The US Food and Drug Administration on Monday gave full approval to the COVID-19 vaccine made by Pfizer and German partner BioNTech for use in people over the age of 16.
It's the first such approval of a COVID-19 shot.
The vaccine has been authorised for emergency use since December and more than 204 million people in the United States have received it, based on Sunday's data.
But none of the three authorised COVID-19 vaccines had previously received full FDA approval.
Public health officials hope it will convince more unvaccinated Americans that Pfizer's shot is safe and effective.
Vaccine hesitancy among some Americans has hindered the United States response to the novel coronavirus.
"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," said Janet Woodcock, the US Food and Drug Administration's acting commissioner.
Roughly 51 per cent of Americans have been fully vaccinated so far, even as a recent surge of infections spurred by the contagious Delta variant ravages parts of the country with low vaccination rates.
Russia has opened a criminal case against Ukrainian President Volodymyr Zelenskiy and put him on a wanted list, the state news agency TASS reported on Saturday, citing the Interior Ministry's database.
The death toll from rains in Brazil's southernmost state of Rio Grande do Sul rose to 56, local authorities said on Saturday morning, while dozens still have not been accounted for.
Hamas has said it is sending a delegation to Cairo on Saturday to discuss a deal for a truce and the release of hostages in Gaza, hours after US CIA Director William Burns arrived in the Egyptian capital, according to Egyptian sources.
NATO's four-month long military exercises near Russia's borders, known as Steadfast Defender, are proof the alliance is preparing for a potential conflict with Russia, a spokeswoman for Russia's Foreign Ministry said on Saturday.
Students at Trinity College Dublin protesting Israel's war in Gaza have built an encampment that forced the university to restrict campus access on Saturday and close the Book of Kells exhibition, one of Ireland's top tourist attractions.
The President His Highness Sheikh Mohamed bin Zayed Al Nahyan has received condolences from regional leaders on the death of his uncle, Sheikh Tahnoun bin Mohammed Al Nahyan.