The FDA published a similar examination of Moderna’s vaccinations for youngsters under the age of six late last week.
Pfizer’s vaccine, given as a three-shot series, appeared 80% effective in preventing symptomatic COVID-19, although that calculation was based on just 10 cases diagnosed among study participants. The figure could change as Pfizer’s study continues.
The FDA released its review of the Pfizer vaccine ahead of a conference on Wednesday where independent experts will vote on whether the vaccines are safe for the nation’s 18 million newborns, toddlers, and preschoolers. In the United States, children under the age of five are the only ones who are not yet eligible for COVID-19 vaccine.
The FDA said children who received Pfizer’s shots during testing developed high levels of virus-fighting antibodies expected to protect them against coronavirus. That’s the basic threshold needed to win FDA authorization. But additional testing turned up key differences, with stronger results for Pfizer.