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FDA Reverses Decision on COVID-19 Shots for Children Under Five Years of Age

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The Food and Drug Administration (FDA) put a halt on its speed review to allow extra COVID-19 vaccines for children under five on Feb. 11.

Pfizer and its partner, BioNTech –– the creators of one of the major COVID-19 vaccines –– were initially expected to submit a request for a potential emergency authorization of an extra low dose two-shot regimen for children six months to five years of age. This would have been the first COVID vaccine available for that age group.

The two companies have been testing a third dose after results for the two-shot regimen revealed that two doses did not provide a strong enough immune response in all age groups. The trials featured two low three-microgram doses in children below the age of five years, despite the dosage being smaller compared to that given to adults.

The immune responses of children receiving the smaller doses were expected to be similar to immune responses of adults who received larger doses. The results were in fact varied. The two-shot vaccine failed to trigger an immune response in children ages two, three and four years. However, the response in children ages six months to two years was sufficient.

Data on a third shot will not be available until early April, posing concerns to many individuals and parents amid the omicron surge. Once that information is made public, regulators are expected to authorize a third dose of the pediatric vaccine.

Kawsar Talaat, one of the principal investigators of the Pfizer pediatric trial and a physician at Johns Hopkins Bloomberg School of Public Health, remains optimistic that a third dose will receive a positive response in children under five years of age as seen in older children and adults. 

“I think that a third dose will give a nice boost, and honestly, this is really exciting — as we know from the adult data, three doses is probably better for omicron. And I think it’ll be good to have similar data for children,” Talaat said.

The FDA urged Pfizer to get approval on two extra doses of the vaccine before data on the third dose was received, but quickly reversed this course of action after a scientific review provided by Pfizer.

Dr. Peter Marks, the FDA’s vaccine chief, commented on the reversal.

“The information made us realize that we needed to see data from a third dose from the ongoing trial in order to make a determination. We take our responsibility for reviewing these vaccines very seriously because we’re parents as well,” Dr. Marks said.

“I’m feeling despair, despondent, frustrated [and] confused,” Rachel Perera, the mother of an 8-month-old from Los Angeles, said. “I feel like the goal posts have been moving.” 

Perera consulted her pediatrician, hoping that the vaccine would have been available in late 2021 but is awaiting further instruction. 

However, other individuals were skeptical in providing two extra doses before efficient data regarding the third dose before it was presented.

“I think they made the right decision to be careful and wait for the third-dose data,” Dr. Jesse Goodman, Georgetown University Professor of Medicine and former FDA vaccine chief, said.

Despite the data’s expected availability in early April, it will take the FDA and health authorities several weeks to review and reveal the information to the public.

Alexia Hawley is a City News Intern for the winter 2022 quarter. She can be reached at