Moderna vaccine wins approval from FDA advisers; emergency use authorization to come quickly
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.
In other developments:
- It’s a hurry up and wait moment on Capitol Hill as congressional negotiators on a must-pass, almost $1 trillion COVID-19 economic relief package struggled through a handful of remaining snags on Thursday. The holdups mean a weekend session now appears virtually certain, along with a stopgap spending bill needed to avert a partial government shutdown at midnight Friday.
- A federal prisoner scheduled to be executed just days before President-elect Joe Biden takes office has tested positive for coronavirus, his lawyer said Thursday.
- The doctor who led development of the first COVID-19 vaccine authorized in the United States and elsewhere said her company’s decision to shift from cancer research to battling the coronavirus happened over breakfast 11 months ago.
- An overwhelming amount of false information about COVID-19 followed the coronavirus as it circled the globe over the past year. And with the U.S., U.K. and Canada rolling out vaccinations this month, many falsehoods are seeing a resurgence online.
- The first doses of the coronavirus vaccine are arriving at Native American communities that have been disproportionately sickened and killed by the pandemic.
- Wearing a white medical mask, French President Emmanuel Macron went ahead with a planned speech by videoconference Thursday, hours after testing positive for COVID-19 following a week in which he met with numerous European leaders.
