A United States government advisory panel has endorsed the Pfizer-BioNTech COVID-19 vaccine, a critical step towards the vaccine’s final approval for eventual distribution across the country.
A panel of outside advisers to the US Food and Drug Administration (FDA) on Thursday evening voted 17-4 in favour of the vaccine, with one abstention, deciding that its benefits outweigh any risks for use by individuals aged 16 years and older.
The FDA is expected to authorise the vaccine’s distribution in the coming days.
That means that millions of doses of the vaccine soon could be distributed across the US, which has the highest number of COVID-19 infections and deaths linked to the novel coronavirus in the world.
“Americans want us to do a scientific review, but I think they also want us to make sure we’re not wasting time on paperwork as opposed to going forward with the decision,” FDA Commissioner Stephen Hahn said before the meeting.
Both the United Kingdom and Canada have already authorised the Pfizer-BioNTech vaccine, with the first doses administered in the UK earlier this week. Canada said the vaccines will be ready to be administered as of next Monday.
The US has recorded more than 15.5 million cases of COVID-19 since the start of the pandemic, according to a Johns Hopkins University tally, and more than 291,000 deaths have been reported.
The country has seen a recent surge of COVID-19 cases as colder weather pushes people indoors, where the virus can more easily spread.
Hospitals have been overwhelmed and local officials in several US states have instituted lockdown measures to stem the spread of infections. Many are hoping that the distribution of an approved vaccine can bring the pandemic under control.
Citing people familiar with the FDA’s planning, The New York Times reported on Thursday that the agency is planning to issue an emergency use authorisation for the Pfizer-BioNTech vaccine on Saturday.
The agency will begin with an initial shipment of 6.4 million doses, the US newspaper reported, citing federal officials, who said these doses would leave warehouses within 24 hours of FDA clearance.
Initial supplies are expected to be reserved for healthcare workers and nursing home residents, with other vulnerable US citizens next in line to receive the shots.