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FDA Panel Recommends Moderna Vaccine for Emergency Use Authorization

© AFP 2023 / JOEL SAGETThis file photo taken on November 18, 2020 shows a syringe and a bottle reading "Vaccine Covid-19" next to the Moderna biotech company logo.
This file photo taken on November 18, 2020 shows a syringe and a bottle reading Vaccine Covid-19 next to the Moderna biotech company logo.  - Sputnik International
Medical staffers began administering the first dosages of the Pfizer-BioNTech vaccine on Monday. With a US Food and Drug Administration emergency use authorization, a Moderna vaccine could soon become the second approved for use across the country.

The Vaccines and Related Biological Products Advisory Committee of the FDA voted 20-0 in favor of recommending emergency authorization of a Moderna COVID-19 vaccine for those 18 years or older.  

Michael Kurilla, the director of clinical innovation at the National Center for Advancing Translational Sciences, was the only abstention.

Kurilla explained that he was not confident enough to cast a yes vote because, he detailed, he thought the wording of the emergency use authorization was "too broad."  

“A blanket statement for individuals 18 years and older is far too broad,” he said, reported by STAT. 

By approving a Moderna vaccine, the board is communicating that the benefits of the vaccine outweigh the risks for those age 18 or older. 

"I would prefer to see it more targeted towards people at high risk of serious and life threatening COVID disease,” Kurilla added. 

If the FDA's track mirrors that of the Pfizer-BioNTech vaccine, then a Moderna vaccine could obtain official FDA emergency authorization by Friday. 

US health officials believe that some 20 million Americans would be able to receive their first dose of the Moderna or Pfizer-BioNTech vaccine by the year's end, according to The Hill

Both vaccines, which require two rounds of injections, use messenger RNA to inform the body's cells to create copies of the SARS-CoV-2 virus exterior spike protein. The body then uses these copies as learning tools to begin to detect and attack the virus.

Per a $1.5 billion deal with Moderna, the US is slated to receive some 20 million doses of its vaccine this month and 100 million in the fourth quarter. 

As for the already-approved vaccine, at least four state governors, including Democratic Washington Governor Jay Inslee, have expressed that they have been given conflicting data on the Pfizer-BioNTech vaccine shipments and rollouts. 

Inslee tweeted on Thursday that the US Centers for Disease Control and Prevention informed the state "that WA’s vaccine allocation will be cut by 40 percent next week — and that all states are seeing similar cuts." 

He claims no explanation was provided. 

However, federal officials from the Department of Health and Human Services (HHS) - which contains the CDC - have stated that nothing has changed. 

“Reports that jurisdictions’ allocations are being reduced are incorrect,” an HHS spokesperson said in a statement provided to NBC. “As was done with the initial shipments of Pfizer vaccine, jurisdictions will receive vaccine at different sites over several days.”

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