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.
Portugal's authorities have said that between July 27 and August 15, 1,331 excess deaths from extreme heat were reported, with the over 75 age group particularly hard hit, Euronews reported on Saturday.
A tour bus carrying more than 50 people veered out of control and rolled over on an Upstate New York highway on Friday, killing at least five people and injuring dozens of others, authorities said.
Foreign ministers from European countries, Australia and Britain on Friday jointly condemned Israel's plans to construct a settlement east of Jerusalem.
Famine has struck an area of Gaza and will likely spread over the next month, a global hunger monitor determined on Friday, an assessment that will escalate pressure on Israel to allow more humanitarian aid into the war-torn Palestinian enclave.
North Korean leader Kim Jong Un lauded his country's "heroic" troops who fought for Russia in the war against Ukraine, in a ceremony where he decorated returning soldiers and consoled children of the bereaved with hugs, state media said on Friday.