation in the heart, lungs, kidneys and brain after a mild or asymptomatic SARS-CoV-2 infection. That translates to rates of 34.9 MIS-C cases per million unvaccinated children with COVID-19 and 3.7 cases per million vaccinated young COVID-19 patients, the researchers said on Wednesday in JAMA Pediatrics https://jamanetwork.com/journals/jamapediatrics/fullarticle/2793024. By comparison, rates of MIS-C cases when Delta was predominant were 290.7 per million unvaccinated infected kids and 101.5 per million among the vaccinated who had COVID, they said.

The fact that MIS-C risk was significantly lower in vaccinated children suggests the vaccine is helping to keep the immune system from causing the deadly inflammatory reaction that is an MIS-C hallmark, the researchers said.

Association of COVID-19 Vaccination During Pregnancy With Incidence of SARS-CoV-2 Infection in Infants

Authors: Ellen Øen Carlsen, MD1Maria C. Magnus, PhD1Laura Oakley, PhD1,2et alDeshayne B. Fell, PhD3,4Margrethe Greve-Isdahl, MD5Jonas Minet Kinge, PhD1,6Siri E. Håberg, MD, PhD

JAMA Intern Med. Published online June 1, 2022. doi:10.1001/jamainternmed.2022.2442

Key Points

Question  Is maternal COVID-19 vaccination during the second or third trimester of pregnancy associated with reduced risk of COVID-19 within the first 4 months of life in their infants?

Findings  In this register-based cohort study of all live-born infants in Norway, there was a lower incidence of a positive SARS-CoV-2 test result in infants born to women vaccinated with a messenger RNA vaccine during pregnancy. The risk was lower during the period dominated by the Delta variant than during the Omicron-dominated period.

Meaning  The study results suggest that maternal COVID-19 vaccination during pregnancy could protect against infant SARS-CoV-2 infection in the early months of life.

Abstract

Importance  Pregnant women are recommended to receive COVID-19 vaccination to reduce risk of severe COVID-19. Whether vaccination during pregnancy also provides passive protection to infants after birth remains unclear.

Objective  To determine whether COVID-19 vaccination in pregnancy was associated with reduced risk of COVID-19 in infants up to age 4 months during COVID-19 pandemic periods dominated by Delta and Omicron variants.

Design, Setting, and Participants  This nationwide, register-based cohort study included all live-born infants born in Norway between September 1, 2021, and February 28, 2022.

Exposures  Maternal messenger RNA COVID-19 vaccination during second or third trimester compared with no vaccination before or during pregnancy.

Main Outcomes and Measures  The risk of a positive polymerase chain reaction test result for SARS-CoV-2 during an infant’s first 4 months of life by maternal vaccination status during pregnancy with either dose 2 or 3 was estimated, as stratified by periods dominated by the Delta variant (between September 1 and December 31, 2021) or Omicron variant (after January 1, 2022, to the end of follow-up on April 4, 2022). A Cox proportional hazard regression was used, adjusting for maternal age, parity, education, maternal country of birth, and county of residence.

Results  Of 21 643 live-born infants, 9739 (45.0%) were born to women who received a second or third dose of a COVID-19 vaccine during pregnancy. The first 4 months of life incidence rate of a positive test for SARS-CoV-2 was 5.8 per 10 000 follow-up days. Infants of mothers vaccinated during pregnancy had a lower risk of a positive test compared with infants of unvaccinated mothers and lower risk during the Delta variant–dominated period (incidence rate, 1.2 vs 3.0 per 10 000 follow-up days; adjusted hazard ratio, 0.29; 95% CI, 0.19-0.46) compared with the Omicron period (incidence rate, 7.0 vs 10.9 per 10 000 follow-up days; adjusted hazard ratio, 0.67; 95% CI, 0.57-0.79).

Conclusions and Relevance  The results of this Norwegian population-based cohort study suggested a lower risk of a positive test for SARS-CoV-2 during the first 4 months of life among infants born to mothers who were vaccinated during pregnancy. Maternal COVID-19 vaccination may provide passive protection to young infants, for whom COVID-19 vaccines are currently not available.

Introduction

The risk of critical illness because of COVID-19 has been reported to be higher in infants younger than 1 year compared with older children.1 To our knowledge, no COVID-19 vaccines are currently available for infants or children younger than 5 years. Transplacental transfer of maternal vaccine-derived antibodies against pertussis and seasonal influenza has been demonstrated following vaccination during pregnancy, and maternal immunization provides passive protection against infection to infants during the first months after birth.2,3 It is plausible that COVID-19 vaccination during pregnancy could provide passive protection from COVID-19 to infants during their first months of life.4 Vaccine-derived maternal antibodies have been identified in cord blood after COVID-19 vaccination during pregnancy, and a recent study found maternal vaccination to be associated with a 61% reduced risk of infant hospitalization for COVID-19.57 This study evaluated the association between maternal COVID-19 vaccination during pregnancy and incidence of infant SARS-CoV-2 infection during the first 4 months of life, as well as whether the association differed according to Delta variant and Omicron variant–dominated time periods.811

Methods

Study Population and Data Sources

All live births in Norway between September 1, 2021, and February 28, 2022, were identified in the Medical Birth Registry of Norway (Figure 1),12 which captures all pregnancies ending after completion of gestational week 12. Newborns were excluded if the mother or infant did not have a permanent national identification number, which was used to link information across registries.

All data used in this study were provided by the Emergency Preparedness Register for COVID-19 (Beredt C19),13 which is run by the Norwegian Institute of Public Health. This register was established in response to the COVID-19 pandemic in 2020 in accordance with the Health Preparedness Act §2-4 and contains daily updated data from the Norwegian health registries.

COVID-19 Vaccination During Pregnancy

The Norwegian Immunization Register14 contains registrations of all COVID-19 vaccinations, including dates of all doses and the type of vaccine product. Vaccine doses reported fewer than 20 days after the previous dose were not included. Women who received a second or third dose of a messenger RNA (mRNA) vaccine after gestational day 83 and up to 14 days before delivery were considered vaccinated. Infants born to women who received their third or fourth vaccine dose between 13 and 7 days before birth were excluded, as they would be censored before birth in the statistical analyses. We excluded infants born to women vaccinated outside Norway while pregnant and those vaccinated exclusively before pregnancy or who only received dose 1 during pregnancy because the maternal antibody level and possible transplacental transfer of antibodies for these scenarios are uncertain.1517

SARS-CoV-2 Infection

During the study period (September 1, 2021, to April 4, 2022), the date of testing and results of all SARS-CoV-2 polymerase chain reaction (PCR) tests were registered in the Norwegian Surveillance System for Communicable Diseases.18 We included the first positive PCR test for SARS-CoV-2 registered at least 1 day after birth and within 122 days after birth (4 months of age). Similarly, we identified women with a positive SARS-CoV-2 test 14 days or more before giving birth. In Norway, PCR tests were free of charge and widely available.

Covariates

From the Medical Birth Registry of Norway, we derived maternal age at conception (<24, 25-29, 30-34, 35-39, ≥40 years) and extracted information on parity (0, 1, or ≥2) and calendar week of birth. The registered gestational age in the birth registry was estimated from routine ultrasonography assessments or last menstrual period if there were no ultrasonography estimates. From the Population Registry of Norway, we obtained information on maternal country of birth (Scandinavian country [Norway, Denmark, and Sweden], or non-Scandinavian countries) and current county of residence (Oslo, Viken, or other Norwegian county). From Statistics Norway we obtained information on the highest maternal educational level as of 2019 (no higher education, higher education ≤4 years, >4 years of higher education, or missing).

Statistical Analysis

We calculated incidence rates of SARS-CoV-2 infection (number of infants with positive tests among all infants at risk at the day of testing) in infants within 4 months after birth by maternal vaccination status. We split the follow-up time on December 31, 2021, by introducing a variable with 2 categories that corresponded to the time before this date (proxy for the Delta-dominated period) and after this date (proxy for the Omicron-dominated period). Using a Cox proportional hazards model, we estimated hazard ratios (HRs) for infant SARS-CoV-2 infection using calendar time (in days) as the time axis. Infant follow-up began on the date of birth. Observations were censored at age 4 months, death or emigration, date of when a woman received a vaccine dose outside Norway, or on April 4, 2022, whichever came first. For women vaccinated at the end of pregnancy or after pregnancy, infants were censored 14 days after the vaccination date of dose 1 and 7 days after dose 3 or 4. This was done because maternal vaccination within the last 14 days of pregnancy could potentially provide an exclusive protective effect from antibody transfer through breastfeeding or cocooning (ie, immunizing primary caretakers).19,20

We assessed differences in the Delta and Omicron periods by using linear combinations of the coefficients for vaccination status and an interaction term between vaccination status and period. Multivariable analyses adjusted for maternal age at conception, parity, educational level, county of residence, and maternal country of birth.

Sensitivity Analyses

First, we excluded infants born to women who had a positive SARS-CoV-2 test more than 14 days before delivery, as women with a history of COVID-19 might be less likely to become vaccinated during pregnancy and could transfer anti–SARS-CoV-2 antibodies across the placenta.5 Second, in separate analyses, we restricted the sample to (1) term-born infants, (2) infants who had the opportunity to reach 42 completed gestational weeks by the end of the inclusion period to avoid oversampling preterm births, (3) infants born to Scandinavian-born women, (4) infants born to first-time mothers, and (5) infants born to women who only received mRNA vaccines for all doses. Third, to obtain more robust results for the Omicron-dominated period, we used an alternative follow-up period starting on January 15, 2022, as after this date the circulating virus was more certain to be Omicron. Finally, as testing and risk of infection may differ by infant age, we used infant age in days as the time axis, while adjusting for week of birth.

Secondary Analyses

Using the Norwegian Patient Registry,21 we explored the risk of infant hospitalization for COVID-19. All hospital admissions were registered with admission and discharge dates, as well as diagnostic codes, using the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10). We identified all infants with a hospitalization with the ICD-10 code U07.1 (COVID-19, virus identified) as the main diagnosis within the first 4 months of life and reported the crude proportions by maternal vaccination status.

To assess associations between maternal vaccination, even if not fully vaccinated, and incidence of a positive PCR test for SARS-CoV-2 among infants, we conducted a secondary analysis in which we compared the risk of a positive SARS-CoV-2 test in infants born to unvaccinated women with those with mothers who had received a first dose of an mRNA vaccine during the second or third trimester (these were excluded from the main analysis). Infants were censored 14 days after a woman received the second dose postpartum or during the last 14 days of pregnancy and 14 days after the first dose among the unvaccinated group. We compared the timing of vaccination in pregnancy in those who received only 1 dose in pregnancy with those who were fully vaccinated. Furthermore, we conducted a secondary analysis stratifying on whether the woman received COVID-19 vaccine dose number 2 or 3 during pregnancy.

To explore possible differences in the likelihood of being tested in infants among vaccinated and unvaccinated mothers, we assessed the proportions in each group that had at least 1 registered SARS-CoV-2 PCR test (positive or negative) before age 4 months. We calculated crude incidence rates for registration of a PCR test by maternal vaccination status. Again, infants were censored at time of death, emigration, or maternal receipt of a vaccine dose outside Norway. All analyses were conducted using Stata, version 16.0 SE (StataCorp).

Results

Of 21 643 newborns included in the study, 9739 (45%) were born to women who received a second or third dose of a COVID-19 mRNA vaccine during the last 2 trimesters of pregnancy (Table 1). Fewer than 5 women received a fourth dose in pregnancy. Compared with vaccinated mothers, unvaccinated mothers were younger, had higher parity and lower education, and fewer were born in Scandinavia. The proportion of infants born to a vaccinated mother increased during the study period (eFigure 1A in the Supplement). Most newborns with a positive SARS-CoV-2 test during the fall of 2021 were born to unvaccinated mothers (eFigure 1B in the Supplement), but an infant’s age at the time of a positive test was similar between the groups (eFigure 1C in the Supplement). The number of tested infants decreased by mid-February 2022 (eFigure 1D in the Supplement).

Incidence of SARS-CoV-2 in Infants

A total of 906 infants (4.1%) were registered with a positive PCR test for SARS-CoV-2 during the first 4 months of life. Infants born to vaccinated mothers had a lower incidence of SARS-CoV-2 (Figure 2). During the Delta-dominated period (before January 1, 2022), crude incidence rates for a positive test were 1.2 per 10 000 follow-up days among infants born to vaccinated mothers and 3.0 per 10 000 follow-up days among infants born to unvaccinated mothers. The corresponding adjusted HR (aHR) for the Delta-dominated period was 0.29 (95% CI, 0.19-0.44) (Table 2). During the Omicron-dominated period (starting on January 1, 2022), the crude incidence rates for a positive SARS-CoV-2 test were 7.0 per 10 000 follow-up days among infants born to vaccinated mothers and 10.9 per 10 000 follow-up days among infants born to unvaccinated mothers (aHR, 0.67; 95% CI, 0.57-0.79) (Table 2). We observed no violation of the proportional hazard assumption.

Sensitivity Analyses

Results were robust in sensitivity analyses, although estimates were attenuated when restricting to infants born to Scandinavian-born women (eTables 1-6 in the Supplement). The results for the Omicron-dominated period when restricted to January 15 and later were similar to the main analyses (eTable 7 in the Supplement). Using the infant age as the time scale attenuated the association slightly (eTable 8 and eFigure 2 in the Supplement).

Secondary Analyses

The proportion of infants hospitalized with COVID-19 as the main diagnosis before age 4 months or April 4, 2022, was 0.07% in both groups. The numbers were too low to perform formal comparative analyses by maternal vaccination status (Table 1).

In addition to the 21 463 infants in the main analysis, 2839 infants were born to women who only received 1 dose of an mRNA vaccine during the second or third trimester of pregnancy and at least 14 days before delivery. The timing of vaccine doses was differentially distributed by calendar time and time interval before birth between those who received only 1 vs a second or third dose in pregnancy (eFigures 3 and 4 in the Supplement), and the mean follow-up time was shorter. Among those born to women who received 1 dose of vaccine, 36 infants had a positive SARS-CoV-2 PCR test, including fewer than 5 during the Delta-dominated period. The aHR for a positive test in infants during the Omicron-dominated period born to women with 1 dose of vaccine compared with infants born to unvaccinated women was 0.72 (95% CI, 0.50-1.03) (eTable 9 in the Supplement).

Among 824 infants born to women who received their third vaccine dose during pregnancy, none had a positive SARS-CoV-2 test during the Delta-dominated period. The risk of a positive test was lower for the Omicron-dominated period for those with a third dose (aHR, 0.22; 95% CI, 0.12-0.43) compared with those with a second dose (aHR, 0.70; 95% CI, 0.59-0.83) (eTable 10 in the Supplement).

The proportion of infants who had at least 1 PCR test for SARS-CoV-2 during follow-up differed by maternal vaccination status: 2309 infants (19.4%) born to unvaccinated mothers and 1206 infants (12.4%) born to vaccinated mothers (Table 1). Corresponding incidence rates were 19.7 per 10 000 follow-up days among infants born to unvaccinated women and 15.1 per 10 000 follow-up days among infants born to vaccinated women.

Discussion

This cohort study of all live births in Norway between September 1, 2021, and February 28, 2022, found that COVID-19 vaccination during pregnancy was associated with a reduced risk of an infant receiving a positive PCR test for SARS-CoV-2 during the first 4 months of life. This association was present during periods dominated by the Delta and Omicron variants, although it was stronger in the former. Results were robust in sensitivity analyses, although the number of cases during the Delta-dominated period was low in some of the subgroups. The association was somewhat attenuated when restricted to infants born to Scandinavian-born women.

It is not unexpected that maternal COVID-19 vaccination during pregnancy could reduce infant risk of COVID-19, as similar protective benefits against infant infection have been documented for pertussis and influenza vaccination during pregnancy in randomized clinical trials and observational studies.2,3 Because the newborn’s immune system is naive, with limited antibody response during the first months of life, an important protection against infection comes from maternally transferred antibodies.2,3 Infants are at higher risk of severe COVID-19 compared with older children.1 As to our knowledge no COVID-19 vaccines are licensed for use in children younger than 5 years, an added benefit of maternal vaccination during pregnancy could be a protection of infants against SARS-CoV-2 infection during the first months of life.4

We observed a lower risk of infection among infants born to women who received their third dose in pregnancy compared with the second, suggesting a stronger level of protection following the booster dose. This aligns with studies showing a waning of vaccine effect after the second dose unless a booster is received.11 Infants born to women with only 1 mRNA vaccine dose received during pregnancy also had a lower risk of a positive SARS-CoV-2 test than those born to unvaccinated women, but results were not statistically significant.

Strengths and Limitations

The strengths of this study include the use of registry data covering the whole Norwegian population and many individuals vaccinated during pregnancy. Mandatory reporting to registries (including all COVID-19 vaccinations) limited potential selection bias and provided detailed information on clinical and sociodemographic variables. We believe our study results are generalizable to other pregnant populations. This assumption is strengthened by the fact that the findings align with the results from the US study examining maternal COVID-19 vaccination and risk of infant hospitalization for COVID-19.6

The limitations of this study included the lack of information on the infant’s test with a SARS-CoV-2 variant. However, there were distinct periods of dominance with the different variants in Norway during the study period, and we believe the defined periods capture risk with the different variants. The differences we observed in estimates for the Delta and Omicron-dominated periods support this, as the vaccines generally have been shown to be less effective against Omicron than Delta.8,11

Although we did not include vaccinations during the last 14 days of pregnancy or after pregnancy in the vaccinated group to allow for sufficient time of transplacental transfer of antibodies before birth,22 there could be a possible added effect of transfer of SARS-CoV-2 antibodies through breastmilk in these children,23,24 as more than 90% of infants in Norway are breastfed.25,26 We did not have individual-level information on breastfeeding and were unable to directly address whether this differed by maternal vaccination status.

We adjusted for potential confounders, which did not substantially affect the estimates. Still, there may be residual confounding because of healthy vaccinee bias27 or other unmeasured differences in characteristics between women who got vaccinated during pregnancy and those who did not.

The distribution of follow-up time in the vaccinated and unvaccinated groups varied across the 2 periods. We used calendar time as the underlying time scale in the analyses to ensure that comparisons were made on the same calendar days. This was important, as maternal vaccination status and risk of SARS-CoV-2 infection varied substantially over the study period. Although we did not have information on the number of household members or positive SARS-CoV-2 tests among them, we adjusted for maternal parity as a proxy.

We did not have information on disease symptoms in the infants. Thus, we could not assess the severity of the infections and whether this differed by maternal vaccination status. As the number of infants hospitalized for COVID-19 was low, we could not perform robust analyses to discern whether this differed by maternal vaccination status. We found that infants born to unvaccinated women were more likely to be tested for SARS-CoV-2, and this could be because of higher incidence of COVID-19 or a higher likelihood of symptomatic disease leading to testing. Although we cannot exclude differential test behavior according to maternal vaccination status, we believe it is unlikely. However, women who got vaccinated may have behaved differently (ie, taking more or fewer precautions to limit infant infection risk), which could have biased the estimates. Still, this is unlikely to account for all of the substantial reduction in risk that we observed.

Conclusions

In this nationwide registry-based cohort study, we found that infants born to women who received a second or third COVID-19 vaccine dose during the last 2 trimesters of pregnancy had a lower incidence of SARS-CoV-2 infection within the first 4 months of life compared with infants born to unvaccinated women. The reduction in infant infection risk was greater during the Delta-dominated period compared with the Omicron-dominated period. The findings of this study provide early evidence to suggest that infants benefit from passive protection from SARS-CoV-2 infection following maternal COVID-19 vaccination during pregnancy.

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Dr. Robert Malone: ‘Rotten to the Core’ FDA Knew COVID Vaccines Could Spur Viral Reactivation, But Said Nothing

Authors:  Debra Heine May 17, 2022

American Greatness

The Food and Drug Administration (FDA) was aware early on that the COVID vaccines could spur viral reactivation of diseases like the varicella-zoster virus (shingles) in some people, but chose not to disclose it, according to renowned vaccinologist and physician Dr. Robert Malone.

“They knew about the viral reactivation,” Malone declared during a recent panel discussion hosted by Del Bigtree with fellow Global COVID Summit physicians Dr. Ryan Cole, and Dr. Richard Urso.

Malone, the original inventor of mRNA and DNA vaccination technology, explained that he had been “very actively engaged” with senior personnel at the FDA in the Office of the Commissioner when the vaccines were being rolled out. The group, he noted, included Dr. William DuMouchel, the Chief Statistical Scientist for Oracle Health Sciences.

“We were talking by Zoom on a weekly or twice a week basis,” he said, regarding the early data on what risks were associated with vaccines.

“This is the group that first discovered the signal of the cardiotoxicity, the doctor continued. “They also knew at that time—one of them actually had the adverse event early on of shingles. They knew that the viral reactivation signal—which the CDC has never acknowledged—was one of the major known adverse events.”

Malone told the panel that it was a mistake to assume that the CDC and FDA—because they stayed silent—were unaware of the risk of viral reactivation associated with the vaccines.

“They absolutely did know, and they did not acknowledge it. It’s another one of those things that is inexplicable,” he said.

Malone pointed out that there are supposed to be strict rules in place for clinical researchers developing “these types of products.”

“You have to characterize where it goes, how long it sticks around, and how much protein it makes, or what the active drug product is. None of that stuff was done very well. It wasn’t done rigorously, and there was a series of misrepresentations about what the data were,” he said. “And the thing is, the FDA let them get away with it. They did not perform their function. They’re supposed to be independent gatekeepers.”

Normally, he pointed out, the FDA pays close attention to the the process, and if there are any red flags, the research is halted.

“What happened here is the regulatory bodies gave the pharmaceutical industry a pass,” Dr. Malone said, adding that Big Pharma also “misrepresented key facts about their product.”

“On the basis of that, average docs just assumed that this was something that it wasn’t. They assumed that this was a relatively benign product that didn’t stick around in the body. All of that is false,” he said.

“Many of us have been wracking our brains as you have to understand how this could possibly happen, why it’s possibly happening, and why is our regulatory apparatus, which we as physicians had all come to assume had a function that actually did the job that we could believe in and trust, and what we find out now is the whole house of cards is rotten to the core,” Malone concluded.

On May 11, the Global COVID Summit, a symposium of 17,000 other physicians and medical scientists from around the world, released its fourth declaration demanding that the state of medical emergency be lifted, scientific integrity restored, and crimes against humanity addressed.

COVID policies imposed over the past two years “are the culmination of a corrupt medical alliance of pharmaceutical, insurance, and healthcare institutions, along with the financial trusts which control them,” the signatories declare. “They have infiltrated our medical system at every level, and are protected and supported by a parallel alliance of big tech, media, academics and government agencies who profited from this orchestrated catastrophe.”

This “corrupt alliance” continues, they state,  “to advance unscientific claims by censoring data, and intimidating and firing doctors and scientists for simply publishing actual clinical results or treating their patients with proven, life-saving medicine.”

“These catastrophic decisions came at the expense of the innocent, who are forced to suffer health damage and death caused by intentionally withholding critical and time-sensitive treatments, or as a result of coerced genetic therapy injections, which are neither safe nor effective,” the signatories said.

The Centers for Disease Control and Prevention (CDC) on Friday released new data showing a total of 1,261,149 reports of adverse events following COVID-19 vaccines that were submitted between Dec. 14, 2020, and May 6, 2022, to the Vaccine Adverse Event Reporting System (VAERS).

According to the data, there was a total of 27,968 reports of deaths in that time frame, and 228,477 serious injuries.

Despite these alarming safety signals, the FDA on Tuesday approved of a booster dose of the Pfizer-BioNTech COVID-19 shot for children 5 through 11 years of age, even though research shows that the shots provide no benefit to children, and can, in fact, cause serious adverse effects and death.