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.
President Donald Trump's administration has ordered its missions abroad to stop scheduling new appointments for student visa applicants as the State Department prepares to expand social media vetting of foreign students.
Ukrainian President Volodymyr Zelenskyy landed in Berlin on Wednesday for talks with German Chancellor Friedrich Merz, his office said, part of a diplomatic drive to end the war in Ukraine, Europe's deadliest since World War Two.
Germany's foreign minister, Johann Wadephul, threatened unspecified measures against Israel on Tuesday and said Berlin would not export weapons used to break humanitarian law.
An explosion at a chemical plant in the eastern Chinese province of Shandong killed at least five people, with 19 injured and six missing, the state-run Xinhua agency said late on Tuesday.
The work of a US-backed private humanitarian organisation tasked with distributing aid in Gaza is a distraction from what is needed, such as the opening of crossing points, a UN spokesperson said on Tuesday.
The UAE has summoned the Israeli ambassador to the country, expressing strong condemnation over recent provocative actions against Palestinians in the compound of Al-Aqsa Mosque and the Muslim Quarter of the Old City in Jerusalem.