A Meals and Drug Administration committee will meet in mid-June to evaluate knowledge on COVID-19 vaccines for kids six months by way of 5 years previous, the company introduced Monday. If all goes as anticipated, it may log out on the pictures for that age group inside days of that assembly.
The announcement got here simply after Pfizer / BioNTech stated in a Monday morning press launch that three doses of their COVID-19 vaccine produced a robust immune response in youngsters between six months and 5 years previous. They plan to submit the information to the Meals and Drug Administration this week.
A preliminary evaluation of knowledge from the scientific trial of 1,678 youngsters additionally confirmed that the pictures have been round 80 p.c efficient at stopping symptomatic COVID-19 infections, in response to the press launch, however that was based mostly on solely a small variety of instances.
The pictures for this age group are at one-tenth the dose of the Pfizer / BioNTech grownup vaccines. The businesses had initially examined two pictures of that lower-strength vaccine in youngsters on this age group, however knowledge launched on the finish of 2021 confirmed that two pictures didn’t generate a robust immune response in that group. The businesses then added a 3rd shot to their trial. The FDA initially indicated that it might evaluate the vaccine for teenagers beneath 5 earlier than the whole knowledge was obtainable however walked that again in early February — a setback for fogeys anxious to get their younger youngsters vaccinated.
Moderna requested the FDA to authorize its vaccine for kids aged six months to 6 years in March. It makes use of one-fourth the dosage because the grownup pictures, and the corporate stated two pictures have been sufficient for an immune response similar to the one in adults. The FDA will evaluate Moderna’s knowledge, together with Pfizer / BioNTech’s knowledge, on the June assembly.
It’s been an extended wait for fogeys of children in that age group, which is the final to turn into eligible for the lifesaving pictures. The wait was made much more anxious by the omicron variant-fueled surges in COVID-19 instances in america, which put document numbers of kids beneath 5 within the hospital.
“We all know mother and father are anxious for us to find out if these vaccines are protected & efficient,” the FDA tweeted Monday. “We’re working as rapidly as attainable to fastidiously evaluate all the information.”