The regulatory agency expanded clearance of a third Pfizer shot to children aged 5 to 11 at least five months after their second dose.
The extra shot is needed because of waning protection from the primary series, which is two doses, Dr. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The decision drew some criticism.
“There is no evidence that children 5-11 years old need a booster shot of the vaccine, nor of demonstrated benefit,” Dr. Monica Gandhi, an infectious disease expert at the University of California, San Francisco, told The Epoch Times via email.
The data underpinning the move comes from just 67 children, who are part of Pfizer’s ongoing trial evaluating the vaccine it made with Germany’s BioNTech.
Antibody responses were evaluated in the kids, all of whom received a third dose seven to nine months after getting a second dose.
The level of antibodies against the virus that causes COVID-19 “was increased” compared to before getting the booster dose, according to the FDA. All of the kids received a third dose seven to nine months after getting a second dose.
Safety data from a group of about 400 children between the ages of 5 to 11 who received a booster also supported the authorization.
The data has not been peer-reviewed or otherwise published in full since being outlined in a press release from Pfizer and BioNTech in April.
The data did not include an evaluation of whether a booster shot helped against symptomatic COVID-19 or severe disease.
“Antibodies are expected to increase after a booster dose but that does not necessarily translate to clinical benefit,” Gandhi said. “Given that young males are more at risk of a rare adverse effect called myocarditis (inflammation of the heart) with mRNA vaccination, the risk versus benefits of giving a 3rd shot to 5- to 11-year-olds is not clear from the data.”
Pfizer’s vaccine is built on messenger RNA (mRNA) technology.
The vaccine for all age groups has proven less effective against Omicron, the strain of the CCP (Chinese Communist Party) virus that became dominant in the United States in late 2021. The CCP virus, also known as SARS-CoV-2, causes COVID-19.
The emergency authorization for Pfizer’s shot is for the prevention of COVID-19.
Regulators authorized Pfizer’s primary series for kids aged 5 to 11 in the fall of 2021. Since then, approximately 10 million have received at least one dose.
Authorities are still pushing vaccination, asserting that the protection against severe illness outweighs the vaccine’s risks, including heart inflammation.
“Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe,” Dr. Robert Califf, the FDA’s commissioner, said in a statement.
In clearing the shot for children as young as 5, the FDA continued a growing trend of not asking its panel of expert advisers whether it should grant or reject Pfizer’s request for authorization.
“Where is the transparent process the public was promised? Once again, the FDA rubber stamped without holding an Advisory Committee and an opportunity to hear discussion and rationale,” Kim Witczak, co-founder of the drug safety group Woody Matters, told The Epoch Times in an email. “Yet another decision with major safety consequences made behind closed doors. Our children are not guinea pigs.”
Multiple members of the panel previously questioned whether the vaccine from Pfizer should be given to all children.
After three studies published earlier this year showed the effectiveness of the shot was worse than originally stated, Dr. Cody Meissner, one of the members, told The Epoch Times that the benefit of the vaccine “roughly equals the risk of harm” for most kids.
The Centers for Disease Control and Prevention is convening its panel on May 19 to discuss COVID-19 vaccine booster doses.
The FDA decides whether vaccines should be authorized for certain populations. The CDC then decides whether to recommend vaccines for those groups. Both agencies typically consult their advisory committees on their actions.