A panel of experts advising the US Food and Drug Administration (FDA) recommended emergency approval for the Pfizer-BioNTech Covid-19 vaccine.
The FDA’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member, in favour of emergency authorisation for people aged 16 years or older, reported The New York Times.
The agency is expected to authorise the vaccine within days, prioritising health care workers and nursing home residents for receiving the first shots of the vaccine early next year.
The New York Times reported that with this formal blessing, the nation may finally begin to slow the spread of the virus just as infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday.
The FDA is expected to grant an emergency use authorisation on Saturday, according to familiar with the agency’s planning, though they cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.
The Pfizer vaccine has been approved for the public in the UK, Canada, Bahrain and Saudi Arabia.
The US authorization of Pfizer’s vaccine is expected to be followed soon by one for Moderna’s version, which uses similar technology and has also shown promising results in clinical trials.
Operation Warp Speed, the Trump administration’s multi-billion-dollar program to fast-track vaccine development, pre-ordered 100 million doses of Pfizer’s vaccine in July and heavily backed the development and manufacturing of Moderna’s vaccine, reported The New York Times.
However, the US needs to vaccinate close to 70 per cent of the population to achieve herd immunity, and it’s going to take time, even if the vaccine is widely accepted.
“I think the data was pretty compelling that the benefits greatly outweigh the risks. I wish there could have been slightly more enrollment of minorities in the trial. But I think the numbers were sufficient to make a decision,” Dr. James Hildreth, a member of the FDA advisory committee said told CNN.
“We know at least in tens of thousands of people followed for two months, it doesn’t have any serious, adverse events. … I think we know enough now to say that this appears to be our way out of this awful, awful mess,” said Dr Paul Offit, another member of the committee.
Meanwhile, Pfizer’s chairman and CEO said he’s pleased that the FDA’s vaccine advisers have voted to recommend the agency grant emergency use authorization for the company’s coronavirus vaccine in the US.
“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” Pfizer Chairman and CEO Albert Bourla said in a statement to CNN.
Earlier this week, the United Kingdom became the first country in the world to administer the new coronavirus vaccine developed jointly by the American drugmaker Pfizer and Germany’s BioNTech in an inoculation programme watched closely around the world.
After UK, Canada became the second country to approve the Pfizer-BioNTech Covid-19 vaccine for its citizens.