A federal official said anonymously that the Pfizer-BioNTech COVID-19 vaccine could receive 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 should change the current EUA, but if granted it would be the first COVID-19 vaccine allowed to be used in this age group.
In late March, Pfizer reported topline data in a Phase 3 study in the United States involving 2,260 participants 12-15 years old. The participants were split into two cohorts with one of them receiving a two-dose vaccine (n = 1131) or a placebo (n = 1129) for the prevention of COVID-19.
The results showed that no one in the vaccine cohort had the virus and 18 cases of COVID-19 were confirmed in the cohort that received placebo.
This data in this smaller trial formed the basis for Pfizer-BioNTech to apply for the EUA a few weeks ago.
“We share the urgency to expand the authorization of our vaccine for use in younger populations and are encouraged by the data from clinical trials of adolescents between the ages of 12 and 15,” said Pfizer Chairman and CEO Albert Bourla at the time, the topline. results were released. “We plan to submit this data to the FDA in the coming weeks as a proposed amendment to our Emergency Use Authorization, and to other regulators around the world, hoping to vaccinate this age group before the start of the next school year. . “
In addition, Moderna announced in March that it would conduct a phase 2/3 open-label study, testing the mRNA-1273 vaccine in children 6 months to 12 years of age.
The company wants to enroll up to 6,750 healthy participants. For the first part of the study, a dose increase and age decrease phase, participants between the ages of 2 and 12 receive one of two dose levels (50 μg or 100 μg) of the vaccine, and each participant aged 6 months to less than 2 year 1 of 3 dose levels can be administered (25 μg, 50 μg and 100 μg).
After the first part of the study, researchers will conduct an analysis to determine what dose t will be used in the second part of the study. This will be a placebo-controlled expansion portion.
Novavax also announced yesterday that it would begin its own pediatric trial with a phase 2/3 trial involving up to 3,000 participants 12-17 years old. The company plans to give participants either the NVX-CoV2373 COVID-19 vaccine from Novavax or a placebo with 2 doses each given 21 days apart.