Pfizer seeks full approval for virus vaccine in US
Application to FDA is key step toward wider use of shot
Pfizer and the German company BioNTech have become the first companies to apply to the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine for use in people 16 and older. The vaccine is currently being administered to adults in the U.S. under an emergency use authorization granted in December.
The approval process is likely to take months.
The companies said in a statement Friday that they submitted their clinical data, which includes six months of information on the vaccine’s safety and efficacy, to the FDA. They plan to submit additional material, including information about manufacturing the vaccine, in the coming weeks.
“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,” Dr. Albert Bourla, Pfizer’s CEO, said in the statement. “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.”
As of Thursday, more than 134 million doses of the vaccine had been administered in the United States, according to the Centers for Disease Control and Prevention. Full approval would allow Pfizer and BioNTech to market the vaccine directly to customers.
It could also make it easier for companies, government agencies and schools to require vaccinations. The Equal Employment Opportunity Commission said in December that employers could mandate vaccination, and legal experts have generally agreed.
Many companies have been hesitant to require the vaccines, especially while they have only emergency authorization, which is designed to be temporary. Some institutions, like the University of California and California State University systems, have said that they would do so only after a vaccine has full approval.
Full approval could also prompt the U.S. military, which has had low uptake of COVID-19 vaccines, to mandate vaccinations for service members.
If the FDA grants full approval, it could also help raise confidence in the vaccine. The pace of vaccination has slowed in the United States in recent weeks, and a recent national survey indicated that most people in the country who planned to get the shots had already done so.
The agency is also expected to issue an emergency authorization for use of the Pfizer-BioNTech vaccine in 12- to 15-year-olds next week. The companies have said that they plan to file for emergency authorization for 2- to 11-year-olds in September.
Moderna plans to apply for full approval for its COVID-19 vaccine this month, the company said during its quarterly earnings call Thursday.
The Pfizer-BioNTech vaccine was designed using messenger RNA technology. It works by instructing cells in the body to generate the spike protein that initiates the coronavirus infection, spurring an immune response.
On April 1, Pfizer and BioNtech reported follow-up data from a finalstage trial of 46,307 people showing the vaccine was 91.3% effective in preventing symptomatic cases starting one week after the second dose for as long as six months. In the U.S. alone, the efficacy rate was 92.6%.
Countries around the world are now reporting real-world data showcasing that the vaccine might handle variants. In Qatar, for example, the two-shot regimen proved to be nearly 90% effective at preventing infection with B.1.1.7, and about 75% against the B.1.351 strain, according to analysis run on a national database of more than 200,000 people.
BioNTech Chief Executive Officer Ugur Sahin has said those who have been fully vaccinated will still likely need a booster shot of the same formulation in six to nine months. The company has begun evaluating an updated formulation specific to the variant first detected in South Africa.
Pfizer and BioNTech aim to make 3 billion doses in 2021, much of which has already been purchased by governments around the world. Through year-end, Pfizer expects the vaccine to yield $26 billion in sales. Half of the profits will go to BioNTech.
Looking forward, however, Pfizer executives envision commercializing the COVID vaccine much like a seasonal flu shot. The New York-based drugmaker and its German partner said they can make more than 3 billion doses in 2022, and are already clinching multiyear supply agreements with governments that would allow them to continue to boost protection as immunity wanes and new virus mutations emerge.
Once the pandemic has subsided, Pfizer plans to raise the price of the shot, Chief Financial Officer Frank D’Amelio told investors in February. The U.S. government paid $19.50 per dose, or $39 for the full regimen. “Obviously, that’s not a normal price like we’d typically get for vaccine,” he said. “We’re going to get more on price.”