The FDA Simply Permitted Moderna’s COVID-19 Vaccine: Here is What You Must 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 people ages 18 and older. This makes Moderna the second vaccine to gain FDA approval, following the Pfizer/BioNTech vaccine in August 2021. The US joins countries like Japan, Canada, the UK and Israel, where Moderna has also received official approval.

These vaccines are exactly the same and the names may be used interchangeably. While the Moderna vaccine is already available under emergency use authorization since December 2020 – which simply means it can be used in a declared emergency – this broader authorization may be a huge vote of confidence for those who have not yet been vaccinated. « FDA’s approval of Spikevax is an important step in addressing the COVID-19 pandemic, » FDA Acting Commissioner Janet Woodcock, MD, said in a statement. declaration. « The public can be assured that Spikevax meets the FDA’s high standards for safety, efficacy, and manufacturing quality required for any vaccine approved for use in the United States. »

While the Pfizer vaccine recently received FDA approval for children ages 5 to 11, Spikevax is not yet licensed for those under 18. Like the Pfizer vaccine, Spikevax requires two doses. However, a third dose has also been authorized for immunocompromised people aged 18 and over, as well as a booster for those who have completed their first round 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 came after a series of meticulous tests. In an ongoing randomized clinical trial (prior to the emergence of the omicron variant), 14,287 vaccine recipients and 14,164 placebo recipients Situs Slot Gacor Hari Ini were analyzed. Not all recipients had COVID-19 before receiving their first dose. The trial found Spikevax to be 93% effective in preventing COVID-19. Only 55 cases of COVID-19 were detected in the group that was vaccinated, while 744 cases of COVID-19 were detected in the group that received a placebo. Spikevax has also been shown to be not only highly effective in preventing COVID-19, but 98% effective in preventing serious illness from the virus.

As has been reported with the Pfizer vaccine (and as is the case with just about any medical treatment), Spikevax can cause side effects. The most common side effects include chills, fatigue, nausea, vomiting, swollen lymph nodes, fever, headache, muscle or joint pain, as well as pain, redness and swelling at the vaccine injection site. Based on the FDA’s comprehensive evaluation models, the benefits of Spikevax outweigh the risks, with benefits being fewer symptomatic cases, hospitalizations, ICU admissions, and deaths from COVID-19 .

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