BackCovid vaccine: US FDA panel recommends emergency approval of Moderna vaccine
The US Food and Drug Administration is expected to grant the EUA as early as late Thursday or Friday, providing another ray of hope to a nation that has lost over 300,000 people to the killer virus
PremiumA panel of outside advisers to the US drug regulators have overwhelmingly endorsed the emergency use of Moderna Inc's Covid-19 vaccine, virtually assuring a second option for protecting against the deadly virus for a pandemic ravaged country.
The committee voted 20-0 with one abstention that the benefits of the Covid-19 vaccine outweigh its risks in people aged 18 and older, one week after the same panel backed a similar vaccine from American giant Pfizer and its German partner BioNTech SE, leading to an FDA emergency use authorization (EUA) a day later, reports news agency Reuters.
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The US Food and Drug Administration is expected to grant the EUA as early as late Thursday or Friday, providing another ray of hope to a nation that has lost over 300,000 people to the killer virus, including a one-day high of 3,580 fatalities on Wednesday, while record numbers of patients threaten to overwhelm US hospitals and healthcare workers.
"To go from having a (genetic) sequence of a virus in January to having two vaccines available in December is a remarkable achievement," Dr James Hildreth, chief executive of Meharry Medical College, who voted to recommend the Moderna vaccine for emergency use, said.
However, the one abstention came from Dr Michael Kurilla, who works at the National Institutes of Health and felt blanket authorisation for those 18 and older was too broad.
"I'm not convinced that for all of those age groups the benefits do actually outweigh the risk. And I would prefer to see it more targeted towards people at high risk of serious and life-threatening COVID disease," he said.
FDA advisers agree to benefits of Moderna vaccine
Moderna's coronavirus vaccine won backing from a panel of experts who advise the US FDA, setting the stage for its shot to be the second vaccine cleared in America.
Meanwhile, FDA advisers have agreed that the benefits of Moderna's vaccine outweigh any risk, giving a boost to efforts to ramp up the US immunisation campaign.
The effort is initially focusing on health-care workers and seniors who live in long-term care facilities. The FDA could authorise the shot within the next day.
Moderna's product is based on the same technology as a shot made by Pfizer and BioNTech SE that was cleared by the FDA some time back, and like that vaccine showed a high degree of efficacy in late-stage clinical trials.
At the advisory meeting on Thursday, some of the discussion focused on a handful of allergic reactions experienced by people in America and Britain who got the Pfizer dose.
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