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COVID-19 Resource Center

Disclosures: D’Amelio is employed by Pfizer. Gottlieb is a member of Pfizer’s board of directors.
September 15, 2021
2 min read
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Pfizer vaccine could be authorized for younger children sooner than expected

Disclosures: D’Amelio is employed by Pfizer. Gottlieb is a member of Pfizer’s board of directors.
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The Pfizer-BioNTech COVID-19 vaccine could be authorized for emergency use in children aged 5 to 11 years by the end of October, representatives from the company said, moving up the timeline by at least a month.

A Pfizer executive indicated that a decision on authorizing the vaccine in even younger children — those aged between 6 months and 5 years — also could come sooner than expected.

Pfizer vaccine
Younger children may have access to a COID-19 vaccine by Halloween. Source: Adobe Stock

Former FDA commissioner Scott Gottlieb, MD, now a member of the Pfizer board of directors, said last month that he expected the company to have data on children aged 5 to 11 years by the end of September and that FDA emergency authorization would likely come in “early winter.”

In an interview on ABC’s Face the Nation this past Sunday, Gottlieb changed that timeline, saying that children in this age group could potentially have access to the vaccine by the end of next month “if everything goes well.”

Scott Gottlieb

“The FDA has said it's going to be a matter of weeks, not months, in terms of their evaluation of that clinical data, to make the determination whether they're going to authorize vaccines for kids aged 5 to 11,” Gottlieb said. “I interpret that to mean perhaps 4 weeks, maybe 6 weeks, but I think in a best-case scenario, given that timeline I've just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween.”

Gottlieb’s statements were backed up on Tuesday by Pfizer CFO and executive vice president of global supply Frank D’Amelio, who spoke about the vaccine during a Morgan Stanley health care conference.

“We're conducting phase 3 studies for children between the ages of 6 months and 11 years old,” D’Amelio said. “And we expect to have safety and immunogenicity data for children between the ages of 5 and 11 ... by the end of September, and we would expect to follow that with the FDA in early October.”

D’Amelio also said that he expects the company to file data for children between the ages of 6 months and 5 years “in the weeks shortly after” submitting data for the older group.

Gottlieb said that once the vaccine is authorized — assuming a positive FDA decision — parents should consult their child’s pediatrician about how to proceed.

“Pediatricians are very good at counseling through these decisions, and I think that they can provide good, objective advice to parents,” he said.

According to the AAP, after declining in early summer, cases of COVID-19 have increased exponentially among children, who now comprise almost 30% of all new cases in the United States.

The AAP has recently ramped up efforts to convince parents to vaccinate eligible children, including through a CDC-backed advertising campaign. It also has discouraged providers from administering the Pfizer-BioNTech vaccine off-label to children aged younger than 12 years since it won full approval last month for people aged 16 years or older.

References:

D’Amelio, F. Morgan Stanley webcast. September 14, 2021.

Gottlieb, S. Face the Nation. September 12, 2021.