What’s the news: The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the SARS-CoV-2 vaccine developed by Moderna Inc. for use in people 18 or older. The vaccine joins Pfizer-BioNTech’s vaccine, which earned FDA authorization last week.
Both vaccines use the messenger RNA technology, consist of two separate doses per patient, and have shown about 95% efficacy in protecting against COVID-19, compared with placebo, in clinical trials involving tens of thousands of participants.
Moderna has said it plans to ship 20 million U.S. doses in December, another 80 million by March 2021, and an additional 100 million by June 2021.
Pfizer’s vaccine, authorized for use in people 16 or older, must be stored at nearly 100 degrees below zero in special freezers. By contrast, regular freezers are cold enough for the Moderna vaccine, which can be refrigerated for up to a month after being thawed. Both companies are moving ahead with studies of their vaccines’ safety and efficacy among children and teenagers.
AMA President Susan R. Bailey, MD, called the authorization “another major step toward vaccinating millions of people across the country.”
“With a second vaccine soon hitting the market, we are on our way to gradually reducing the incidence of death and severe illness from COVID-19,” Dr. Bailey said. “The AMA applauds the FDA and its Vaccines and Related Biological Products Advisory Committee as well as the CDC and its Advisory Committee on Immunization Practices (ACIP) for continued transparency in the process for both authorization and recommended use of COVID-19 vaccines.”
Dr. Bailey, an allergist and immunologist in Fort Worth, Texas, added that the AMA will continue to monitor and urge transparency during the development, authorization and allocation of COVID-19 vaccines.
“Thorough review and transparency are critical to ensuring people in the U.S. are ready and willing to take the vaccine,” she said. “The AMA will also work to ensure physicians are aware of ACIP recommendations for use of all authorized COVID-19 vaccines, as well as their recommendations for prioritizing allocation of the vaccine.”
Learn more about the FDA’s emergency use authorization process for COVID-19 vaccines.
Why it matters: With winter temperatures driving social gatherings indoors, the number of COVID-19 cases in the U.S. has skyrocketed in terrifying fashion. And each day seems to set a tragic new record high for deaths from the highly contagious respiratory illness caused by SARS-CoV-2, often called the novel coronavirus.
The crush of cases is straining hospitals and health systems nearly everywhere around the country, and many intensive care units already have patients occupying every properly staffed bed. Hospitals are canceling admissions and nonemergency procedures, looking for ways to add staff and sending patients to other hospitals many miles away.
While the first vaccine doses are going to those in health care and in long-term residential facilities, there are steps that your patients should be taking now, such as wearing masks around anyone you don’t live with. Find out how to clear up your patients’ confusion about which masks work best.
Learn more: The AMA has developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions, and another to address physicians’ COVID-19 vaccine questions.
In an open letter, the AMA, American Hospital Association and American Nurses Association said physicians, nurses and other health professionals will play a key part in promoting COVID-19 vaccination.
“As front-line caregivers, our essential role in protecting the health and well-being of our communities goes beyond the care we provide. As a valued and trusted voice, our example is perhaps the strongest health resource we have,” says the organizations’ letter. “Our hope is simple; we urge you to get the COVID-19 vaccine and share your experience with others.”
Find out more with the AMA about COVID-19 and vaccine development.
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