The drugmaker and partner BioNTech SE are expected to approach the Food and Drug Administration on Tuesday with a request to amend the existing emergency-use authorization and extend eligibility for a third-dose booster to everyone 18 and older, according to the people, who asked not to be identified as the data aren’t public.
The partners plan to share data from a more than 10,000-person late-stage study evaluating the safety and efficacy of a booster dose administered to participants who previously received two doses at least 6 months prior, said the people.
The late-stage clinical trial launched in the U.S., Brazil and South Africa among people 16 and older this past summer as cases caused by the delta variant surged. For now, Pfizer and BioNTech will only seek clearance for third doses for 18 and up, according to the people.
Pfizer shares were down 1.8% at 1:49 p.m. in New York on Tuesday. BioNTech’s American depositary receipts were down 5.1%.
Regulators first cleared a Pfizer booster shot in September for people 65 and older; individuals 18 to 64 who are at high risk of developing severe Covid-19; or adults whose work or living conditions put them at high risk of serious complications from the disease. The FDA and its advisers signed off on this decision after evaluating clinical trial data that showed the booster prompted a strong immune response. At the time, they didn’t have efficacy data in hand.
In late October, the vaccine partners shared early results from the 10,000-person trial demonstrating that the third-dose was 95.6% effective against symptomatic cases of Covid-19. Pfizer and BioNTech are the only companies to have reported efficacy data from a randomized trial of a booster shot.
The Pfizer-BioNTech vaccine regimen is initially given in two doses three weeks apart. The booster should be administered at least six months after the first round of injections, according to the FDA.
Booster shots could be a crucial tool for fending off a potential winter wave of infections. Regulators have authorized additional doses for all three of the vaccines available in the U.S., and experts have been especially focused on protecting more vulnerable groups such as the elderly and those with compromised immune systems.
Some 24.8 million Americans had received an additional Covid-19 shot as of Tuesday, according to the Centers for Disease Control and Prevention.
While the booster campaign has been ramping up, there are signs that a recent decline in infections is ending. Cases soared over the summer, fueled by the delta variant, and then declined through much of September and October. But now, cases are beginning to plateau, and public-health officials fear that the holiday season and colder weather could nurture a new wave of illness.
Pfizer had initially asked regulators for a broader clearance for boosters earlier in the year. But the emergency clearance granted by the FDA left the door open for consideration of wider use of the shots as more data on safety and efficacy became available.
