COVID-19 linked to increase in US pregnancy-related deaths

Authors: Amanda Seitz/APPosted: OCT 19, 2022 News Nation

WASHINGTON (AP) — COVID-19 drove a dramatic increase in the number of women who died from pregnancy or childbirth complications in the U.S. last year, a crisis that has disproportionately claimed Black and Hispanic women as victims, according to a government report released Wednesday.

The report lays out grim trends across the country for expectant mothers and their newborn babies.

It finds that pregnancy-related deaths have spiked nearly 80% since 2018, with COVID-19 being a factor in a quarter of the 1,178 deaths reported last year. The percentage of preterm and low birthweight babies also went up last year, after holding steady for years. More pregnant or postpartum women are also reporting symptoms of depression.

“We were already in the middle of a crisis with maternal mortality in our country,” said Karen Tabb Dina, a maternal health researcher at the University of Illinois at Urbana-Champaign. “This really shows that COVID-19 has exacerbated that crisis to rates that we, as a country, are not able to handle.”

The nonpartisan U.S. Government Accountability Office, which authored the report, analyzed pregnancy-related deaths after Congress mandated that it review maternal health outcomes in the 2020 coronavirus relief bill.

Florida Surgeon General Recommends Against mRNA COVID-19 Vaccines For Males Aged 18–39

Authors: Mimi Nguyen Ly via The Epoch Times, Ocyobrt 8, 2022

Florida’s Surgeon General, Dr. Joseph A. Ladapo, announced new guidance on messenger RNA (mRNA) vaccines on Friday, specifically recommending against mRNA COVID-19 vaccines for males aged 18 to 39.

Messenger RNA is the technology utilized by both the Pfizer and Moderna COVID-19 vaccines, the most administered vaccines in the United States and a number of other countries.

The new guidance came after the Florida Department of Health carried out an analysis to evaluate vaccine safety, the department said in a bulletin on Friday.

The statewide analysis of vaccinated Florida residents aged 18 years or older (pdf) found an 84 percent increase in the relative incidence of cardiac-related deaths among males aged 18–39, within 28 days of mRNA vaccination.

“Non-mRNA vaccines were not found to have these increased risks,” the Florida Department of Health noted.

Given the high level of global immunity to COVID-19, the benefit of vaccination with mRNA vaccines “is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group,” the department said.

“As such, the State Surgeon General recommends against males aged 18 to 39 from receiving mRNA COVID-19 vaccines,” it said. “Those with preexisting cardiac conditions, such as myocarditis and pericarditis, should take particular caution when making this decision.”

“Far less attention has been paid to safety and the concerns of many individuals have been dismissed—these are important findings that should be communicated to Floridians,” Ladapo said in a statement, referring to the analysis.

In the new guidance (pdf), Florida’s health department said it also “continues to stand by” its guidance for pediatric COVID-19 vaccines it issued in March. That guidance (pdf) recommends against COVID-19 vaccination for healthy children and adolescents aged 5–17. It now also recommends against COVID-19 vaccination among infants and children under five years old.

Statewide Analysis

The analysis from the Florida Health Department that informed Ladapo’s latest recommendation had sought to “evaluate the risks of all-cause and cardiac-related mortality following COVID-19 vaccination.”

Residents in Florida aged 18 years or older who died within 25 weeks of having received a COVID-19 vaccine, since the start of the vaccination roll-out in the state—Dec. 15, 2020—were included. The study end date was June 1, 2022.

People were excluded from the study if they had a documented COVID-19 infection, had a COVID-19 associated death, had received a COVID-19 vaccine booster, or had received their last COVID-19 vaccine after Dec. 8 2021. The last criterion was put in place to make sure that each person was followed up after 25 weeks.

The study found that COVID-19 vaccination “was not associated with an elevated risk for all-cause mortality,” but “was associated with a modestly increased risk for cardiac-related mortality 28 days following vaccination.”

“Results from the stratified analysis for cardiac-related death following vaccination suggests mRNA vaccination may be driving the increased risk in males, especially among males aged 18–39,” according to the analysis.

It also noted that the risk for both all-cause and cardiac-related deaths was “substantially higher 28 days following COVID-19 infection.”

As such, the study concluded that people should weigh the risk associated with mRNA vaccination with the risk associated with COVID-19 infection.

The analysis was a self-controlled case series (SCCS), which is a study design originally developed to evaluate vaccine safety, the department stated. The SCCS method uses individuals as their own control, such that comparisons are made within individuals.

The U.S. Food and Drug Administration’s authorization of the Pfizer-BioNTech and Moderna COVID-19 vaccines for emergency use in 2020 marked the first time it did so for vaccines that use mRNA technology.

According to the FDA, the mRNA vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the distinctive spike protein of the virus. When a person receives the vaccine, their body produces copies of the spike protein which “does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response” against the virus, according to the agency.

The mRNA-based COVID-19 vaccines from Pfizer-BioNTech and from Moderna have both been linked with heart inflammation, including myocarditis and pericarditis, data from around the world have suggested. Younger populations, especially young men, have been observed to experience these conditions at much higher than expected rates, data from the Centers for Disease Control and Prevention (CDC) previously suggested. A small number of deaths from heart inflammation after COVID-19 vaccine have also been reported.

The primary regimens of the vaccines, which are two doses administrated several weeks apart, were insufficient to protect against infection and showed waning efficacy in protecting against hospitalization amid newly-emerging variants. This prompted the governments of many countries to recommend boosters and subsequent boosters throughout the COVID-19 pa

High cholesterol, overweight and reduced physical stamina are long COVID sequelae in young adults

Authors: University of Zurich Summary: 6, 2022:Science Daily

As the Covid-19 pandemic evolves, the issue of post-infection consequences is growing in significance. Does Long Covid impact previously healthy young adults? Although this group is of great societal importance, representing the next generation and the backbone of the workforce, the intermediate-term and long-term effects of SARS-CoV-2 infections have scarcely been researched in this population. Available original research tends to focus on sufferers who were hospitalized, the elderly or those with multiple morbidities, or restricts evaluations to a single organ system.

Long Covid implications in young Swiss military personnel

A new study, funded by the Swiss Armed Forces, and conducted under the leadership of Patricia Schlagenhauf, Professor at the Epidemiology, Biostatistics and Prevention Institute of the University of Zurich (UZH), has now evaluated possible Long Covid implications in young Swiss military personnel. The study, published in the journal Lancet Infectious Diseases, was done between May and November 2021 with 29 female and 464 male participants with a median age of 21. 177 participants had confirmed Covid-19 more than 180 days prior to the testing day, and the control group was made up of 251 SARS-CoV-2 serologically negative individuals. Unlike other studies the novel test battery also evaluated cardiovascular, pulmonary, neurological, ophthalmological, male fertility, psychological and general systems.

Despite overall recovery also sequelae after recent infections remain

The findings show that young, previously healthy, non-hospitalized individuals largely recover from mild infection and that the impact of the SARS-CoV-2 virus on several systems of the body is less than that seen in older, multi-morbid or hospitalized patients. However, the study also provided evidence that recent infections — even mild ones — can lead to symptoms such as fatigue, reduced sense of smell and psychological problems for up to 180 days, as well as having a short-term negative impact on male fertility. For non-recent infections — more than 180 days back — these effects were no longer significant.

Specific constellation carries risk of developing metabolic disorders

For those with non-recent infections, however, the study — which had a long follow-up — provided evidence of a potentially risky constellation: “Increased BMI, high cholesterol and lower physical stamina is suggestive of a higher risk of developing metabolic disorders and possible cardiovascular complications,” says principal investigator Patricia Schlagenhauf. “These results have societal and public-health effects and can be used to guide strategies for broad interdisciplinary evaluation of Covid-19 sequelae, their management, curative treatments, and provision of support in young adult populations.”

Significant landmark study points the way

The study, conducted in collaboration with clinics at the University Hospital Zurich and Spiez Laboratory, is novel in that it quantitatively evaluated multi-organ function using a sensitive, minimally invasive test battery in a homogenous group of people several months after a Covid-19 infection. A valuable facet of the study was the control group, serologically confirmed to have had no SARS-CoV-2 exposure. “This combination of a unique test battery, a homogenous cohort and a control group make this a very powerful, landmark study in the evidence base on Long Covid in young adults,” says Schlagenhauf.

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Story Source:

Materials provided by University of ZurichNote: Content may be edited for style and length.


Journal Reference:

  1. Jeremy Werner Deuel, Elisa Lauria, Thibault Lovey, Sandrine Zweifel, Mara Isabella Meier, Roland Züst, Nejla Gültekin, Andreas Stettbacher, Patricia Schlagenhauf. Persistence, prevalence, and polymorphism of sequelae after COVID-19 in unvaccinated, young adults of the Swiss Armed Forces: a longitudinal, cohort study (LoCoMo)The Lancet Infectious Diseases, 2022; DOI: 10.1016/S1473-3099(22)00449-2

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.

Download Complete Study Publication

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.

UK Govt Denies ‘Safe Use’ Recommendation for Pfizer Vaccine In Pregnant Women, Says Those Breastfeeding Should NOT Be Vaccinated.

FURTHER STUDIES ARE BEING CONDUCTED TO ASCERTAIN MORE DETAILS ABOUT THE IMPACT OF THE VACCINES.

Authors:  NATALIE WINTERS AUGUST 30, 2022 The National Pulse

The British government has recommended against pregnant and breastfeeding women receiving the Pfizer COVID-19 vaccine, admitting that “sufficient reassurance of safe use of the vaccine” for the demographic “cannot be provided at the present time.”

The findings were revealed in a comprehensive report from the country’s Department of Health and Social Care, “Summary of the Public Assessment Report for COVID-19 Vaccine Pfizer/BioNTech,” last updated on August 16th. The report was published through the government’s Medicines & Healthcare products Regulatory Agency.

The report’s “Toxicity Conclusions” section outlines why the department recommends against pregnant and breastfeeding women receiving the vaccine, noting:

“In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: however, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated.

“The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need. In principle, a decision on Licensing a vaccine could be taken in these circumstances without data from reproductive toxicity studies animals, but there are studies ongoing and these will be provided when available,” continued the report.

The admission follows controversy over several Western governments’ hasty approvals and, in some cases, mandates of COVID-19 vaccines.

In the U.S., following a massive lobbying campaign by pharmaceutical giants including Pfizer, many jobs, businesses, and schools required COVID-19 vaccination for entry. As a result, companies including Pfizer have enjoyed record-breaking profits throughout the COVID-19 pandemic.

The British government’s report also follows U.S. health agencies such as the Food and Drug Administration (FDA) appearing to slow roll the release of data relevant to the efficacy and long-term health implications of the COVID-19 vaccine.

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.

The CDC Is Breaking Trust in Childhood Vaccination

With its unscientific push to vaccinate all infants and toddlers against COVID, the agency will harm vaccine uptake for more significant diseases

Authors: LESLIE BIENEN, TRACY BETH HØEG JULY 05, 2022 Tablet

On June 18, the U.S. Centers for Disease Control and Prevention (CDC) officially recommended Pfizer and Moderna COVID-19 vaccines for all children between the ages of 6 months and 5 years. While the Food and Drug Administration (FDA) is the agency responsible for authorizing emergency use of vaccines, it’s the CDC that crafts subsequent messaging, makes specific recommendations, and prioritizes who can, should, or should not get vaccinated. In her briefing, CDC Director Rochelle Walensky strongly urged all parents of the nearly 20 million American children in this age group to vaccinate them as soon as possible.

For some parents, Walensky’s briefing came as a huge relief. But if polling from May is anything to go by, a larger number of parents likely greeted the recommendation with skepticism. Even before the underwhelming trial results came out, only 18% of surveyed parents reported that they planned to vaccinate their babies and toddlers. Nationally, uptake in minors between the ages of 5 and 11 as of June 22, 2022, was 29% receiving two doses, and 36% receiving one, but vaccine requirements for sports, camps, and other activities likely drove an unknown percentage of vaccination in this age group.

There remains, moreover, no solid consensus among physicians about the importance of vaccinating healthy children against COVID-19. A survey from December 2021 indicates that as many as 30%-40% may not be recommending COVID vaccination for children ages 5 to 17, to say nothing of infants. A recent editorial in The Lancet expressed uncertainty about whether the benefits of vaccinating healthy 5- to 11-year-olds outweigh the risks, especially in those with a history of infection.

The gap between the CDC’s enthusiasm for vaccinating all children against COVID and that of parents and health care providers is unlikely to be bridged by approval under Emergency Use Authorization. Approval for the COVID vaccines in infants and toddlers is based on two trials that used changes in antibody levels as an estimate of efficacy, but did not assess protection from severe disease, hospitalization, or multisystem inflammatory syndrome in children (MIS-C), important outcomes that parents worry about. In a Food and Drug Administration (FDA) meeting on June 28, Pfizer Vice President for Viral Vaccines Kena Swanson even acknowledged that “there is no established correlate” between antibody levels and protection from disease.

In the Pfizer trial, the confidence interval—which shows the possible range of protection level—was alarmingly wide, with the lower bound suggesting the possibility of a 380% increase in the chance of infection after the third dose. Additionally, neither trial met the 50% efficacy requirement established by the FDA for approval of adult COVID vaccines. Peter Marks, the FDA’s top vaccine official, told Congress in May that the efficacy requirement would be lowered for the pediatric vaccine simply because vaccine efficacy against the omicron variant was lower in general.

With rates of severe disease now much lower in children than at the start of the pandemic—due to higher levels of natural immunity and lower rates of severe disease caused by omicron—trials would have needed to enroll hundreds of thousands of children, if not over a million, in order to detect a significant impact of the pediatric vaccine against severe disease. Vaccine companies could have conducted such time-consuming and costly trials, especially if there had been interest in international collaboration. But there was no economic incentive to do so, and every economic incentive not to: Speed, not providing meaningful information to parents and physicians about safety and efficacy, was the priority of U.S. regulatory agencies.

Because Pfizer and Moderna were permitted to seek approval for pediatric COVID vaccines under the emergency use pathway, Moderna only enrolled 6,300 total children in trials (4,700 in the vaccine group and 1,600 in the placebo group), and Pfizer only enrolled 4,526 total (2,750 in the vaccine group and 1,776 in the placebo), with two-thirds dropping out before the third dose. The trials, in other words, enrolled only a fraction of the number of participants that would have been required to determine efficacy against end points like severe disease, hospitalization, and rare adverse events such as myocarditis, which has been linked to COVID vaccination in males in the 12- to 17-year-old age group at a rate of up to 1 in 2,700.

Furthermore, the follow-up time after the second dose of Moderna and the third dose of Pfizer was only 1-3 months. Data from adults show protection against infection is transient, though protection against severe disease so far seems longer lasting. For the Moderna vaccine, efficacy against infection was not statistically significant for children between 6 months and 2 years, according to one of the company’s two analyses. In the Pfizer trial, there was no evidence of efficacy for the first two doses against omicron for this age group; the “effect” seen after the third dose was so uncertain that it is impossible to draw firm conclusions about how well the vaccine worked to prevent cases.

Still more puzzling is the fact that neither Pfizer nor Moderna—despite continued assurances that mRNA vaccines are uniquely flexible, allowing manufacturers to quickly tweak vaccines to match new variants—has released an updated version of their product: The pediatric vaccines now being administered target an outdated variant. In addition, the infant and toddler trials were mostly limited to children who had not been previously infected with COVID (estimates based on blood work showed less than 15% of children enrolled had previously been infected). With 75% of children nationally having already been infected by February 2022, the immune-naïve children enrolled in the trial were not representative of their age group at large.

Even in the already troubled context of the last two years, the CDC’s unqualified recommendation to vaccinate every young child against COVID may further contribute to the profound chasm of trust between U.S. citizens and their public health agencies. In January, a Hart poll found that only 44% of respondents said they believe what the CDC says; a March Gallup poll put it at 32%. Evidence of trust slippage can be seen even in highly vaccinated places like Portland, Oregon, where CDC recommendations were for the most part embraced unquestioningly during the pandemic. Despite the CDC’s recommendation that all children 5 and up should receive a booster, as of June 26 only 8.7% of children ages 5-11 in the Portland area are boosted, compared to 3.9% in the entire state of Oregon. (The CDC and American Academy of Pediatrics have not made nationwide data available.)

The general trust deficit is more troubling than skepticism toward this particular vaccine, because it could conceivably drive down uptake of other childhood vaccines that we know are more important to children’s health, such as those against measles, mumps, rubella, diphtheria, polio, and Haemophilus influenza type b (Hib). This is not an alarmist or trivial concern, as vaccinations are one of the most lifesaving medical interventions in human history, rivaled perhaps only by antibiotics. In 1800, 46% of American children did not make it to age 5, and the majority died from what are now vaccine-preventable diseases. The smallpox vaccine alone is estimated to have saved 150 million to 200 million lives. Rates of diseases such as tetanus, rubella, polio, Haemophilus influenza type b (Hib) have declined by 99% since widespread childhood vaccination became commonplace in the 20th century.

It is therefore worth our attention when, for example, a recent letter in the New England Journal of Medicine noted that flu shot uptake has decreased over the pandemic, which the authors suspect may be due to growing vaccine hesitancy in general. The CDC published a study in April showing that childhood vaccination rates fell by only 1% in 2021, a small proportion of the total when spread over 70 million children. But given that many of these vaccines require two or three doses for full coverage, this still translates to several million missing doses, and could threaten herd immunity for diseases such as measles, which require very high percentages of the population to be vaccinated. It is also difficult to separate out the factors behind this drop in coverage, because schools and local clinics—where many low-income children receive vaccines—were closed for much of the last two years. But it is reasonable to at least assume that low trust in the CDC, the agency responsible for making evidence-based recommendations about vaccines, is not helping.

Compare the CDC’s response to vaccine hesitancy during COVID to a similar challenge in the late 1990s and early 2000s: rotavirus. Only a year after Andrew Wakefield’s false claims in 1998 that the MMR vaccines caused autism—leading to one of the most disastrous setbacks for vaccination uptake in history—Wyeth’s RotaShield vaccine was pulled off the market due to evidence it caused a rare and serious intestinal malfunction (intussusception) in babies. The effect of the RotaShield withdrawal so hard on the heels of the Wakefield disaster is hard to isolate, but CDC officials acknowledged that the combined events led to “a particularly turbulent period” for U.S. vaccine programs. Referring to vaccine hesitancy that might result from the RotaShield adverse events, the CDC’s Dr. John Livengood remarked at the time that the CDC “shouldn’t be seen as withholding information right now.”

The original trial for RotaShield had enrolled 10,054 vaccine recipients and 4,633 placebo recipients. During a February 1998 meeting of the CDC’s Advisory Committee on Immunization Practices (the same body that recently met to discuss the pediatric COVID vaccines), an FDA panel member, Dr. Margaret Rennels, noted that more babies in the vaccine group experienced intestinal intussusception than in the placebo group by about 2.5-fold, with a rate of 1/2011 (0.05%) in the vaccine group compared with 1/4633 (0.02%) in the placebo. But because the absolute numbers were small, and the trial was also relatively small, intestinal intussusception did not achieve statistical significance. RotaShield was licensed by the FDA in 1998, widely rolled out, and championed by the CDC in the spring of 1999. Intussusception was not mentioned further, and the issue was buried in a 19-page document where it was listed as a side effect that did not occur significantly more often in vaccinated babies than in the control group.

By summer, however, officials at the CDC grew concerned about a growing number of intussusception reports from the Vaccine Adverse Event Reporting System (VAERS), and were anxious not to lose gains made during the Carter and Clinton administrations in raising general childhood vaccination rates. By the end of President Clinton’s first term, toddler immunization rates had achieved what was then an all-time high, thanks to Vaccines for Children, a program that expanded access to free and low-cost vaccination.

The CDC was also cognizant that Wakefield’s false claims were continuing to spur a growing movement of vaccine hesitancy. As a result, the CDC—then under the direction of Dr. Jeffrey Koplan—immediately launched a large-scale investigation into the RotaShield VAERS reports. The investigation concluded that one additional case of intussusception was attributable to the vaccine for every 5,000-10,000 infants vaccinated—lower than rates of myocarditis due to vaccine injury in COVID-vaccinated adolescent males age 12-17.

RotaShield was pulled off the market that October. To justify the decision to pull a vaccine that was 85% effective at preventing hospitalization from a viral infection that had killed hundreds of thousands of infants worldwide, CDC personnel wrote the following:

At a time when many parents express concerns about the safety of vaccines and vaccine adverse events are the focus of increasing attention by the public, media, and U.S. Congress, the wisdom of recommending a vaccine that causes a severe adverse reaction in an estimated 1 in 10,000 infants must be considered.

The next vaccine against rotavirus—RotaTeq, made by Merck and released in 2004—was only released after the Rotavirus Efficacy and Safety Trial (REST) trial, which was notable for its “[randomized] design, large sample size, detailed execution, continuous safety monitoring, and lengthy duration,” and was undertaken in direct response to the perceived failures of the RotaShield trial. The authors of a paper describing its execution wrote, “The design and conduct of this study may serve as a useful tool for planning other future clinical trials, especially those evaluating uncommon adverse events.” The REST trial was conducted in 11 countries at more than 500 study sites and enrolled 70,000 subjects (including over 35,000 infants from the United States), making it one of the largest vaccine clinical trials ever conducted pre-approval. Post-approval, Merck conducted an additional study enrolling more than 85,000 infants.

The obvious drawback of a trial like REST is that it took four years to complete (though today it could almost certainly be completed faster due to advances in recruitment methods). A multiyear trial was simply not an option during COVID, which is why the notably small and short COVID vaccine trials were allowed to serve as the basis for approval under the emergency use provision. But because COVID so rarely causes severe disease in children, and current COVID vaccines do not reliably prevent transmission, especially after a few months, it is difficult to understand how such small trials could be justified without meaningful endpoints for this age group.

Consider the case of rotavirus again. Prior to vaccination, rotavirus was a significant cause of morbidity and mortality in infants in the United States (and still is globally). Until 15 years ago, it was the leading cause of gastrointestinal hospitalization in babies in the United States and, prior to rotavirus vaccines, caused an estimated 50,000-70,000 hospitalizations per year in infants. Compare this figure with the number of children age 0-4 hospitalized with COVID: The CDC places the cumulative total during the entire pandemic at approximately 130 in 100,000, or about 26,000 children. The CDC estimates that during omicron, at least 14% of COVID hospitalizations for children ages 6 months to 4 years were incidental (meaning the need for hospitalization was due to something other than COVID itself), though this is likely an underestimate, as 63% of current COVID hospitalizations in the U.K. for all ages are “incidental.” Thus, at the time rotavirus vaccines were being trialed, there were 2-4 times more hospitalizations for rotavirus in this age group than there have been for COVID since the pandemic began. (The CDC estimates the death rate from COVID in 6-month- to 4-year-olds to be 86 per year, compared with 20-60 per year from rotavirus, but the COVID estimate does not separate out deaths primarily due to another cause, nor does it adjust for the reduction in severity associated with omicron for children in this age group.)

The rotavirus experience taught the CDC a hard-earned lesson: Speaking in absolutes about vaccine safety and efficacy regardless of trial standards can backfire. In nearly every dimension by which trial data are measured—proper endpoints, size, rigorous randomization, and other factors—the RotaShield trial was far more robust than the Pfizer and Moderna infant and toddler COVID vaccine trials. Furthermore, if the identification of safety signals is not quickly acknowledged, it becomes even harder to recover trust. More and more Americans are wondering, for example, why Canada and several European countries have advised against the Moderna vaccine for people under 30 due to myocarditis risks, while the U.S. government still won’t even acknowledge the higher risk of myocarditis.

Clinical trial data expert and Tablet contributor Dr. Vinay Prasad has pointed out many times that “expedited pathways do not always benefit people, but they always benefit companies.” This might help explain why no other country in the world has started vaccinating infants against COVID, and only a handful have vaccinated toddlers. (In addition to the United States, the only countries vaccinating 2- to 3-year-olds against COVID right now are Cuba, China, Argentina, Bahrain, Venezuela, Colombia, Hong Kong, and Chile, none of which are using mRNA vaccines.) It is perhaps especially damning that no other country collaborated with the United States on the mRNA COVID-19 vaccine trials for infants and toddlers, which could have quickly enabled enough trial participation to study effects of the vaccines against severe disease, as was done in the RotaTeq trial. Tellingly, the Danish minister of health recently claimed that it was a “mistake” to vaccinate children under 16 against COVID at all, saying, “we’ve gotten smarter and would not recommend the same today.”

In June, the CDC had the chance to help rebuild public trust: In the absence of trials and data that would have met the gold standard for scientific rigor, the CDC could have made a softer recommendation based on the data it does have. It could have been honest about the trials’ shortcomings and what these data do and do not show. It could have told the public that the data are preliminary, do not establish efficacy against severe disease or long COVID, and do not rule out the possibility of a rare adverse event. Perhaps it could have recommended COVID vaccines for high-risk children, and remained cautious about the benefits for healthy children who have already had COVID infections. The CDC and FDA together could have insisted that blanket approval and recommendations would only come after a properly conducted vaccination trial—one that would give pediatricians and public health officials the confidence to make the evidence-based recommendations parents are seeking.

In 1999, the CDC, working closely with the FDA, took such steps to shore up parents’ confidence in their recommendations. After the RotaShield withdrawal, the FDA requested that future trials of any rotavirus vaccine enroll at least 60,000 children. This level of accountability and collaboration between the two agencies responsible for vaccines in the United States resulted in the delivery of a widely trusted vaccine against a virus that posed a similar or greater danger to young children than COVID-19. This level of accountability was what the American public reasonably expected of its public health agencies two decades ago. It’s not too much to expect today.

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.”