It’s still not time for the younger children to get themselves vaccinated. A request was filed with the US Food and Drug Administration in the first week of February by Pfizer and BioNTech. They sought an emergency use authorization of their vaccine in children 6 months to 5 years old. The FDA’s Vaccines and Related Biological Products Advisory Committee was scheduled to meet on February 15 to go over data from vaccine trials and suggest whether a two-dose vaccine regimen should be authorized. However, FDA postponed the meeting because “new data have recently emerged.”
According to the Washington Post, although the data supported the safety of the vaccines, it also showed disappointing effectiveness. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, during a news briefing, stated that the agency needs to see data from an ongoing trial of a third vaccine dose in these younger children in order to move forward with emergency use authorization.
On Friday, Pfizer and BioNTech said that they expect to have data on three doses available in early April. The information came in “so rapidly” during the Omicron wave “that at this time, it makes sense for us to wait until we have the data from the evaluation of a third dose before taking action,” Marks said. Children have a lower risk of serious outcomes from a Covid-19 infection compared with elderly or immunocompromised adults. As a result, FDA says it will move as fast as it can.