The US food and drug safety regulator can grant emergency authorisation for Pfizer-BioNTech’s Covid-19 vaccine within hours or days now after its advisors voted on Thursday to recommend it use for people over the age of 16, sending a sliver of hope through a country hit the hardest by the pandemic.
The Food and Drug Administration’s vaccine advisory board voted after a day-long meeting that was streamed live to address concerns and scepticism about this vaccine and inoculation generally.
“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risks for use in individuals 16 years of age and older?” was the question put before the board for a vote.
Seventeen members voted yes, four voted against and one abstained.
The advisory team will take a similar vote on pharmaceutical company Moderna’s vaccine next week.
Pfizer has said its vaccines, which have to be stored and transported at extremely low temperatures, will be ready to ship from storage facilities with 24 hours of getting the formal approval.
They will be administered first to those at the highest risk: frontline healthcare workers and residents of nursing homes, and the elderly, who have borne the brunt of the deadly virus.
The Pfizer-BioNTech vaccine has been approved already for use by the United Kingdom, which started administrating it Tuesday — with a man called William Shakespeare among the first recipients, and Canada.
The US will be the third, but probably the most relieved given the scale of the devastation.
The United States accounts for 15.5 million of the 69 million infections worldwide and more than 291,000 of the 1.5 million fatalities. With the onset of winter, it is experiencing a new surge in cases and deaths as people spend more time indoors.
Over 221,000 new cases and 3,000 deaths were reported in the last 24 hours.
Robert Redfield, director of the US Centers for Disease Control and Prevention, has warned it will get worse: more people will die every day of Covid-19 than the toll of the 9/11 terrorist attacks in 2001 — a 9/11 every day, is how commentators are reporting his warning — for the next two or three months.
President-elect Joe Biden welcomed the FDA development as “a bright light in a needlessly dark time” but pointed to the challenges ahead. “Vaccines don’t equal vaccinations,” he said.
“Our challenge now is to scale up manufacturing and distribution to distribute 100 million shots in the first 100 days of my administration.”
There had been no word from President Donald Trump on the development. From the string of his tweets, he appeared more focused on his efforts to overturn his election defeat and rallying Republican elected officials behind around his efforts, that include a long shot lawsuit in the Supreme Court.
