Drugmakers Pfizer and BioNTech said on Tuesday that they had asked the U.S. Food and Drug Administration (FDA) to authorize booster shots of their COVID-19 vaccine for all adults 18 years old and over, seeking to broaden who is eligible for a third shot, Trend reports citing Reuters.
The move came as part of a long-running debate among experts over who should be eligible for booster shots. An FDA advisory panel voted against a request for all adults to have a booster in September, in what was "a blow to the (Joe) Biden administration's earlier announcement of widespread shots," said The Hill.
Currently, people who get the Pfizer/BioNTech or Moderna COVID-19 vaccines six months ago or longer may get a booster if they are 65 or older; at risk of severe COVID-19 from a breakthrough infection because of a medical condition such as diabetes, kidney disease or pregnancy; or at risk because of living conditions or work.
The companies said the submission was based on results of a Phase 3 trial involving more than 10,000 participants. It found boosters were safe and had an efficacy of 95 percent against symptomatic COVID-19 compared with the two-dose vaccine schedule in the period when the highly transmissible Delta was the dominant strain.