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The FDA Just Approved Moderna’s COVID-19 Vaccine: Here’s What You Should Know

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The U.S. Food and Drug Administration (FDA) announced on Monday that it has approved the Moderna COVID-19 vaccine for individuals aged 18 years and older. This makes Moderna the second vaccine to gain FDA approval, after the Pfizer/BioNTech vaccine in August 2021. The U.S. joins countries such as Japan, Canada, the U.K., and Israel, where Moderna has also received official approval.

These vaccines are exactly the same, and the names can be used interchangeably. While the Moderna vaccine has already been available under emergency use authorization since December 2020—which simply means it can be used during a declared emergency—this wider authorization may come as a huge vote of confidence for those yet to be vaccinated. “The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic,” said acting FDA Commissioner Janet Woodcock, M.D., in a statement. “The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States.”

While the Pfizer vaccine recently received FDA approval for children aged 5 to 11, Spikevax is not yet authorized for individuals under 18. Like the Pfizer vaccine, Spikevax requires two doses. However, a third dose has also been authorized for immunocompromised people aged 18 years and older, and also as a booster shot for those who have completed their initial series of Spikevax or another authorized COVID-19 vaccine. More than 61% of the world’s population has received at least one dose of a COVID-19 vaccine, with 10.1 billion doses having been administered internationally.

The FDA’s decision to approve Spikevax has come after meticulous rounds of testing. In an ongoing randomized clinical trial (before the emergence of the omicron variant), 14,287 vaccine recipients and 14,164 placebo recipients were analyzed. All recipients did not have COVID-19 before receiving their first dose. The trial found that Spikevax was 93% effective in preventing COVID-19. Only 55 cases of COVID-19 were detected in the group who were vaccinated, while 744 COVID-19 cases were detected in the group who received a placebo. Spikevax was also found to not only be highly effective in preventing COVID-19 but 98% effective in preventing severe illness as a result of the virus.

As it has been reported with the Pfizer vaccine (and as is the case with pretty much any medical treatment), Spikevax can lead to some side effects. The most common side effects include chills, fatigue, nausea, vomiting, swollen lymph nodes, fever, headache, muscle or joint pain, and pain, redness, and swelling where the vaccine was injected. Based on the FDA’s comprehensive assessment models, the benefits of Spikevax outweigh the risks, the benefits being fewer symptomatic cases, hospitalizations, intensive care admissions, and deaths as a result of COVID-19.

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