Pfizer and BioNTech plan on asking the U.S. Food and Drug Administration (FDA) to grant emergency use authorization for a booster for their COVID-19 vaccine for children aged 5- to 11-years-old, the companies announced on April 14.
The submission will be based on data from a Phase 2/3 clinical trial that showed a boost in antibodies from a booster dose, according to the companies.
One hundred and forty children in the trial received a booster approximately six months after the second dose. The shot comes in a two-dose primary series.
The children saw a 6-fold increase in antibodies against the Wuhan strain of SARS-CoV-2 one month after the booster, the companies said. A sub analysis of 30 participants demonstrated a 36-fold increase in neutralizing antibody titers. The trial was also said to have shown “no new safety signals.”
The data has not yet been published on a preprint server or in a journal.
“Clinical and real-world data continue to prove that a COVID-19 vaccine booster dose can keep individuals protected against severe disease,” Albert Bourla, Pfizer’s CEO, said in a statement. “We now have new, positive data in children 5 to 11 that show high immune response following a booster.”
The data is compelling the companies to ask the FDA for emergency clearance for a booster.
The FDA authorized a primary series of Pfizer’s shot for the age group in October 2021.
The FDA has said it does not comment on submissions pending before the agency but a spokeswoman told The Epoch Times last month that “our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness.”
Drug companies like Pfizer “do not apply for product distribution approvals from the FDA unless they are reasonably confident the FDA will approve,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times in an email.
The submission being made based on data from the small number of children is “a new low for scientific evidence of a vaccine’s safety and efficacy and a clear indication that the pharmaceutical industry views FDA as a rubber-stamping agency,” she added.
If authorized, few children would be eligible immediately. Just 8 million, or about 28 percent of the age group, has been fully vaccinated, according to federal data.
Many of the children who did get the two-dose primary series have not gone six months since the second dose.
On the other hand, the vaccines appear to be holding up well against severe illness.
Dr. Paul Offit, who sits on the FDA’s advisory panel, said the goal of the vaccines is to prevent severe disease.
“If Pfizer has data that shows that giving an additional dose of vaccines to the 5- to 11-year-old age group increases protection against serious disease, then let’s see it,” Offit told The Epoch Times. “Because otherwise, all they’ve shown is exactly what you expect, which is that when you give a third dose, a booster dose, that you get an increase in neutralizing antibody titers.”
The FDA, which has during the pandemic regularly bypassed the panel before making major vaccine-related decisions, should convene the committee before deciding on Pfizer’s application, Offit added.
