The United States Food and Drug Administration (FDA) issued an emergency authorisation to use the Pfizer-BioNTech COVID-19 vaccine on Friday, paving the way for the first Americans to be immunised in the coming days.
“I am authorising the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19,” Denise Hinton, the agency’s chief scientist wrote in a letter to a Pfizer executive.
The decision follows a regulatory process that involved a panel of independent advisors weighing in on the safety of a two-dose vaccine that the drugmaker had asked to be approved for use in people aged 16 and older.
Officials and medical experts hope the vaccine will help get the pandemic under control after more than 292,000 Americans have been killed to date – more than any other country in the world. More than 15.8 million have been infected.
In a televised statement posted on social media, US President Donald Trump hailed the development as a “medical miracle”, adding that the first vaccine will be administered in the next 24 hours.
“This is one of the greatest scientific accomplishments in history,” he said.
“It will save millions of lives and end the pandemic once and for all.”
More than 2,700 people died in the US on Thursday, according to a tally by Johns Hopkins University – a grim pace that medical officials have said is likely to continue through the coming months.
The worrying surge of COVID-19 cases around the country has filled hospitals and overstretched healthcare workers, many of whom have tested positive for the virus themselves.
In a statement issued on Friday, the FDA said it had notified the US Centers for Disease Control and Prevention (CDC) and Operation Warp Speed – the federal government’s vaccine development programme – to prepare for swift distribution of the vaccine.
Earlier on Friday, Health and Human Services Secretary Alex Azar told ABC’s Good Morning America news programme that following the FDA’s authorisation, “We could be seeing people getting vaccinated Monday, Tuesday of next week”.