The US Food and Drug Administration has authorised the Pfizer-BioNTech coronavirus vaccine for emergency use.
The agency said the authorisation was a "significant milestone" in the pandemic, which taken more than 295,000 lives in the US.
The vaccine, which offers up to 95% protection against Covid-19, was deemed safe and effective by the FDA.
President Donald Trump said the first vaccinations will take place "in less than 24 hours".
"Today our nation has achieved a medical miracle," Mr Trump said. "We have delivered a safe and effective vaccine in just nine months."