COVID-19 vaccines could be available for children as young as 6 months old within weeks — far sooner than previously expected in what experts say would be a major step toward slowing the spread of the virus and mitigating the disruption caused by the pandemic, assuming parents can be convinced the shots are safe and necessary.
Pfizer and BioNTech applied for emergency use authorization from the Food and Drug Administration for a two-dose regimen of their vaccine for children 6 months to 4 years old Tuesday, with a decision potentially coming before the end of the month. The FDA reportedly urged the companies to submit their data even though trials on a third dose are still in progress.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus…,” Albert Bourla, Pfizer chairman and CEO said in a statement. “If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”
In December, Pfizer reported initial trial results on the two-dose version of the vaccine produced an insufficient immune response in children ages 2 to 4, although the response in children under 2 was strong. Executives were confident a third dose would provide a more reliable response, but data would not be available until late March.
According to former FDA Commissioner Dr. Scott Gottlieb, a member of Pfizer’s board, federal health officials shifted their thinking on the child vaccine in recent weeks. The two-dose regimen was less effective at preventing infection in young children than adults, but it still prevented serious symptoms.
“If the goal of the vaccine is to get baseline immunity in the kids to prevent really bad outcomes, and you’re really not using the vaccine as a tool to prevent infection in the first place, two doses could do that,” Gottlieb said on CBS’ “Face the Nation” Sunday.
Sources said officials recognize two doses will not be enough, but seeking authorization now could allow children to get their initial shots sooner and be ready for a third dose when it is approved. The data they have collected does not indicate any safety concerns, and even with reduced effectiveness, they believe the two-dose vaccine could prevent a significant number of infections.