Pfizer announced Monday morning that a Phase 2/3 trial showed that its COVID-19 vaccine is safe and that it generated a “robust” antibody response in kids ages 5-11. These are the first results on a COVID vaccine for this age group and the findings have been highly anticipated as parents wait to see when their young kids can get vaccinated. Still, it’s important to note that the data has not been peer-reviewed or published yet. Pfizer said it will submit its findings to the FDA and seek emergency use authorization soon.
The Pfizer trial consisted of 2,268 participants ages 5-11 and included a two-dose regimen, given 21 days apart. A key difference between the doses is that for those 12 and older a 30-microgram dose was used. The trial for the younger age group used a 10-microgram dose.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Pfizer said in a press release. “We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age,” said Pfizer.
The company also pointed out that a rise in pediatric COVID cases makes the need for a vaccine for this age group even more urgent. “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Pfizer and BioNTech said they plan to share data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.
The timeline for when the elementary school-aged kids will actually get shots is dependent upon the FDA’s emergency use approval. Results of testing for the under-5 age group are expected later this year.