Pfizer applies to US FDA for EUA of its COVID-19 vaccine
The US FDA said that it would hold a meeting of the advisory committee on December 10 at which members would discuss the vaccine
Pfizer has applied to the US FDA for emergency use authorization (EUA) of its COVID-19 vaccine.
The application to the US regulators comes just days after Pfizer and German partner BioNTech reported final trial results that showed the vaccine was 95 per cent effective in preventing COVID-19 with no major safety concerns.
Albert Bourla, CEO, Pfizer confirmed the application had been made in a video posted on the company’s website.
The US FDA said that it would hold a meeting of the advisory committee on December 10 at which members would discuss the vaccine. The agency declined to predict how long its review would take, although both Pfizer and US Health Secretary Alex Azar have said the FDA could authorise the vaccine in mid-December.
It has been reported that Britain has formally asked its medical regulator, the MHRA, to assess the Pfizer-BioNTech COVID-19 vaccine for its suitability.
Britain’s health minister, Matt Hancock, said the government had taken the step after the two companies applied for EUA in the US.
“That has given us the confidence … formally to start the process here,” he told a news conference.
“This is another important step forward in tackling this pandemic. If a vaccine is approved it will, of course, be available across the UK from our NHS (National Health Service), free at the point of delivery, according to need, not ability to pay,” he said.