The wait for a COVID-19 vaccine may soon (finally, actually, after many delays) be over for parents of young children. The Food and Drug Administration (FDA) just accepted Pfizer’s application for authorization of their COVID-19 vaccine for the under 5 crowd. Children under age 5 are the only remaining segment of the U.S. population without an approved COVID vaccine, and the potential approval comes after months and months of delays.
Pfizer originally had pulled its initial application back in February. The data accompanying the original application left some doubts about the effectiveness of the two-dose vaccine for children aged 2 to 5 years, though children under 2 responded well and developed the anticipated immunity. The company opted to pull that application and wait for more data on the potential efficacy of a third dose of the vaccine before resubmitting the application to the FDA for approval.
The three-dose vaccine seems to have done the trick. Data released by Pfizer shows that three doses is 80% effective at preventing symptomatic COVID-19 in young children, though that figure is based on only 10 cases of COVID-19. The biotech company will perform a more thorough analysis once 21 cases have been diagnosed within the study group.
The two-dose Moderna vaccine is said to be 51% effective in children six months to 2 years and 37% effective in children aged 2 to 6.
Both companies expect deep scrutiny of side effects, which they both list as “tolerable,” though there is evidence that the vaccines can cause high fevers in children.
Although Pfizer’s application has been submitted, there’s still no timetable of when or if it will actually be approved and become available to the public. "We recognize parents are anxious to have their young children vaccinated against COVID-19, and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach," said an FDA spokesperson.
The FDA’s independent advisory panel, the Vaccines and Related Biological Products Advisory Committee, will hold hearings later this month for both the three-dose Pfizer vaccine and the two-dose Moderna vaccine, which was submitted for approval on April 28. If approved, the applications will be reviewed by the Centers for Disease Control and Prevention and could be available to consumers as early as late June.