The Food and Drug Administration authorized emergency use of Moderna’s coronavirus vaccine Friday, launching a second option to inoculate against the virus and adding millions of doses to the national supply.
The agency’s green light was widely expected after an expert advisory committee nearly unanimously endorsed the vaccine on Thursday and FDA Commissioner Stephen Hahn said it would “rapidly work” to finalize the authorization. Federal health officials also already promised that they would begin shipping out millions of doses this weekend.
“The FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” Hahn said in a statement Friday announcing the authorization.
The vaccine proved nearly 95 percent effective in clinical trials that enrolled 30,000 patients, roughly 40 percent of whom were over the age or 65 or had chronic medical conditions like heart problems and diabetes that made them more vulnerable to the virus.
The FDA authorization now allows its use for people 18 and over. The first coronavirus vaccine to be authorized in the United States, from Pfizer, is authorized for people as young as 16.
Nearly 6 million doses of Moderna’s vaccine will be shipped out to 3,285 sites across the country in the first week, General Gustave Perna, chief operating officer of Operation Warp Speed, said Monday.
Like the first authorized coronavirus vaccine, from Pfizer, the Moderna shot uses messenger RNA technology that gives cells instruction to recognize and fight the virus. The Trump administration last week doubled its vaccine order from Moderna to 200 million doses after Pfizer said it wouldn’t be able to deliver more vaccine until the third quarter of 2021.
Moderna, a ten-year-old Massachusetts biotechnology company, has never brought a product to market before. But the company developed its potential vaccine within days of learning the virus’ genetic sequence and began working with the National Institutes of Health to put doses into trials. Moderna was the first among dozens of vaccine makers to begin late-stage trials with tens of thousands of volunteers.
It received nearly $1 billion from the U.S. government to develop and study the vaccine.
Moderna in May signed a manufacturing contract with Swiss company Lonza AG to produce up to one billion doses of the vaccine in the next year. In the meantime, it is likely to be a cornerstone of the U.S. goal to immunize millions of Americans.
The administration has spent billions to secure as many as 900 million potential vaccines from six manufacturers. But several have hit snags that could delay authorization and more options against the pandemic.
There are also fresh concerns that people with severe allergies could have a reaction to the Pfizer vaccine. While Moderna did not report allergic reactions in its own trials, it’s not typical that people with severe allergies are enrolled in these types of studies.
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