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U.S. FDA advisory panel sets stage for Moderna vaccine authorization By Reuters

© Reuters. FILE PHOTO: A small shopping basket filled with vials labeled “COVID-19 – Coronavirus Vaccine” and a medical sryinge are placed on a Moderna logo

By Manas Mishra and Manojna Maddipatla

(Reuters) – A panel of outside advisers to the U.S. Food and Drug Administration on Thursday endorsed emergency use of Moderna (NASDAQ:) Inc’s coronavirus vaccine, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation.

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 (NYSE:) and German partner BioNTech SE (NASDAQ:), 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 U.S. hospitals and healthcare workers.

The Moderna vaccine is set to begin distribution as soon as the FDA gives the green light. Health and Human Services Secretary Alex Azar told CNBC on Thursday that 5.9 million doses have been allotted for state governors and were ready to ship nationwide.

The vaccines are not a panacea, however, as they will take months to roll out to a nation where the virus is running rampant and public health measures such as social distancing and mask wearing are being rejected by large parts of the population.

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 specialized ultra-cold freezers or vast quantities of dry ice, making it easier to supply rural and remote areas.

U.S. officials have said they expect to have 40 million doses of the Pfizer/BioNTech and Moderna vaccines by the end of the year – enough to inoculate 20 million people. Both vaccines were about 95% effective at preventing illness in pivotal clinical trials with no serious safety issues.

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.

Perhaps even more significant, as hospital intensive care units fill to capacity across the country, there were no cases of severe COVID-19 among those who got the vaccine in the trial versus 30 such cases in the placebo group.

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.

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