Pfizer-BioNTech COVID-19 Vaccine May be Granted FDA EUA for Pediatric Population Soon

A federal official anonymously said the Pfizer-BioNTech COVID-19 vaccine may receive an FDA Emergency Use Authorization for the 12-15 year old population as early as next week according to a news report on CNN.

The FDA would need to amend the current EUA, but if it is granted, this would be the first COVID-19 vaccine allowed to be used in this age group.

At the end of March, Pfizer reported topline data in a phase 3 trial in the United States that included 2260 participants aged 12-15 years old. The participants were broken up into two cohorts with one of them administered a two-dose vaccine (n = 1131) or were given a placebo (n = 1129) for the prevention of COVID-19.

Results demonstrated no one in the vaccine cohort had the virus and 18 cases of COVID-19 were confirmed in the cohort that was administered placebo.

This data in this smaller trial was the basis for Pfizer-BioNTech to apply for the EUA a few weeks back.

“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Pfizer Chairman and CEO Albert Bourla, said at the time the topline results were released. “We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”

In addition, Moderna announced back in March it would be conducting a phase 2/3 open label trial, testing its mRNA-1273 vaccine in children aged 6 months up to 12 years.

The company wants to enroll up to 6750 healthy participants. For the first part of the study, a dose-escalation, age de-escalation phase, participants between the ages of 2 and 12 will receive one of two dose levels (50 μg or 100 μg) of the vaccine, and each participant aged 6 months to less than 2 years may receive 1 of 3 dose levels (25 μg, 50 μg and 100 μg).

After the first part of the trial, investigators will conduct an analysis to determine determine which dosage t will be used in the second part of the study. This will be a placebo-controlled expansion portion.

Novavax also announced yesterday it was going to begin its own pediatric trial with a phase 2/3 trial with up to 3000 participants aged 12-17 years old. The company plans to either give the participants Novavax’s investigational NVX-CoV2373 COVID-19 vaccine or administer a placebo using 2 doses with each given 21 days apart.