Pfizer Applies to FDA for Emergency Use Approval of Vaccine in Kids Ages 5-11

Yesterday, Pfizer BioNTech applied for approval from the US Food and Drug Administration for emergency use authorization for their Covid-19 vaccine for children ages 5 to 11. If authorized it would be the first vaccine for younger children. The vaccine is currently approved for people ages 16 and older and has an emergency use authorization for people 12 to 15. Last month Pfizer released data from a phase 2/3 trial that showed it’s Covid-19 vaccine was safe and generated a ‘robust’ antibody response to kids age 5 to 11. The trial included over 2,200 participants and used a two-dose regimen of the vaccine given 21 days apart.

In the trial, participant’s immune responses were measured by looking at antibody levels in their blood and comparing them to levels of a control group of 16 to 25 year old’s who were given a two-dose regimen with 30-micrograms.  Pfizer said the levels compared well with older people who received the larger dose, demonstrating a ‘strong immune response in this cohort of children one month after the second dose.’ Pfizer began submitting data on the vaccine for younger children to the FDA late last month but hadn’t formally requested authorization until now. The FDA has scheduled a meeting to discuss the vaccine in children ages 5 to 11 on October 26th.