Pfizer, BioNTech asks FDA to allow COVID-19 vaccine for kids under 5 years of age
Categories: Covid 19
Pfizer on Wednesday asked the US to authorize extra-low doses of its COVID-19 vaccine for children under 5, potentially opening the way for the very youngest Americans to start receiving shots as early as March. In an extraordinary move, the Food and Drug Administration had urged Pfizer and its partner BioNTech to apply earlier than the companies had planned. "I would say the parents in my office are desperate" to get their youngest kids vaccinated, said Dr Dyan Hes, who runs a paediatrics practice in New York City where vaccination rates are high. For many, "that's the first thing they ask when they walk through the door: When do you think the shot is going to come out?" "If the FDA agrees, Pfizer shots containing one-tenth of the dose given to adults could be dispensed to children as young as 6 months." Pfizer said Wednesday it had started submitting its data to the FDA and expects to complete the process in a few days. An open question is how many shots those youngsters will need. Two of the extra-low doses turned out to be strong enough for babies but not for preschoolers in early testing. Pfizer is testing three shots, and the final data is expected in late March.That means the FDA may consider whether to authorize two shots for now, with potentially a third shot being cleared later if the study supports it.