FDA approved Moderna Covid vaccine for emergency use

The Food and Drug Administration has approved Moderna’s coronavirus vaccine for emergency use. The vaccine — the second approved for use in the U.S. behind Pfizer and BioNTech’s — bolsters the U.S. supply of doses. The potentially lifesaving shots are desperately needed to fend off the pandemic that has taken more than 300,000 American lives and overwhelmed hospitals.

The FDA’s emergency use authorization Friday approves the federal government’s plan to distribute roughly 5.9 million doses of Moderna’s vaccine to 64 states, territories and major cities across the nation next week.

In addition to Moderna’s vaccine, the U.S. also plans to send out 2 million doses of Pfizer’s vaccine after 2.9 million doses were cleared for shipment this week, Gen. Gustave Perna, who oversees logistics for the Operation Warp Speed vaccine project, said Monday. Both vaccines require two doses three to four weeks apart. Moderna’s Covid vaccine is its first-ever FDA authorized product.

The FDA's main messages:

—Both the new Moderna vaccine and the Pfizer-BioNTech shot require two doses several weeks apart. The second dose must be from the same company as the first.

—In a study of 30,000 volunteers, the Moderna vaccine was more than 94% effective at preventing symptomatic COVID-19 in people 18 and older. It also strongly protected older adults, who are most vulnerable.

—The inoculated can't throw away their masks as it's not yet clear either vaccine prevents silent, symptomless virus spread. But there was a hint that Moderna's shot might provide some protection against asymptomatic infection.

—The Moderna study uncovered no major safety problems. Like with the Pfizer-BioNTech shot, expect sore arms, fever, fatigue and muscle aches, which are signs the immune system is revving up.

—Both vaccines carry "a remote chance" of causing a severe allergic reaction. Moderna's study turned up none of these, though a handful were reported in Britain as the Pfizer-BioNTech vaccinations got underway and the FDA is looking into five in the U.S., including a severe reaction in Alaska. The vaccines' ingredients aren't identical. Still, after any COVID-19 vaccination, people should stick around for 15 minutes—or 30 minutes if they have a history of severe allergies—so if they do have a reaction, it can be treated immediately.

—Both vaccines remain experimental, and the government is closely monitoring safety in case rare problems crop up.

—Additional studies are needed to tell if the vaccine should be used by pregnant women and children. Women who are pregnant or breastfeeding should discuss whether to get the vaccine with their doctor.

Source:

https://medicalxpress.com/news/2020-12-moderna-vaccine-covid-2nd-shot.html

https://www.cnbc.com/2020/12/18/moderna-covid-vaccine-approved-fda-for-emergency-use.html