2nd COVID-19 vaccine by Moderna set for FDA approval in US after panel endorsement
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 for the vaccine from Moderna and the National Institutes of Health. The FDA advisers, in a 20-0 vote, agreed the benefits of the vaccine outweighed the risks for those 18 years old and up.
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 campaign kicked off earlier this week with the first vaccine OK'd 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 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.
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 in virus totals, with more than 1.6 million confirmed cases and nearly 309,000 reported deaths.
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.
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.
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.
Hundreds of millions of additional shots will be needed to eventually vaccinate the general public, which isn’t expected until the spring or summer. The government’s Operation Warp Speed program has orders for 200 million doses of Moderna’s vaccine. That’s on top of 100 million doses of the Pfizer-BioNTech vaccine. Officials are negotiating to purchase more doses of that vaccine.
Like the first vaccine, Moderna’s vaccine will remain experimental as the company continues a two-year 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 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 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.