Pfizer requests full-approval from the FDA
The vaccine would become the first in the nation to be approved for direct-to-consumer distribution.
By Matthew Royer, Staff Writer
Vaccine distributors Pfizer and BioNTech have taken a leap towards the light at the end of the tunnel as they officially request full-approval from the FDA for their COVID-19 vaccine.
After a week that saw the United States back a waiver of IP protection for COVID-19 vaccines, vaccine manufacturer Pfizer requested their full-approval for their two-shot vaccine, as well as emergency approval for use on children aged 12-15, according to Politico.
While full-approval is still under consideration by the FDA, usage of the vaccine for adolescents was approved and officially recommended by the government organization on May 11, and later by the CDC for clinical use on May 12.
In a press release marking the request, Pfizer CEO Albert Bourla provided confidence in the company’s approach.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Bourla. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
The request comes as the CDC reports that nearly 50 percent of the United States’ population has received at least one dose of the three emergency-approved vaccines. In California, the state has reached the highest vaccination rates in the country, with 62.3 percent of the population partially vaccinated, according to the state’s vaccination database.
Los Angeles County in particular is leading the charge, entering the least restrictive yellow tier last week in the state’s four-tier blueprint system. This follows as the county has opened each manufacturer’s vaccine to the general public, allowing anybody who wants to be vaccinated a chance to do so.
Los Angeles Mayor Eric Garcetti tweeted words of guidance for Angelenos as the city and state push for more individuals to be vaccinated.
“The vaccine is free, safe and effective,” wrote Garcetti. “Now is the time to encourage friends and family to get vaccinated. Together, we can defeat COVID-19.”
With Pfizer officially looking for the final approval from the CDC, other vaccine manufacturers such as Moderna and Johnson & Johnson are also looking to request full approval from the FDA within the next few weeks, according to the American Hospital Association.