Pfizer, Moderna win FDA backing for COVID shots in kids ahead of AdCom review
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The U.S. Food and Drug Administration (FDA) has issued favorable remarks on the COVID-19 vaccines developed by Pfizer (NYSE:PFE)/BioNTech (BNTX) and Moderna (MRNA) for younger children as a group of independent experts of the agency plans to meet this week to review data.
Three doses of Pfizer (PFE)/BioNTech (BNTX) vaccine were safe and effective for the prevention of symptoms in children aged 6 months through 4 years, the FDA staffers wrote in briefing documents released on Sunday.
âGiven the uncertainty of the Covid-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on Covid-19 associated morbidity and mortality in this age group,â they added.
On Friday, the FDA reviewers said in a separate set of briefing documents that the two doses of the Moderna (MRNA) vaccine worked well with no safety concerns in studies for children aged 6 months through 5 years old.
The panelists are expected to review the data for both vaccines on June 15. The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
If the FDA greenlights the vaccines, a separate panel of the Centers for Disease Control and Prevention (CDC) is expected to weigh the results. Once the CDC clears the shots, a nationwide rollout of the vaccines can begin.
Early this month, White House Coronavirus Response Coordinator Ashish Jha said that the COVID immunization drive for children under the age of 5 could begin as soon as June 21.