© 2026 ABC News

\"... the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said in a statement. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”

Along with Pfizer, Moderna and Johnson & Johnson's COVID-19 vaccines were previously given emergency use authorization.

Moderna announced Thursday that it plans to start the BLA process later in May.

Companies were always expected to formally submit for approval, rather than emergency authorization, once they hit the six-month safety requirement.

As more Americans get vaccinated and cases decline in the U.S., the Centers for Disease Control and Prevention has updated its guidelines for mask-wearing outdoors, small group gatherings and more. Many states and cities have also quickly reversed strict lockdown policies. In New York, Gov. Andrew Cuomo announced the easement of most restrictions, while New York City Mayor Bill de Blasio said he expects the city to be fully open by July 1.

\"After a long and incredibly difficult fight, New York state is winning the war against COVID-19, and that means it's time to loosen some restrictions put in place to protect the public health and help our local businesses,\" Cuomo said last week.

Since the pandemic began, more than 32 million Americans have been diagnosed with COVID-19, according to a count kept by Johns Hopkins University. Of those, at least 580,061 deaths have been reported.

","canonicalUrl":"https://abcnews.com/Health/pfizer-seeks-full-fda-approval-covid-19-vaccine/story?id=77549532","legacySlug":"/wellness/story/pfizer-seeks-full-fda-approval-covid-19-vaccine-77549532","noIndexNoFollow":false},"publishTime":"10:45","publishDate":"05-07-2021","updatedTime":"17:41","updatedDate":"05-08-2021","socialImage":{"alt":"FILE PHOTO: FILE PHOTO: A medical worker prepares a dose of the \"Comirnaty\" Pfizer-BioNTech COVID-19 vaccine inside the exhibition palace transformed into a vaccination center in Nice as part of the coronavirus disease (COVID-19) vaccination campaign in France, April 29, 2021.","credit":"Eric Gaillard/Reuters","ratio":"16x9","url":"https://s.abcnews.com/images/US/Pfizer-FDA-210_hpMain_20210507-031349_16x9_1600.jpg","width":992,"height":558},"datePublished":"5/7/2021 10:45:00 GMT","video":{"live":false,"id":77549532,"headline":"Pfizer seeks full FDA approval for COVID vaccine","mediaAssetTitle":"PFIZER FDA","description":"The company said it has delivered more than 170 million doses in the U.S.","duration":"2:58","posterImg":{"url":"https://s.abcnews.com/images/GMA/default-img-undefined.png","width":608,"height":342},"video":{"feed":"https://service-pkgabcnews.akamaized.net/opp/hls/abcnews/2021/05/210508_gma_ashton_805_,500,800,1200,1800,2500,3200,4500,.mp4.csmil/playlist.m3u8"},"playlist":["135219568","135145820","134977845"]},"relatedItems":[{"contentType":"video","date":"July 30, 2026","headline":"US launches new retaliatory strikes on Iran after attack on US forces","section":"News","slug":"/video/135219568","id":"135219568","image":{"alt":"VIDEO: US launches new retaliatory strikes on Iran after attack on US forces","credit":"ABCNews.com","ratio":"1x1","url":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_1x1_608.jpg","width":384,"height":384},"images":{"alt":"VIDEO: US launches new retaliatory strikes on Iran after attack on US forces","credit":"ABCNews.com","crops":[{"16x9":{"small":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_16x9_608.jpg","medium":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_16x9_992.jpg","large":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_16x9_1600.jpg"}},{"9x16":{"small":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_9x16_608.jpg","medium":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_9x16_992.jpg","large":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_16x9_1600.jpg"}},{"1x1":{"small":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_1x1_608.jpg","medium":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_1x1_992.jpg","large":"https://s.abcnews.com/images/GMA/260730_gma_scott_iran3_hpMain_1x1_1600.jpg"}}]}},{"contentType":"video","date":"July 28, 2026","headline":"Tornadoes touch down as severe storms sweep East","section":"News","slug":"/video/135145820","id":"135145820","image":{"alt":"VIDEO: Tornadoes touch down as severe storms sweep East","credit":"ABCNews.com","ratio":"1x1","url":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_1x1_608.jpg","width":384,"height":384},"images":{"alt":"VIDEO: Tornadoes touch down as severe storms sweep East","credit":"ABCNews.com","crops":[{"16x9":{"small":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_16x9_608.jpg","medium":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_16x9_992.jpg","large":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_16x9_1600.jpg"}},{"9x16":{"small":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_9x16_608.jpg","medium":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_9x16_992.jpg","large":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_16x9_1600.jpg"}},{"1x1":{"small":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_1x1_608.jpg","medium":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_1x1_992.jpg","large":"https://s.abcnews.com/images/GMA/260728_gma_perez_tornadoes2_703_hpMain_1x1_1600.jpg"}}]}},{"contentType":"video","date":"July 22, 2026","headline":"Malcolm-Jamal Warner's widow sues his mother after drowning death","section":"News","slug":"/video/134977845","id":"134977845","image":{"alt":"VIDEO: Malcolm-Jamal Warner's widow sues his mother after drowning death","credit":"ABCNews.com","ratio":"1x1","url":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_1x1_608.jpg","width":384,"height":384},"images":{"alt":"VIDEO: Malcolm-Jamal Warner's widow sues his mother after drowning death","credit":"ABCNews.com","crops":[{"16x9":{"small":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_16x9_608.jpg","medium":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_16x9_992.jpg","large":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_16x9_1600.jpg"}},{"9x16":{"small":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_9x16_608.jpg","medium":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_9x16_992.jpg","large":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_16x9_1600.jpg"}},{"1x1":{"small":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_1x1_608.jpg","medium":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_1x1_992.jpg","large":"https://s.abcnews.com/images/GMA/260722_gma_norwood_warner1_734_hpMain_1x1_1600.jpg"}}]}}],"relatedContentSection":"news","schemaContent":{"name":"Pfizer seeks full FDA approval for COVID vaccine","description":"The company said it has delivered more than 170 million doses in the U.S.","duration":"2:58","uploadDate":"05-07-2021","publication":"05-07-2021","images":"https://s.abcnews.com/images/GMA/default-img-undefined.png","url":"https://service-pkgabcnews.akamaized.net/opp/hls/abcnews/2021/05/210508_gma_ashton_805_,500,800,1200,1800,2500,3200,4500,.mp4.csmil/playlist.m3u8","contentUrl":"https://service-pkgabcnews.akamaized.net/opp/hls/abcnews/2021/05/210508_gma_ashton_805_,500,800,1200,1800,2500,3200,4500,.mp4.csmil/playlist.m3u8","link":"https://www.goodmorningamerica.com/news/story/pfizer-seeks-full-fda-approval-covid-19-vaccine-77549532"}},"playlist":[{"id":"135222489","contentType":"story","section":"news"},{"id":"135236246","contentType":"story","section":"news"},{"id":"135259626","contentType":"story","section":"news"},{"id":"135189298","contentType":"story","section":"news"},{"id":"135195168","contentType":"story","section":"news"},{"id":"134926667","contentType":"story","section":"news"},{"id":"135120534","contentType":"story","section":"news"},{"id":"134959102","contentType":"story","section":"news"},{"id":"134910526","contentType":"story","section":"news"},{"id":"134846473","contentType":"story","section":"news"},{"id":"134848966","contentType":"story","section":"news"},{"id":"134761751","contentType":"story","section":"news"},{"id":"134787741","contentType":"story","section":"news"},{"id":"134782596","contentType":"story","section":"news"},{"id":"134741027","contentType":"story","section":"news"},{"id":"134751717","contentType":"story","section":"news"},{"id":"134708317","contentType":"story","section":"news"},{"id":"134548164","contentType":"story","section":"news"},{"id":"134542058","contentType":"story","section":"news"},{"id":"134416060","contentType":"story","section":"news"}],"kvps":{"pgtyp":"article","lang":"en","sp":"goodmorningamerica","programmatic":"true","bundleId":"com.abcnews"}},"analytics":{"accountID":"wdgnewwdgnewgmaweb","ns":"gma","pageName":"gma:news:video","pageType":"video","globalSpecVersion":"v1.08","siteDifferentiator":"gma:site","tagID":"g_page01","userABCookie":"0","section":"news","title":"Pfizer seeks full FDA approval for COVID vaccine","pubTime":"06:45","pubDate":"05-07-2021","modTime":"13:41","modDate":"05-08-2021","taxonomyTags":"none","id":77549532,"editorialOtherSubjects":"","wordCount":"none","columns":"none","authors":"","authorsUnit":"none","authorsBureau":"none","subBrand":"Good Morning America","provider":"Good Morning America","videoName":"Pfizer seeks full FDA approval for COVID vaccine","mediaAssetTitle":"PFIZER FDA","videoId":77549532,"mediaOnPage":"video","legacySlug":"/wellness/story/pfizer-seeks-full-fda-approval-covid-19-vaccine-77549532"},"taboola":{}},"request":{"headers":{},"httpVersion":"1.1","method":"GET","url":"/video/77549532","vary":{"host":"www.goodmorningamerica.com","cached":true,"path":"/video/77549532","forwarded-proto":"https","device":"desktop","userab":"0"}},"viewport":{"width":1260,"height":0},"user":{}};