In mid-June, a Food and Drug Administration committee will meet to review data on COVID-19 vaccines for children aged six months to five years. announced on Monday† If everything goes as expected, it can sign the photos for that age group within days of that meeting.
The announcement came just after Pfizer/BioNTech said in a Monday morning press release that three doses of their COVID-19 vaccine elicited a strong immune response in children between six months and five years old. They plan to file the data with the Food and Drug Administration this week.
A preliminary analysis of data from the clinical trial involving 1,678 children also showed that the injections were approximately 80 percent effective in preventing symptomatic COVID-19 infections, but that was based on only a small number of cases, according to the press release.
The injections for this age group are one-tenth the dose of the Pfizer/BioNTech adult vaccines. The companies had originally tested two shots of that lower-strength vaccine in children in this age group, but the data has been released on the end 2021 showed that two shots did not elicit a strong immune response in that group. The companies then added a third chance to their trial. The FDA originally said it would review the vaccine for children under five before full data was available, but ran that back early February — a setback for parents eager to vaccinate their young children.
moderna asked the FDA to approve its vaccine for children aged six months to six years in March. It uses one-fourth the dosage as the adults’ injections, and the company said two injections were enough for an immune response similar to that seen in adults. The FDA will review Moderna’s data, along with Pfizer/BioNTech data, at its June meeting.
It is a long wait for parents of children in that age group, who will be the last to qualify for the life-saving shots. The wait was made even more terrifying by the ommicron variant-driven spikes in COVID-19 cases in the United States, causing record numbers of children under five in hospital.
“We know parents would like us to determine if these vaccines are safe and effective,” says the FDA tweeted monday† “We are working as quickly as possible to carefully review all data.”
SOURCE – www.theverge.com