In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines and Related Biological Products Advisory Committee meeting.
Pfizer and BioNTech, like Moderna (Nasdaq:MRNA), are seeking emergency use authorization (EUA) to use their respective vaccines in children aged six months to four years of age.
Pfizer has provided FDA with new reactogenicity and immunogenicity data from the ongoing Phase 1/2/3 C4591007 trial.
In late May, Pfizer submitted a request to FDA to allow the use of three 3-μg doses of their BNT162b2 vaccine in the same demographic.
In April, Moderna announced that it had filed paperwork seeking EUA for two 25-μg doses of its mRNA-1273 vaccine in young children.
Pfizer had initially intended to seek authorization for two doses of their vaccine in young children but amended the protocol after an analysis following administration of the second dose.
There are approximately 18 million children in the U.S. under 5 years old.
“Given 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,” FDA concluded in the analysis.
The agency also noted that the vaccine has proven effective in older pediatric age groups.
In its analysis, FDA noted there are limited data available related to the Pfizer-BioNTech vaccine’s performance in children six months through 4 years of age but that the rate of adverse events in the C4591007 vaccine was lower than in older individuals.
PFE shares were down 2.78% to $48.58, while BNTX shares fell 6.04% to $135.13 in mid-day trading. For comparison, MRNA shares were down 7.09% to $118.17.