U.S. expert panel endorses Moderna COVID-19 vaccine, paving way for emergency use approval

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

The committee voted 20-0 with one abstention that the benefits of the vaccine outweigh its risks in people ages 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 Moderna an 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 hospitals and health-care 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.

A volunteer gets a shot of the Moderna vaccine during early trials in Binghamton, N.Y., on July 27. (Hans Pennink/The Associated Press)

The vaccines are not a panacea, however, as they will take months to roll out in the U.S., 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.

Prime Minister Justin Trudeau said this week it is expected Canada will receive 168,000 doses of Moderna’s vaccine before the end of the year, contingent on an approval from Health Canada.

In total, six million Moderna and Pfizer vaccines are expected to be delivered to Canada by the end of March 2021, the government has said.

Moderna vaccine better for remote areas

Unlike Pfizer’s vaccine, which comes with complex distribution challenges due to its need to be shipped and stored at extremely cold temperatures, 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.

Those logistical challenges have caused Canada’s territories to focus procurement efforts away from the Pfizer-BioNTech vaccine. 

Nunavut Chief Public Health Officer Dr. Michael Patterson said the territory’s vaccines would be mostly, if not entirely, from Moderna, while Yukon and the Northwest Territories have said they expect doses of Moderna vaccines to arrive by early 2021.

WATCH | Moderna COVID-19 vaccines coming to Canada would benefit the North:

Moderna could ship up to 168,000 doses of its COVID-19 vaccine before the end of the year once it’s approved by Health Canada, which is believed to be close. The prime minister said Moderna could ship vaccines within 48 hours of approval. 1:56

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 per cent effective at preventing illness in pivotal clinical trials with no serious safety issues.

The first doses are expected to be earmarked for health-care workers who treat COVID-19 patients, as well as staff and vulnerable residents 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.

WATCH | How mRNA vaccines can help beyond COVID-19:

The ground-breaking technology used to create the Pfizer and Moderna COVID-19 vaccines, mRNA, could also be used to produce vaccines for other diseases including HIV, the flu and even cancer. 5:18



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