A panel of outside advisers to US drug regulators has overwhelmingly endorsed the emergency use of Moderna Inc.’s Covid-19 vaccine, virtually guaranteeing a second choice to protect against the deadly virus in a country devastated by the pandemic.
The committee voted 20-0 with one abstention that the benefits of the Covid-19 vaccine outweigh its risks in people over 18, a week after the same panel endorsed a similar vaccine from US giant Pfizer and its German partner BioNTech. SE, Leader to FDA Emergency Use Authorization (USA) One Day Later, News Agency Reports Reuters.
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The US Food and Drug Administration is expected to award the EUA on Thursday or Friday night, bringing another ray of hope to a nation that has lost more than 300,000 people to the killer virus, including a maximum a day of 3,580 deaths on Wednesday. while a record number of patients threatens to overwhelm US hospitals and healthcare workers.
“Going from having one (genetic) sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said Dr. James Hildreth, executive director of Meharry Medical College, who voted to recommend the Modern vaccine for use. emergency, he said.
However, the only abstention came from Dr. Michael Kurilla, who works at the National Institutes of Health and felt that the blanket authorization for those over 18 was too broad.
“I’m not convinced that for all of those age groups the benefits really outweigh the risk. And I would rather see it more targeted at people at high risk for serious and life-threatening COVID disease,” he said.
FDA advisers agree on the benefits of the Moderna vaccine
Moderna’s coronavirus vaccine garnered endorsement from a panel of experts advising the US FDA, setting the stage for its injection to be the second approved vaccine in the United States.
Meanwhile, FDA advisers have agreed that the benefits of Moderna’s vaccine outweigh any risks, giving a boost to efforts to accelerate America’s immunization campaign.
The effort initially focuses on healthcare workers and older people living in long-term care facilities. The FDA could authorize the injection the next day.
Moderna’s product is based on the same technology as an injection made by Pfizer and BioNTech SE that was approved by the FDA some time ago, and like that vaccine it showed a high degree of efficacy in late-stage clinical trials.
At Thursday’s counseling meeting, part of the discussion centered on a handful of allergic reactions experienced by people in the United States and Britain who received the Pfizer dose.
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