Pfizer Inc. and BioNTech announced Wednesday the Biden Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for their “bivalent” mRNA COVID-19 booster shot for children aged 5-11 years without having completed clinical trials.
“As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,” said Pfizer CEO Albert Bourla. “Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.”
“In addition, we have started a clinical trial to evaluate the adapted vaccine based on the BA.4 and BA.5 subvariants in children six months through 11 years of age aiming to offer all age groups the opportunity to immunize against Omicron variants and subvariants,” Bourla added.
The FDA said in a statement justifying its authorization:
For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.
I just recommended expanding updated #COVID19 vaccines to children 5-11 years. This is a critical step in our fight against COVID-19. An updated vaccine can help bolster protection for our children this winter. Talk to your child’s healthcare provider for more information.
— Rochelle Walensky, MD, MPH (@CDCDirector) October 12, 2022
On the same day as the announcement of FDA’s EUA for the boosters for young children, first lady Jill Biden visited a Nashville, Tennessee pop-up clinic that is distributing the new mRNA shots, reported WSMV4.
“That’s our new announcement, that it was 11 and up, but now it’s 5 years old and up so come get your vaccine, your update,” Biden said at St. James Missionary Baptist Church.
“It’s so important that we keep all Americans healthy,” she added.
Meanwhile, Pfizer has teamed up with Marvel’s superhero legends the Avengers this month to promote its vaccines to children, urging them to be an “everyday hero.”
‘Everyday Heroes’? Pfizer Taps Marvel’s Avengers to Push COVID Boosters to Kidshttps://t.co/P4qFM98tzD
— Robert F. Kennedy Jr (@RobertKennedyJr) October 12, 2022
The Daily Mail reported last week the marketing effort between Pfizer and Marvel comes “amid a sluggish autumn jab rollout” of the new Omicron-specific boosters, one that has seen fewer than 1 in 20 eligible Americans receiving them.
Data from the Centers for Disease Control and Prevention (CDC) states only 7.6 million Americans have opted to get the updated booster dose as of Sept. 28.
Parents appear to be resisting having their children injected with even the primary mRNA shots.
“Less than a third of 5-to 11-year-olds have had their two primary doses and thus would qualify for the new booster,” the Associated Press’ AP News reported Wednesday.
Dr. Jason Newland, a pediatric infectious disease specialist at Washington University in St. Louis, told AP News the new mRNA booster shots are “extremely important” to keep children healthy, though most children have not become seriously ill from COVID infection.
“[T]here is no concern from the safety perspective with the bivalent vaccines, whether Moderna or Pfizer,” Newland stated, though there has been no testing.
In early September, however, one of the nation’s top vaccine experts – a member of the National Institutes of Health (NIH) working group on vaccines as well as a member of the FDA’s Vaccines and Related Biological Products Advisory Committee, advised that healthy young people not get the new COVID mRNA booster shot since “there’s not clear evidence of benefit.”
“I think that when you’re asking people to get a vaccine, I think there has to be clear evidence of benefit, and we’re not going to have clinical studies before this launches,” Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia (CHOP), told CNN in a conversation later summarized on Twitter.
Dr. Paul Offit fears CDC will recommend new Covid boosters for all when "a healthy young person is unlikely to benefit …"
After CNN pushback: "If there's not clear evidence of benefit, it's not fair to ask ppl to take a risk, no matter how small. The benefit should be clear." pic.twitter.com/cBf3RkopJj
— Scott Morefield (@SKMorefield) September 1, 2022
FDA authorized the initial Omicron-specific Pfizer booster shot despite preliminary testing having been performed only on eight mice, and no humans.
“You’d like to have at least human data, people, you know, getting this vaccine,” Offit said.
“You’re asking people to get a new product for which there’s no data,” Offit also told CNN. “Mice data are not adequate to launch 100-plus-billion-dose effort.”
As more information about the development of the mRNA shots is exposed, taking the shots has become increasingly controversial.
A top Pfizer executive admitted to a European Parliament committee Tuesday that her company did not test its COVID mRNA shot for whether it could prevent transmission of the virus before it was placed on the market and then mandated in many parts of society throughout the world.
"Get vaccinated for others" was always a lie.
The only purpose of the #COVID passport: forcing people to get vaccinated.
The world needs to know. Share this video! ⤵️ pic.twitter.com/su1WqgB4dO
— Rob Roos MEP 🇳🇱 (@Rob_Roos) October 11, 2022
“Millions of people worldwide felt forced to get vaccinated because of the myth that you ‘do it for others,’” posted European Parliament member Rob Roos. “Now, this turned out to be a cheap lie. This should be exposed.”
In new guidance at his state’s Department of Health, Florida Surgeon General Dr. Joseph Ladapo noted a study that found “an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination.”
Today, we released an analysis on COVID-19 mRNA vaccines the public needs to be aware of. This analysis showed an increased risk of cardiac-related death among men 18-39. FL will not be silent on the truth.
— Joseph A. Ladapo, MD, PhD (@FLSurgeonGen) October 7, 2022
“Individuals with preexisting cardiac conditions, such as myocarditis and pericarditis, should take particular caution when considering vaccination and discuss with their health care provider,” the guidance states.
“With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group,” the statement continues.
“The State Surgeon General now recommends against the COVID-19 mRNA vaccines for males ages 18-39 years old,” the guidance asserts.
“When it comes to COVID, public health officials have consistently downplayed and ignored natural immunity among children,” noted Liberty Counsel, which has defended the constitutional rights of religious liberty and free speech of many battling the COVID vaccine mandates.
“Yet 81 research studies confirm that natural immunity to COVID is equal or superior to any ‘vaccine immunity,’” the nonprofit law firm observed. “Research shows that there is no benefit to children receiving a COVID shot, and in fact, the shots can cause potential harm, adverse effects and death. According to Pfizer’s own study trial data, the chance of death in children from the shot is 107 times higher than death from COVID.”
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Susan Berry, PhD, is national education editor at The Star News Network. Email tips to [email protected]