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.
US President Donald Trump has issued a fresh warning to Iran, saying “the clock is ticking” as tensions continue to rise between Washington and Tehran.
Israeli strikes killed at least five Palestinians in the Gaza Strip on Sunday, health officials said, as ceasefire efforts meant to end fighting between Israel and Hamas falter.
An Ebola outbreak in the Democratic Republic of Congo and Uganda has been declared a public health emergency of international concern by the World Health Organisation, after 80 suspected deaths and nine laboratory-confirmed cases.
At least four people were killed, including three in the Moscow region, after Ukraine launched its biggest overnight drone attack on the Russian capital in more than a year, local officials said on Sunday.
US President Donald Trump said on Friday that Abu-Bilal al-Minuki, second in command of ISIS globally, was killed in an operation conducted by US and Nigerian forces.
The United Arab Emirates has condemned in the strongest terms the unprovoked attack targeting an electricity generator outside the inner perimeter of the Barakah Nuclear Power Plant in Al Dhafra region, carried out by a drone that entered the country’s territory from the western border.
His Highness Sheikh Abdullah bin Zayed Al Nahyan, Deputy Prime Minister and Minister of Foreign Affairs, has discussed the drone strike near the Barakah nuclear power plant with several Arab foreign ministers during a series of phone calls on Sunday.
The UAE Fatwa Council has announced that Eid Al Adha will begin on Wednesday, May 27, after confirming the sighting of the Dhu al-Hijjah crescent moon on Sunday evening.