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.
Israeli Prime Minister Benjamin Netanyahu said on Sunday Israel would determine which foreign forces it would allow as part of a planned international force in Gaza to help secure an end to its war under US President Donald Trump's plan.
Two suspects in the brazen daylight heist of some of France's crown jewels from the Louvre were arrested in Paris on Saturday evening and are being questioned, Le Parisien newspaper reported on Sunday, citing sources close to the investigation.
Ukraine's President Volodymyr Zelenskyy called for new strong sanctions against Russia and its allies after Russian drones killed three and injured 31, including six children, in an overnight air attack on Kyiv.
The outlawed Kurdistan Workers Party (PKK) said on Sunday it was withdrawing from Turkey as part of a disarmament process it is coordinating with the government, and pressed Ankara for concrete measures to move the process along.