US experts on Thursday voted to recommend granting emergency approval for Pfizer-BioNTech’s COVID-19 vaccine, paving the way for the US to become the next country to move ahead with mass immunization.
It comes as the worst-hit country in the world logged nearly 6,000 virus deaths in 48 hours and its overall toll was approaching 300,000.
With northern hemisphere countries hit by a pandemic winter surge, Britain this week became the first Western country to roll out the Pfizer-BioNTech vaccine. Canada, Bahrain and Saudi Arabia have also approved it.
Photo: AFP
EU countries eagerly awaited a greenlight for vaccines that the bloc’s own watchdog said remained on track for approval despite a two-week-long cyberattack, which is under investigation.
Independent experts convened by the US Food and Drug Administration (FDA) voted 17 in favor and four against, with one abstention, for emergency approval of the two-dose regimen in people aged 16 and older.
The vote is nonbinding, but a formal emergency use authorization is expected within days.
Momentum was building as the New England Journal of Medicine published full results of a clinical trial of the vaccine involving nearly 44,000 people, which confirmed it was 95 percent effective with no serious safety issues.
“This is a triumph,” an accompanying editorial said.
Nevertheless, the voting members of the Vaccines and Related Biological Products Advisory Committee mulled outstanding issues closely in a livestreamed event held over the course of the day.
These included difficult questions like when people who received placebos in the trial should receive the vaccine, a tricky debate that weighs the need for more controlled data against paying back altruistic volunteers for their service.
Other questions include whether unexpected safety issues might arise when the number of people vaccinated grows to millions and possibly billions of people.
Also unknown is whether more side effects will emerge with longer follow-up, how long the vaccine remains effective, whether it will limit transmission and how it will work in children, pregnant women and immunocompromised patients.
The FDA said it would issue an allergy warning following Britain’s lead after two healthcare workers there suffered reactions and needed treatment.
The virus has killed at least 1,570,398 people worldwide since the outbreak emerged in China in December last year, according to a tally from official sources.
The US hopes to vaccinate 20 million people this month, with long-term care facility residents and health workers at the front of the line.
US president-elect Joe Biden called the FDA experts’ decision a “bright light in a needlessly dark time.”
He highlighted the challenge in distributing it, calling for funding from the US Congress and for “the Trump Administration to purchase the doses it has negotiated with Pfizer and Moderna and to work swiftly to scale manufacturing for the US population and the world.”
The first vaccine shipments to 14 sites across Canada are scheduled to arrive on Monday with people receiving shots a day or two later, said Canadian Armed Forces Major-General Dany Fortin, the commander coordinating distribution in the country.
Healthcare workers and vulnerable populations including the elderly are to be the first to receive it.
“I’m really excited. I want to get vaccinated as soon as possible, because I have a new baby,” Michelle, a Toronto resident, said.
Development of a COVID-19 vaccine in Australia was abandoned after clinical trials produced a false positive HIV result among subjects involved in early-stage testing.
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