The FDA Just Authorized the Moderna COVID-19 Vaccine

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The Moderna COVID-19 vaccine is now the second vaccine to receive emergency use authorization from the Food and Drug Administration (FDA). This vaccine, like the Pfizer/BioNTech vaccine that was authorized last week, relies on mRNA technology. But Moderna’s has one major advantage—and was partially funded by Dolly Parton’s research fund.

Moderna’s vaccine is now FDA authorized to prevent COVID-19 infections for people who are at least 18 years old. The vaccine is administered in two doses, given 28 days apart.

The FDA made its decision based on clinical trial data involving 28,207 participants, half of which received the vaccine and the other half received a placebo. There were 185 cases of COVID-19 in the placebo group but only 11 cases in the vaccine group, which suggests the vaccine is just over 94% effective at preventing symptomatic cases of COVID-19. It’s not clear yet whether or not this vaccine can also prevent COVID-19 cases without symptoms or if it can prevent transmission of the virus from person to person.

The most common side effects of the vaccine, which are nearly identical to those of the Pfizer/BioNTech vaccine, include pain at the injection site, headache, chills, fever, tiredness, joint pain, nausea/vomiting, and swollen lymph nodes in the same arm that received the injection. These side effects are temporary and generally went away after several days. More people experienced these side effects after the second dose of the vaccine than after the first.

This vaccine doesn’t contain the coronavirus. Instead, it contains strands of genetic information, the Centers for Disease Control and Prevention (CDC) explain. The body can use that information as instructions to create its own version of a piece of the spike protein present on the surface of SARS-CoV-2, the virus that causes COVID-19. With that, the body can then initiate an immune response that fights off a potential infection later on.

Both of the currently authorized vaccines in the U.S. use this type of technology, but the Pfizer/BioNTech vaccine needs to be kept at very cold temperatures, which requires specialized equipment. The Moderna vaccine doesn’t need to be kept as cold, so it may be able to be distributed to more places more easily, SELF explained previously.

Early data based on clinical trials involving more than 30,000 people in the U.S. suggested that the Moderna COVID-19 vaccine was about 95% effective at preventing symptomatic COVID-19 infections. Preliminary data posted to the FDA site from a Phase 3 clinical trial also suggests the vaccine may be able to prevent asymptomatic infections and transmission of the virus as well, but those findings are based on small amounts of data.

Health care workers and people living in long-term care facilities (like nursing homes) are slated to get the first doses of the vaccines right now. Next up will be other types of essential workers, those with underlying health conditions that put them at a higher risk for severe COVID-19 complications, and people over the age of 65. Experts predict that by mid-2021 the vaccines will be available to the general public.

Just this week the U.S. hit 300,000 deaths due to COVID-19—and more than one person dies due to the coronavirus every minute in the country, CNN reported. Having two FDA authorized vaccines available will be a major step in reducing the toll of the pandemic as we continue to see cases, hospitalizations, and deaths increase. But things won’t immediately go back to “normal,” which is why we still need to wear masks, stay socially distanced, and wash our hands frequently as the vaccines continue roll out over the next several months.

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Related:

https://www.self.com/story/moderna-covid-19-fda-authorization

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