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.
The Kuwaiti Ministry of Foreign Affairs has handed a formal protest note to Iran’s acting chargé d’affaires in the country, addressing the continued Iranian missile and drone attacks.
An Iranian drone and missile attack struck Kuwait's international airport, forcing authorities on Wednesday to suspend air traffic and divert flights to nearby airports until further notice.
The Israeli military said it had intercepted rockets fired by Hezbollah into Israel on Wednesday, while Lebanese security sources said an Israeli strike hit a car near Beirut, testing a US-mediated deal that aims to get the sides to curb attacks.
At least 21 people, including 18 foreign nationals, were killed in a fire at a hotel in Delhi on Wednesday, police and broadcaster CNN-News18 said, in one of the worst such incidents in the national capital since 2022.