On Friday, the United States Food and Drug Administration gave directions that authorize the Pfizer Inc (PFE.N) and BioNTech SE coronavirus vaccine for young children between 5 and 11. This is the first-time young children are getting the COVID-19 shot in the United States.
While the authorization has been given, the shot will not be available to the age group immediately. The U.S. Centers for Disease Control and Prevention still awaits advice on administering the shot, which will be determined from a meeting of external advisers on Tuesday.
According to Pfizer, pediatric vaccine vials will start shipping on Saturday to pharmacies, pediatricians’ offices, and other establishments where children can get the vaccine shot. The authorization comes in the wake of overwhelming voting by the panel of advisers to recommend the authorization on Tuesday. The authorization is set to make the vaccine available to 28 million American children, many of whom have returned to school for in-person learning.
With the authorization, the United States joins a few other countries, including Cuba, the United Arab Emirates and China, to clear COVID-19 vaccine administration to children in this age group and younger. According to FDA’s authorization, young children are to receive a 10-microgram dose of Pfizer’s vaccine, which is lower than the 30-micrograms dose of the original vaccine for those aged 12 and older.
The FDA panel of advisers said a lower dose could potentially reduce some of the rare side effects like myocarditis or heart inflammation, linked to Moderna (MRNA.O) and Pfizer vaccine, especially in young men. On Friday, the regulator declared that there are more benefits of the Pfizer vaccine in individuals between 5 and 11 than the risks.
The FDA has authorized a new version of the vaccine for pediatric shots that can be stored in refrigerators for up to ten weeks, thanks to the new buffer in the vaccine. About 58% of the United States’ population has been fully vaccinated, a percentage behind other countries like France and the United Kingdom. Many adults have been reluctant to get a vaccine, which may affect the turnout of children that will receive the shot.
“We are hopeful that when people see children receiving the vaccine, getting the protection they need and being able to participate in various activities without worries, more people will be encouraged to do the same,” Dr. Janet Woodcock, the acting FDA commissioner, said at a press conference. “As we continue to gain more experience with the vaccine, we hope people get safer and more comfortable with the whole process,” she added.
BioNTech and Pfizer have stated that the vaccine has a 90.7% efficiency against the coronavirus during a clinical trial of children between 5 and 11. Pfizer’s CEO Alberta Bourla said: “Parents who have been eager to protect their children have finally gotten the moment they have been waiting for.”