The Chief Commissioner of the US Food and Drug Administration (FDA), Stephen Hahn, has stated that the organization is working to approve Moderna’s coronavirus vaccine.
He revealed on Thursday that Moderna has been informed by the FDA that the approval of its Covid-19 vaccine candidate will be fast-tracked, as it works towards the finalization and issuance of emergency use authorization (EUA).
Considering the record number of new cases which is overwhelming US hospitals and healthcare workers, the EUA is expected as early as late Thursday or Friday, providing another ray of hope to the United States, which has lost more than 300,000 lives to COVID-19.
Earlier on Thursday, a panel of outside advisers to the US Food and Drug Administration overwhelmingly endorsed emergency use of Moderna’s coronavirus vaccine, virtually assuring a second option for protecting against COVID-19 for a pandemic-ravaged nation.
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The committee voted 20 to 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 and German partner BioNTech, leading to a EUA a day later.
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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.
Members of the US Congress will be able to get vaccinated with the distribution of the first tranche of vaccine doses, the congressional physician said on Thursday.
An emergency meeting of a US Centres for Disease Control and Prevention advisory panel is expected to follow the FDA’s authorization of Moderna’s vaccine, with its official recommendation of its use for the US public.
What they are saying
In a letter to members of Congress and their staff, Dr Brian Monahan, the Attending Physician of the US Congress, said he had been notified by the White House’s National Security Council that:
- “Congress will be provided with a specific number of COVID-19 vaccine doses to meet long-standing requirements for continuity of government operations.”
The Chief Executive of Meharry Medical College, Dr James Hildreth, who voted to recommend the vaccine for emergency use stated that:
- “To go from having a [genetic] sequence of a virus in January to having two vaccines available in December is a remarkable achievement. I’m not convinced that for all of those age groups, the benefits do actually outweigh the risk. And I would prefer to see it more targeted towards people at high risk of serious and life-threatening COVID disease.”
What you should know
- Unlike Pfizer’s vaccine, which comes with complex distribution challenges due to its need to be shipped and stored at minus 70 degrees Celsius, Moderna’s vaccine does not require specialized ultra-cold freezers or vast quantities of dry ice, making it easier to supply to rural and remote areas.
- US officials have said they expect to have 40 million doses of the Pfizer/BioNTech and Moderna vaccines by the end of the year, which could be enough to inoculate 20 million people.
- Both vaccines were about 95 per cent effective at preventing illness in pivotal clinical trials with no serious safety issues.
- The first wave of doses will be earmarked for healthcare workers who treat COVID-19 patients and vulnerable residents and staff of nursing homes.