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US FDA advisers endorse Moderna as second COVID-19 vaccine

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By Associated Press
Moderna, Inc. HQ, Dec. 15, 2020, in Cambridge, Mass. The Food and Drug Administration said that its COVID-19 vaccine appears safe and highly effecctive.
Moderna, Inc. HQ, Dec. 15, 2020, in Cambridge, Mass. The Food and Drug Administration said that its COVID-19 vaccine appears safe and highly effecctive.   -   Copyright  AP Photo/Elise Amendola
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A U.S. government advisory panel endorsed a second COVID-19 vaccine Thursday, paving the way for the shot to be added to the national 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 advisers, 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 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; Moderna's is four weeks apart.

The two new vaccines will hopefully help "break the back of the pandemic," said Dr. Arnold Monto of the University of Michigan, who chaired the panel.

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.

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, 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 and there are more vaccines in the pipeline.

Like the first vaccine, Moderna's 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. 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 Pfizer vaccine.

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

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