FDA authorizes Moderna COVID-19 vaccine

The U.S. added a second COVID-19 vaccine to its arsenal Friday as the outbreak passes through its most lethal phase yet, with the nation regularly recording over 3,000 deaths per day.The Food and Drug Administration authorized a shot developed by Moderna Inc. and the National Institutes of Health, clearing the way for its use to begin as early as Monday.The move marks the world’s first authorization for Moderna’s shots.“With the availability of two vaccines now for the prevention of COVID-19, 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,” FDA Commissioner Stephen M. Hahn said in a statement.The move gives the U.S. a critical new weapon against the coronavirus in addition to the Pfizer-BioNTech vaccine now being dispensed to millions of health care workers and nursing home patients as part of the biggest vaccination drive in American history.File video: New data shows Moderna’s COVID-19 vaccine is safe, effectiveLarge but unfinished studies show that both vaccines appear safe and strongly protective, though Moderna’s is easier to handle, since it does not need to be kept at ultra-frozen temperatures. Both require two doses for full protection.A second vaccine represents a ray of hope amid despair as the virus continues to spread unabated even before holiday gatherings that are certain to fuel the outbreak.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 authorization puts nearly 6 million doses of Moderna’s vaccine into the pipeline for delivery to hospitals and other facilities across the country. Shipments are expected to begin over the weekend.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,” NIH Director Dr. Francis Collins said.”Authorization of Moderna’s vaccine means we can accelerate the vaccination of frontline healthcare workers and Americans in long-term-care facilities, and, ultimately, bring a faster end to this pandemic,” Health and Human Services Secretary Alex Azar said in a statement Friday.Moderna expects to have between 100 million and 125 million doses available globally in the first three months of 2021, with 85-100 million of those available in the U.S.”Today’s emergency use authorization by the Food & Drug Administration of the Moderna COVID-19 vaccine is another milestone in our battle to overcome the crisis our country is facing today,” President-elect Joe Biden said in a statement Friday while also noting the Pfizer-BioNTech vaccine. “I look forward to receiving the vaccine publicly on Monday and continuing to build confidence in the scientific process.”Even with Moderna’s doses added to the U.S. supply, however, there won’t be enough vaccine for the general population until spring, and shots will be rationed in the meantime. 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. To help instill public confidence in the shot, Vice President Mike Pence received the Pfizer-BioNTech vaccination on live TV Friday, along with Surgeon General Jerome Adams.“Frankly if we don’t succeed in getting 80% or so of Americans immunized against COVID-19 by the middle of this 2021 year, we have the risk that this epidemic could go on and on and on,” Collins said.He is especially concerned that accurate information about the shots’ value reaches communities of color, which have been hard-hit by COVID-19 yet also are wary after years of health care disparities and research abuses.FDA’s decision could help pave the way for other countries that are considering the Moderna vaccine, the first-ever regulatory clearance for the small Cambridge, Massachusetts, company. European regulators could authorize its use as soon as Jan. 6. Britain, Canada and a few other countries already have cleared the Pfizer-BioNTech shot, with a European Union decision due Monday.Both Moderna’s and Pfizer-BioNTech’s shots are so-called mRNA vaccines, made with a groundbreaking new technology. They don’t contain any coronavirus – meaning they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the surface of the virus, ready to attack if the real thing comes along.Their development less than a year after the coronavirus first emerged set a speed record, but Collins stressed that shouldn’t worry people. The speed was due to billions in company and government investments paired with years of earlier scientific research, not any cut corners.“The rigor of the analysis of these vaccines is unprecedented,” Collins said. “We’re not done with this but hope is on the way, and the hope comes from this scientific brain trust that has pulled out all the stops.”