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 expanded a list of countries subject to a full travel ban on Tuesday, prohibiting citizens from an additional seven countries, including passports from Syria and Palestine, from entering the United States.
The alleged gunman shot dead by police during Sunday's attack on Australia's Bondi beach was originally from the southern Indian city of Hyderabad and his family did not know about his 'radical mindset', Indian police said on Tuesday.
US President Donald Trump has ordered on Tuesday a "blockade" of all sanctioned oil tankers entering and leaving Venezuela, in Washington's latest move to increase pressure on Nicolas Maduro's government, targeting its main source of income.
The Israeli military have shot dead a 16-year-old Palestinian during a raid on the town of Tuqu' on Monday, the Palestinian health ministry said, the latest deadly incident in a recent surge of violence in the Israeli-occupied West Bank.
US President Donald Trump has sued the BBC on Monday for defamation over edited clips of a speech that made it appear he directed supporters to storm the US Capitol, opening an international front in his fight against media coverage he deems untrue or unfair.