US panel seeks approval of Moderna vaccine

19 December, 2020 12:00 AM printer

WASHINGTON: A US panel of experts on Thursday 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, reports AFP.

The Food and Drug Administration is now expected to imminently grant an emergency use authorization (EUA), which would make Moderna’s vaccine the second to be approved in a Western country. The panel voted 20 in favor, 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 favor 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 health care 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 percent — 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 $2.5 billion from the US government for its efforts.

A clinical trial of 30,400 people found it was 94.1 percent 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 Thursday that there was a strong suggestion the vaccine also protected most people against infection, which is important from a public health perspective as it would prevent onward transmission.


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