DETROIT – Pfizer is asking the Food and Drug Administration for full approval of its coronavirus vaccine.
The vaccine was granted an emergency use authorization in December for use in those 16 years old and older.
If the FDA grants the request for full approval, the Pfizer vaccine would become the first vaccine to be fully approved in the United States.
“It will certainly be an important day if full approval is granted. but the process will be fully lead and run by the FDA,” said White House COVID-19 Response Coordinator Jeffrey Zients.
Pfizer and its partner, BioNTech, have submitted six months of data on the vaccine’s safety and efficacy. Over the next few weeks, they will submit additional information on manufacturing processes and facilities. The full FDA review is expected to take months.
A full approval would allow Pfizer to market the vaccine directly to the public and expand distribution beyond the federal program. It would also make it easier for companies, agencies and schools to mandate the vaccine, but it would likely boost confidence in the vaccine’s safety as well.
The approval application only covers those 16 and up as there needs to be more data on younger ages. Pfizer has requested a separate expansion of its emergency use authorization to include children between the ages of 12-15.
“Should the FDA issue an emergency use authorization of the Pfizer vaccine for individuals ages 12 to 15, we already have in place the operational public education plan to immediately hit the ground running,” Zients said. “Over 15,000 local pharmacies will be ready to vaccinate 12- to 15-year-olds. And we are working to get more pediatricians and family doctors to offer vaccinations in their offices to make it as easy and convenient for adolescents to get vaccinated.”
More than 134 million doses of Pfizer have already been administered in the United States.
Moderna also plans to apply for full approval for its COVID vaccine later in May.