Moderna’s vaccine nears FDA approval
In a 20- 0 vote, an advisory panel recommends the second COVID- 19 vaccine for emergency use.
WASHINGTON — A government advisory panel endorsed a second COVID- 19 vaccine Thursday, paving the way for the shot to be added to the U. S. vaccination campaign.
The Food and Drug Administration is expected to follow the recommendation and quickly OK the vaccine from Moderna and the National Institutes of Health. The FDA advisors, in a 20- 0 vote, agreed the benefits of the vaccine outweighed the risks for those 18 years old and up.
Once emergency use authorization is granted, Moderna will begin shipping millions of doses, earmarked for health workers and nursing home residents, to boost the largest vaccination effort in U. S. history.
The campaign kicked off this week with the f irst vaccine approved in the U. S., developed by Pfizer and BioNTech. Moderna’s shot showed similarly strong protection, providing 94% protection against COVID- 19 in the company’s ongoing study of 30,000 people.
After eight hours of discussion over technical details of the company’s study and follow- up plans, nearly all panelists backed making the vaccine available to help f ight 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,” Dr. Hayley Gans of Stanford University Medical Center said.
A second vaccine is urgently needed as coronavirus infections, hospitalizations and deaths climb to new highs ahead of the holidays. The U. S. leads the world with more than 17 million confirmed cases and more than 310,000 deaths.
Moderna’s vaccine uses the same groundbreaking technology as Pfizer- BioNTech’s shot. They use snippets of COVID- 19’ s genetic code to train the immune system to detect and f ight the virus.
Thursday’s review came days after reports of apparent allergic reactions to the Pfizer- BioNTech vaccine in two Alaska health workers. One person had a severe reaction, including shortness of breath. The other had less serious side effects, including lightheadedness.
Although the two vaccines use the same technology, they’re not identical, said Dr. Tal Zaks, Moderna’s chief medical officer. In particular, some of the fats used to coat the 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 f lagged 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.
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 before the second dose of either vaccine or placebo. At that one point, swabs from 14 vaccine recipients and 38 placebo recipients showed evidence of asymptomatic infection, said Moderna’s Dr. Jacqueline Miller.
Moderna is just starting to study its vaccine in children ages 12 to 17. Testing in younger children is expected to start early next year.
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, rather than the ultracold required for the PfizerBioNTech shot.
With the addition of Moderna’s vaccine, government officials project that 20 million Americans will be able to get their first shots by the end of December and 30 million more in January.
Hundreds of millions of additional shots will be needed to eventually vaccinate the general public, which isn’t expected until the spring or summer.
Like the f irst vaccine, Moderna’s vaccine will remain experimental as the company continues a twoyear study needed to answer key questions, including how long protection lasts.
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. Their participation is key 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.
Dr. Steven Goodman, an invited expert from Stanford University, suggested Moderna adopt Pfizer’s approach: gradually vaccinate people in its placebo group based on when they would have normally had access to the vaccine.