WASHINGTON – A United States panel of experts yesterday voted to recommend emergency approval of Moderna’s Covid-19 vaccine, paving the way for six million doses to start shipping as soon as this weekend.
The Food and Drug Administration (FDA) is now expected to imminently grant an emergency use authorisation (EUA), which will make Moderna’s vaccine the second to be approved in a Western country.
The panel voted 20 in favour, none against, with one abstention.
They had been asked to answer the question: “Based on the totality of scientific evidence available, do the benefits of the Moderna Covid-19 vaccine outweigh its risks for use in individuals 18 years of age and older?”
Epidemiologist Arnold Monto, who chaired the live-streamed discussion, said nothing should be read into the fact that the vote was even more overwhelming than last week’s in favour of the Pfizer-BioNTech vaccine.
“Academics have a way of getting involved in details, and what we have done for the last eight or nine hours was to go over the details,” he said.
The meeting came as the number of deaths from the coronavirus quickly approaches 310,000 in the worst-hit country in the world, which this week began vaccinating healthcare workers and long-term care residents with the Pfizer vaccine.
Both of these frontrunners are based on cutting-edge mRNA (messenger ribonucleic acid) technology, which had never been approved prior to the pandemic, and both are two-dose regimens.
Though the level of protection against Covid-19 for both is around 95% – far greater than experts had thought was possible – there have now been a handful of people around the world who developed significant allergic reactions after receiving the Pfizer vaccine.
The US, which has recorded more than 17 million cases of the virus, will probably become the first country to approve the Moderna vaccine.
The small Massachusetts-based biotech firm teamed up with scientists from the US National Institutes of Health on the product and has received more than US$2.5 billion from the US government for its efforts.
Protection against infection
A clinical trial of 30,400 people found it was 94.1% effective in preventing Covid-19 compared to a placebo, performing slightly better in younger adults compared to the elderly.
Jacqueline Miller, Moderna’s vice-president of infectious diseases development, said yesterday that there was a strong suggestion the vaccine also protected most people against infection, which is important from a public health perspective as it will prevent onward transmission.
An FDA review of all available data found there are “no specific safety concerns identified”.
But yesterday, FDA official Doran Fink said should an EUA be granted, the agency will issue a beefed-up warning label regarding potential allergic reactions.
This comes after two healthcare workers in Alaska had such reactions to the Pfizer vaccine, and one of them was hospitalised. Two health workers in the UK also had allergic reactions. – AFP, December 18, 2020
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