Pfizer-BioNTech Release Favorable Results of COVID-19 Vaccine Study in 5- to 11-Year- Olds, Possibly Calming Turmoil at FDA

Pfizer-BioNTech’s COVID-19 vaccine for kids age five to 11 years appears ready for prime time as the first results from the companies’ trial of a COVID-19 vaccine in this age group are released.

The companies said they plan to submit the data to the FDA, European Medicines Agency (EMA) and other regulatory agencies around the world as soon as possible. Pfizer-BioNTech expect to include the data in a near-term submission to the FDA for Emergency Use Authorization as they continue to accumulate the safety and efficacy data required to file for full FDA approval for the age group. A request to the EMA to update the EU Conditional Marketing Authorization is also planned.

The companies on Monday announced that their study of a lower-dose version of the vaccine has shown a favorable safety profile and robust neutralizing antibody responses in 5- to 11-year-olds using a two-dose regimen of 10 micrograms (mcgs) administered 21 days apart. People 12 years and older get a 30-mcg dose.

Pfizer-BioNTech said the antibody responses in the participants given 10-mcg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age who were immunized with 30-mcg doses. The trial included 2,268 children ages five to 11 years, two-thirds of whom received two doses. The other one-third got placebo. 

This could be good news for the FDA, which has been under pressure to approve a COVID-19 vaccine for kids as well as to approve booster shots for the general public. Last week, an FDA advisory panel voted down the Pfizer-BioNTech vaccine booster for the general public, saying it needed to see more evidence that a booster is needed. This, just days before the Biden administration said it wanted to begin administering booster doses to the general public (DID, Sept. 20). However, the panel did recommend the booster shots for those over age 65 years and people at high risk of severe disease.

Amid the turmoil of the past few weeks, FDA lost two of its high-ranking vaccine officials. Marion Gruber, director of the FDA’s Office of Vaccines Research & Review (OVRR), who has been with the agency for 32 years, announced she plans to retire on Oct. 31, while Phil Krause, deputy director of OVRR, who has served with the agency for more than 10 years, said he will depart in November (DID, Sept. 1).

The positive data on kids five to 11 years appear to clear the path for FDA to approve Pfizer-BioNTech’s vaccine in kids, which parents and school systems have been clamoring for.

Pfizer-BioNTech’s results are the first from a clinical trial of any COVID-19 vaccine in children under 12 years of age.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination,” said Albert Bourla, chairman and CEO of Pfizer. “These trial results provide a strong foundation for seeking authorization of our vaccine for children five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”

In addition to working well, the vaccine was well-tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age, said Pfizer-BioNTech.

Results for the other two age cohorts from the trial — children two to five years of age and children six months to two years old — are expected as soon as the fourth quarter of this year, the companies said. — Suz Redfearn