Pfizer, BioNTech Seeks Full US Approval For Covid Vaccine.

Pfizer, BioNTech Seeks Full US Approval For Covid Vaccine

The companies are now seeking a "Biologics License Application" for permanent regulatory approval (File)

New York:

Pfizer and BioNTech said Friday they were launching an application requesting full US regulatory approval for their game-changing Covid-19 vaccine for individuals 16 years and older.

The two pharma companies plan to submit data in support of the application "on a rolling basis over the coming weeks" to the Food and Drug Administration (FDA), they said in a press release.

The FDA approved the vaccine in December for emergency use, a designation permitted during public health emergencies. Since then, more than 170 million doses of the vaccine have been delivered in the United States.

The companies are now seeking a "Biologics License Application" for permanent regulatory approval, which "requires longer-term follow-up data for acceptance and approval," the companies said.

The information will include data on the vaccine efficacy and safety profile up to six months after the second dose in a phase-three clinical trial.

"We are proud of the tremendous progress we've made since December in delivering vaccines to millions of Americans, in collaboration with the US government," said Pfizer Chief Executive Albert 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."

Pfizer and BioNTech have also submitted data to garner emergency use approval for individuals 12 to 15 years old. Pfizer said earlier in the week that it expects imminent US approval for this application.

(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)

NDTV News

NDTV.com provides latest news from India and the world. Get today’s news headlines from Business, Technology, Bollywood, Cricket, videos, photos, live news coverage and exclusive breaking news from India.

https://www.ndtv.com/

Related news

«Small» Groups Don't Rule The World: China Cautions G7.

China on Sunday pointedly cautioned Group of Seven leaders that the days when "small" groups of countries decided the fate of the world was long gone, hitting back at the world's richest democracies...

NDTV News

Kat Timpf rips Fauci as 'completely insane' after latest comments.

Kat Timpf rips Fauci as 'completely insane' after latest comments.

'Gutfeld!' panel react to the top doctor saying an attack on him is an 'attack on science.' #FoxNews #Gutfeld Subscribe to Fox News! Watch more Fox News Video: Watch Fox News Channel Live: FOX News Channel (FNC) is a 24-hour all-encompassing news ...

Covid Unemployment Benefits Ending In Some U.S. States This Week

Covid Unemployment Benefits Ending In Some U.S. States This Week

Alaska, Iowa, Missouri and Mississippi will soon cut off federal Covid-19 unemployment benefits to those out-of-work. The states are backing out of the pandemic programs almost three months early. NBC News' Ben Popken reports.» Subscribe to NBC Ne...

How A 2013 SCOTUS Ruling Cleared A Path For Restrictive Voting Laws.

How A 2013 SCOTUS Ruling Cleared A Path For Restrictive Voting Laws.

Congress will begin hearing arguments on the John Lewis Voting Rights Act this week. The act brings back portions of the Voting Rights Act of 1965 the Supreme Court struck down in 2013 that impacted millions of non-white voters. NBC News’ Priscill...

Vaccinated people 'should enjoy greater freedoms' - Tony Blair.

Vaccinated people 'should enjoy greater freedoms' - Tony Blair.

Former Prime Minister Tony Blair has told Sky News there should be "a distinction between the vaccinated and unvaccinated". Mr Blair believes there's a benefit in vaccine passports and wants vaccinated people to be given "greater freedoms". SUBSCR...

G7 to pledge 1 billion vaccines for global rollout - DW News.

G7 to pledge 1 billion vaccines for global rollout - DW News.

World leaders gathering in south west England will announce a plan to help vaccinate poorer countries by the end of next year. At the G7 summit in Cornwall, they will pledge to provide one billion doses of Covid-19 vaccines. The move aims to addre...

BREAKING: Delta variant 60% more transmissible & more vaccine resistant.

BREAKING: Delta variant 60% more transmissible & more vaccine resistant.

Public Health England has revealed that the Delta (Indian) variant is about 60% more transmissible than the Alpha (Kent) variant and vaccines are less effective against it. SUBSCRIBE to our YouTube channel for more videos: Follow us on Twitter: Li...