Data Show Pfizer/BioNtech’s COVID-19 Vaccine Safe and Nearly 91 Percent Effective in Kids 5 to 11 During Delta Surge

Pfizer/BioNtech’s pediatric vaccine was safe and 90.7 percent effective against symptomatic COVID-19 in children ages five to 11 even when up against the Delta variant over the summer.

That’s among the data submitted to the FDA by the companies in advance of their Oct. 26 meeting with the agency’s vaccine advisory committee to discuss an Emergency Use Authorization (EUA) for their much-anticipated 10-microgram, two-shot dose for children in that age group.

The trial included 2,250 children. The companies report that there were three COVID-19 cases among the group that got the vaccine and 16 cases in the placebo group. There were no cases of severe COVID-19 in the treatment group.

In the study, two-thirds of the kids got the vaccine, and one third got the placebo, the companies said. Pfizer and BioNTech announced positive results for the trial in September but didn’t divulge statistics (DID, Sept. 21).

In another group of almost 2,400 children 5 to 11, almost 1,600 of whom received the vaccine, all side effects were reported to be mild, including rashes and soreness where the shot was delivered. Children reported more side effects after the second dose than the first.

Pfizer and BioNTech filed for an EUA of their COVID-19 vaccine for children aged five to 11 years in early October. The next step is the FDA advisory panel meeting Oct. 26, then a vaccine advisory panel to the Centers for Disease Control and Prevention (CDC) will meet Nov. 2 and 3 to make a recommendation for use.

While awaiting those steps, the White House announced Oct. 21 that it had secured 28 million doses of Pfizer/BioNTech’s pediatric COVID-19 vaccine and plans to roll out the jabs for kids age five to 11 as soon as the FDA and CDC give the go-ahead for vaccines in that age group (DID, Oct. 21).

In partnership with states and localities, the administration said it will make vaccinations available at doctors’ offices in more than 25,000 pediatric offices and other primary care sites, and in 100 children’s hospitals, as well as schools, community health centers and rural health clinics.

Pfizer-BioNTech got an EUA for their COVID-19 vaccine in people age 16 and older in December 2020. In May, FDA authorized an amendment to the EUA to allow the vaccine to be given to kids age 12 and over. Since then, there has been much pressure on FDA to authorize the companies’ vaccine for younger kids, and much anticipation among parents and school systems.

Approximately 1.4 billion doses of Pfizer/BioNTech’s vaccine — which they named Comirnaty — have been distributed globally as of Aug. 31.

Read Pfizer’s briefing document for the FDA advisory committee here: www.fdanews.com/10-22-21-VRBPAC.pdf. — Suz Redfearn