US FDA advisory panel endorses Moderna coronavirus vaccine

WION Web Team
Washington, DC, United States of America Published: Dec 18, 2020, 08:19 AM(IST)

Representative image Photograph:( Reuters )

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In the US, where 3,249 new deaths were recorded in the last 24 hours alone, emergency approval of the Moderna jab -- the second vaccine allowed in a Western country -- would pave the way for six million doses to potentially start shipping as soon as this weekend.

A panel of outside advisors to the US Food and Drug Administration (FDA) has overwhelmingly endorsed emergency use of Moderna Inc's coronavirus vaccine.

In the US, where 3,249 new deaths were recorded in the last 24 hours alone, emergency approval of the Moderna jab -- the second vaccine allowed in a Western country -- would pave the way for six million doses to potentially start shipping as soon as this weekend.

The US began rolling out the Pfizer jabs on Monday, hoping to have 20 million people immunised in December.

The committee voted 20-0 with one abstention that the benefits of the vaccine outweigh its risks in people aged 18 and older, one week after the same panel backed a similar vaccine from Pfizer Inc and German partner BioNTech SE, leading to an FDA emergency use authorization (EUA) a day later.

The FDA is expected to grant the EUA as early as late Thursday or Friday, providing another ray of hope to a nation that has lost more than 300,000 lives to COVID-19 - including a one-day high of 3,580 deaths on Wednesday - while record numbers of patients threaten to overwhelm US hospitals and healthcare workers.

The one abstention came from Dr Michael Kurilla, who works at the National Institutes of Health and felt blanket authorization for those 18 and older was too broad.

The Moderna vaccine is set to begin distribution as soon as the FDA gives the green light. 

Unlike Pfizer's vaccine, which comes with complex distribution challenges due to its need to be shipped and stored at -70 Celsius (-94 F), Moderna's vaccine does not require specialised ultra-cold freezers or vast quantities of dry ice, making it easier to supply rural and remote areas.

The company said on Thursday it has expanded the handling guidance for the vaccine to allow it to be moved locally in a liquid state at standard refrigerated temperatures. In some cases, Moderna said, this could be the only practical way to move it to clinics or remote locations.

The first wave of doses are expected to be earmarked for healthcare workers who treat COVID-19 patients and vulnerable residents and staff of nursing homes.

Documents prepared by FDA scientists and released ahead of the meeting, said a two-dose regimen of the Moderna vaccine was highly effective in preventing COVID-19 and did not raise any specific safety issues.

The vaccine, based on the new technology of synthetic messenger RNA (mRNA), is administered in two shots about 28 days apart. The Pfizer/BioNTech shot is also an mRNA vaccine.

About 20 million doses are expected to be delivered this month, with the rest of the initial purchase coming in the first quarter of next year.

The United States in August entered a $1.5 billion pact with Moderna to acquire 100 million doses of its vaccine.

(with inputs)

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