Moderna COVID-19 vaccine trial data debated at U.S. hearing before expected authorization

A panel of outside advisers to the U.S. Food and Drug Administration is expected to endorse emergency use of Moderna Inc.’s coronavirus vaccine during a meeting on Thursday, as the nation prepares to roll out a second vaccine.

The panel vote on whether the vaccine’s benefits outweigh its risks is likely to come in the late afternoon, with an FDA authorization expected as soon as Friday.

This is the same committee of expert advisers that last week backed the COVID-19 vaccine from Pfizer Inc. and German partner BioNTech SE, clearing the way for the FDA emergency use authorization (EUA) a day later.

That vaccine is being distributed throughout the United States. A massive inoculation program began at U.S. hospitals on Monday.

The Moderna vaccine uses similar messenger RNA technology but with less onerous cold storage requirements than the Pfizer/BioNTech shot, making it a better option for remote and rural areas. Both vaccines were about 95 per cent effective in preventing illness in pivotal clinical trials.

WATCH l Canada’s procurement minister talks to CBC News about Moderna vaccine deployment:

Procurement Minister Anita Anand is asked why the U.S. is slated to receive 20 per cent of its initial order of Moderna vaccines by the end of the month, while Canada is expecting 0.84 per cent of its original order. 1:33

The FDA advisory committee is likely to discuss Moderna’s reports of side effects from its 30,000-person trial, which were more frequent than those reported by Pfizer. These were primarily relatively short-lived reactions to the vaccination rather than serious adverse events.

SVB Leerink analysts said the Moderna vaccine appears less tolerable than the Pfizer/BioNTech shot, but noted that is not a proper comparison across trials and unlikely to stand in the way of an EUA.

The FDA staff did not raise any serious concerns about safety in documents published on Tuesday in preparation for the meeting. It said a link between Bell’s palsy, which causes temporary paralysis of facial muscles, and the vaccine could not be ruled out after some cases were reported in trials of both vaccines.

Pfizer and BioNTech said those cases occurred at the same rate as in the general population.

Moderna is seeking authorization for people aged 18 and older. That could sidestep the lively discussion last week among panel members about whether there was enough data to authorize use of the Pfizer/BioNTech vaccine in adolescents aged 16 and 17. They ultimately voted to back that vaccine for those 16 and older.

U.S. government eager to deploy vaccine

The Massachusetts-based company, which has never produced a vaccine on this scale, is working with multiple partners to produce its vaccine, including Switzerland’s Lonza.

Initial Moderna vaccine supply would likely go to the United States, which has signed deals to secure as many as 200 million doses and is expecting the first 20 million this month. The vaccine is administered in two doses about four weeks apart, a longer interval than Pfizer’s three-week period before the second shot.

The White House is eager to deploy the vaccine, given the toll the virus has exacted on the U.S. There were 3,400 deaths attributable to the coronavirus across the country, the COVID Tracking Project from The Atlantic magazine reported on Wednesday. The death toll since the start of the pandemic in the U.S. recently passed 300,000 Americans.

U.S. Health and Human Services Secretary Alex Azar on Thursday said nearly 6 million doses of Moderna Inc.’s experimental COVID-19 vaccine were poised to ship nationwide as soon as it secures Food and Drug Administration approval.

“We’re ready to start shipping this weekend to them for rollout Monday, Tuesday, Wednesday of next week. We’re ready to go,” Azar said in an interview with CNBC.

The company has also signed supply deals with Canada, the European Union and the U.K. The vaccine is undergoing a “rolling review” by regulators for all three.

READ l FDA briefing document on Moderna’s vaccine:

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 expected approval soon 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.

Unlike the Pfizer vaccine, which is being delivered directly by the company to points of use, the federal government will be responsible for the logistics associated with importing the Moderna shot and distributing the product to the provinces and territories.

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