The authorisation of BioNTech/Pfizer’s Covid-19 jab for children under 5 years of age will be delayed after US regulators postponed a meeting of advisers to evaluate the vaccine.
The US Food and Drug Administration said on Friday it needed more time to evaluate new data supplied by Pfizer regarding its kid-sized Covid-19 jab, which is about a tenth the size of an adult dose.
The decision will delay the emergency use authorisation of a jab for children aged six months to 4 years of age for a few months, even though there are still a “staggering number” of new Covid-19 cases reported each day, the FDA said on a conference call.
The postponement of Tuesday’s meeting of external advisers follows an request by the FDA to Pfizer to accelerate its application for authorisation even though initial clinical data suggested two doses of the kid-sized jab may not be strong enough to induce protection against Covid-19.
Pfizer is currently evaluating whether a third dose of its vaccine would provide adequate protection for children between two and four years old — an age group in which two doses did not appear to provide enough protection. New data from this ongoing clinical trial is due in early April.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said recent data supplied by Pfizer prompted the agency to determine it needed to see data on a third dose before rescheduling its meeting. He did not specify what the new data received by the agency had shown.
“We take our responsibility for reviewing these vaccines very seriously because we’re parents as well,” he said. “Parents can feel reassured that we have set the standard by which we feel that if something does not meet that standard, we can’t proceed forward.”
Some experts had criticised the FDA’s request that Pfizer accelerate its application for emergency use authorisation, even though there were questions over the efficacy of its low-dose jab for children.
Sonja Rasmussen, professor at the University of Florida College of Medicine, said it is critical that the studies show the vaccine is not only safe, but that it is effective and that it works in this young age group.
“Parents need to know that the process for authorisation of the vaccine for their kids was thorough and that it demonstrated that the benefits of vaccination outweigh the potential risks,” she said. “If they feel that short-cuts were made, many parents will be reluctant to get their child vaccinated.”
David Dowdy, an epidemiologist at Johns Hopkins School of Medicine, said the delay made sense given that case rates in the US are declining rapidly and that new data on a three-dose regimen should be available in the next two months.