FDA authorizes Moderna vaccine
WASHINGTON — The U.S. added a second COVID-19 vaccine to its arsenal Friday, boosting efforts to beat back an outbreak so dire that the nation is regularly recording morethan 3,000 deaths a day.
Much-needed doses of the shot are set to arrive Monday after the Food and Drug Administration on Friday authorized an emergency rollout of the vaccine developed by Moderna Inc. and the National Institutes of Health.
The move marks the world’s first authorization for Moderna’s shots. The vaccine is very similar to one from Pfizer Inc. and Germany’s BioNTech that’s now being dispensed to millions of health care workersand nursing home residents as the biggest vaccination drive in U.S.history starts to ramp up.
The two vaccines work “better than we almost dared to hope,” NIH Director Dr. Francis Collins said. “Science is working here. Science hasdone something amazing.”
Early results of large, still unfinished studies show both vaccines appear safe and strongly protective, although Moderna’s is easier to handle since it doesn’t need to be stored at ultra-frozen temperatures like Pfizer’s.
A second vaccine represents another ray of hope amid despair as the virus continues to spread unabated, even before holiday gatherings that are certain to further fuel the outbreak.
The scourge has claimed more than 312,000 American lives and killed 1.7 million people worldwide. New cases in the U.S. are
running at over 216,000 per day on average. Deaths per day have hit all-time highs, eclipsing 3,600 on Wednesday.
California has emerged as one of the most lethal hot spots, with hospitals running out of intensive care beds and ambulances lining up outside emergency rooms in scenes reminiscent of the calamity around New York City in the spring. California on Friday reported over 41,000 new cases and 300 more deaths.
When New York’s hospitals were in crisis, health care workers from across the country came to help out. This time, “there’s no cavalry coming” because so many hospitals are swamped, said Dr. Marc Futernick, an emergency room physician in Los Angeles.
The nation is scrambling to expand vaccinations as rapidly as Moderna and Pfizer can churn out doses. Moderna’s is for people 18 and older, Pfizer’s starts at age 16.
It’s just the beginning of “what we hope will be a big push to get this terrible virus behind us, although it will take many more months to get to all Americans,” Dr. Collins said.
Moderna expects to have between 100 million and 125 million doses available globally in the first three months of 2021, with 85 million to 100 million of those available in the U.S.
Even with additional candidates in the pipeline, there won’t be enough for the general population until spring, and shots will be rationed in the meantime. And while health workers are enthusiastically embracing vaccination, authorities worry the public may need more reassurance to ensure more people get in line when it’s their turn.
“Frankly, if we don’t succeed in getting 80% or so of Americans immunized against COVID-19 by the middle of [2021], we have the risk that this epidemic could go on and on and on,” Dr. Collins said.
He and other public health experts are especially concerned that accurate information about the shots’ value reaches communities of color, which have been hard-hit by COVID-19yet also are wary after years of health care disparities and research abuses.
To try to help instill confidence, Vice President Mike Pence received the Pfizer-BioNTech shot on live TV Friday, along with Surgeon General Jerome Adams.
The FDA’s decision — the first-ever regulatory clearance for the small Cambridge, Mass., company — could help pave the way for other countries that are considering Moderna’s vaccine.
European regulators could authorize its use as soon as Jan. 6. Britain, Canada and a few other countries already have cleared the PfizerBioNTech shot, with a European Union decision due Monday.
“What we want to always remember is one size does not fit all. We want to have options,” said Dr. Paul Duprex of the University of Pittsburgh.
Moderna has about 5.9 million doses ready for shipment set to begin over the weekend, according to Operation Warp Speed, the federal government’s vaccine development program. Injections of health workers and nursing home residents will continue next week, before other essential workers and vulnerable groups are allowed to get in line.