The antivirals stop the virus from replicating, so they work best if given to COVID-19 patients who are early in their illness when their symptoms are still mild.
The Pfizer treatment could help keep people infected with the coronavirus from getting so sick that they need to be hospitalized.
The companies say the request is based on results from a study of more than 10,000 volunteers that show vaccine efficacy of 95% or greater for people receiving the booster.
The company says it will stop enrolling people into more clinical trials for the pill and will instead send the results it has so far to the FDA.
Boosters are available to a much broader range of individuals, and that the types of vaccines people can get are more diverse.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” the pharmaceutical giant said.
The pledge will come at the start of a virtual summit aimed at boosting commitments from other nations and the private sector. The goal: vaccinate 70% of the world’s population within a year.
By NPR Pfizer and BioNTech’s trials for the COVID-19 vaccine for children under 12 showed the shots are safe for children and establish a strong antibody response against the virus.
The agency typically follows the advice of its advisory committees, though it isn’t required to.
The FDA announced the Pfizer vaccine is the first in the U.S. that is now fully approved. Here’s what that means for vaccine mandates and convincing vaccine-hesitant people to get vaccinated.
