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https://www.fda.gov/media/144636/downloadBased on the safety and effectiveness data, and review of manufacturing information regarding product quality and consistency, it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Moderna COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 18 years of age and older.
https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-recipients.pdfWHAT IS THE MODERNA COVID-19 VACCINE?
The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.
The FDA has authorized the emergency use of the Moderna COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization (EUA).
https://nature.com/articles/d41586-021-00316-4Close to 90% of people aged 60 and older in the country have received their first dose of Pfizer’s 2-dose vaccine so far. Now, data collected by Israel’s Ministry of Health show that there was a 41% drop in confirmed COVID-19 infections in that age group, and a 31% drop in hospitalizations from mid-January to early February.
Some (most?) people equate that with "generally safe"; I read it as "safe enough".In the case of a vaccine, authorization can be granted if “the known and potential benefits outweigh the known and potential risks,” the FDA says.
One can certainly disagree with the FDA and assert that the vaccines are "generally safe", i.e. safe for general (not just emergency) use. Everyone is entitled to an opinion.• It was 95% effective at preventing cases of COVID-19 in both Latinos and non-Latinos.
• It was 100% effective in Black people.
• It was 94% effective in people who were at least 56 years old. (The older you get, the greater the risk of a serious case of COVID-19.)
• It was 95% effective in those who had at least one medical condition that made them more likely to develop a serious case of COVID-19.
• It was 96% effective for people who were obese, another condition that makes people more vulnerable to COVID-19.
Yet none of this was enough for the vaccine to win official FDA approval.
Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the vaccine or placebo.
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