FDA expert panel endorses Moderna coronavirus vaccine

Coronavirus Vaccine

WASHINGTON (NewsNation Now) — 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 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 and German partner BioNTech SE, leading to an FDA emergency use authorization (EUA) a day later.

The FDA’s green light for emergency use is expected quickly. Moderna would then begin shipping millions of doses, earmarked for health workers and nursing home residents, to boost the largest vaccination effort in U.S. history.

The FDA reviewers said a two-dose regimen of Moderna’s vaccine was highly effective in preventing confirmed cases of COVID-19 and did not raise any specific safety issues with using the vaccine in adults over the age of 18.

After seven hours of debate over technical details of the company’s study and follow-up plans, nearly all panelists backed making the vaccine available to help fight the pandemic. One panel member abstained.

“The evidence that has been studied in great detail on this vaccine highly outweighs any of the issues we’ve seen,” said Dr. Hayley Gans of Stanford University Medical Center.

Moderna’s vaccine uses the same groundbreaking technology as Pfizer-BioNTech’s shot. Most traditional vaccines use dead or weakened virus, but both of the new vaccines use snippets of COVID-19’s genetic code to train the immune system to detect and fight the virus. Both require two doses, several weeks apart.

Moderna’s is the second vaccine the FDA has considered, behind one from Pfizer Inc. and Germany’s BioNTech, which was authorized last week.

While the two vaccines use the same technology, they’re not identical, cautioned Moderna chief medical officer Dr. Tal Zaks. In particular, some of the lipids, or fats, used to coat the two vaccines are different.

“I would not necessarily assume” that any reactions would be the same, he said.

The FDA found no severe allergic reactions in Moderna’s data but flagged a slightly higher rate of less serious side effects — rash, hives, itching — among participants who got the vaccine, compared with those receiving a dummy shot.

There were also three cases of Bell’s palsy, which temporarily paralyzes facial muscles, among vaccine recipients, compared with just one among those getting a dummy shot. The FDA review said the role of the shot in the vaccine group “cannot be ruled out.”

An unanswered question is whether the vaccine also prevents people from symptomless infection – but Moderna found a hint that it may. Study participants had their noses swabbed prior to the second dose of either vaccine or placebo. At that one timepoint, swabs from 14 vaccine recipients and 38 placebo recipients showed evidence of asymptomatic infection, said Moderna’s Dr. Jacqueline Miller.

After the FDA acts, U.S. officials plan to move out an initial shipment of nearly 6 million Moderna doses. The vaccine needs to be stored at regular freezer temperatures, but not the ultra-cold required for Pfizer-BioNTech’s shot.

One of the trickiest issues panelists debated was how to keep study volunteers who received a dummy shot from dropping out to get the real shot once its authorized. Their participation is critical in order to have a comparison for long-term safety and effectiveness.

Moderna proposed immediately alerting all those volunteers of their status and offering them the vaccine. The company said more than 25% of its participants are health workers and some are already leaving to get the first vaccine.

But Dr. Steven Goodman, an invited expert from Stanford University, urged Moderna to adopt Pfizer’s approach. Pfizer plans to gradually vaccinate people in its placebo group based on when they would have normally had access to the vaccine, as priority groups are established.

But most panelists acknowledged it will be hard to keep volunteers from leaving the Moderna study if they have to wait to get the vaccine.

“The reality may make that too difficult to do,” said Dr. Steven Pergam of the Seattle Cancer Care Alliance.

The only COVID-19 death in the 30,000 volunteers was in a placebo recipient, a 54-year-old man whose only risk factor was diabetes.

Knowing there could be more severe coronavirus in placebo recipients as the pandemic continues “weighs heavily on me,” said Moderna’s Miller.

Vice President Mike Pence, his wife Karen and Surgeon General Dr. Jerome Adams are set to publicly receive the Pfizer vaccine Friday. It’s all part of a push to build public confidence in the vaccine. President-elect Joe Biden is scheduled to receive the vaccine next week. There is no confirmation on when President Donald Trump will receive the vaccine.

The full briefing released prior to the meeting can be read below:

The Associated Press and Reuters contributed to this report.

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