Pfizer-BioNTech’s Expanding Coronavirus Vaccine FDA Approval

Late last month, Pfizer announced its coronavirus vaccine clinical trial results, indicating that a three-dose regimen of the Pfizer-BioNTech vaccine was safe and effective for children older than 6 months and younger than 5 years of age.

The clinical trial utilized two endpoints to measure the vaccine’s effectiveness. The primary endpoint in this study was topline safety, and the secondary endpoint was vaccine efficacy. Conclusions about safety and efficacy were drawn after 1,678 children under the age of 5 received three doses of a vaccine 10% the strength of the adult version.

Around the time they announced the successful trial, Pfizer was granted FDA approval to go to market with a booster dose of their vaccine for children aged 5–11. And recently, in March of this year, the FDA approved a fourth shot of the vaccine (second booster) for certain groups aged 12 and older.

The FDA’s most recent clinical trial attempts to rectify its past rebuff from the FDA after the administration did not approve a two-dose vaccine for toddlers because of lacking clinical trial evidence. The current three-dose trial involves 10,000 children from four different countries.

Pfizer-BioNTechs initial emergency use authorization (EUA) came 18 months ago, in December of 2020, and in August 2021, the vaccine received full FDA approval.

While Pfizer-BioNTech’s vaccine has enjoyed broad approval from the FDA, Moderna’s ‘Spikevax’ is still only approved for individuals 18 years of age and older. In April, Moderna filed an EUA to go to market with a vaccine for children aged 6 months and older based on clinical trial results that showed efficacy against the Omicron variant. Moderna’s version of the coronavirus vaccine received full FDA approval in February of this year.

Moderna’s phase 2 and 3 trials studied the effect of vaccines on 13,575 patients versus the 10,000 patients studied with Pfizer’s vaccine trial. Both studies viewed safety as the primary outcome measure for effectiveness.

Data indicate that children weather a COVID-19 infection far better than older people. State data finds that less than 1.5% of childhood infections result in hospitalization, and a far lower number results in death. Children are also less likely to show symptoms when infected with COVID-19.

If Pfizer and Moderna received FDA approval for their vaccinations, these would expand the limited supply of treatments and preventatives available for coronavirus treatment in children. Currently, the only recommended medications to treat children for coronavirus are Remdesivir and dexamethasone in cases that require high-flow oxygen.