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Although there are continuing questions about safety, many people are still skeptical about whether the COVID-19 vaccine can be commercialized now, and many people have expressed that they may not be willing to accept this vaccine. However, the FDA still announced that it had granted an Emergency Use Authorization (USA) to Pfizer-Biotech’s COVID-19 vaccine and explained why.
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The FDA has determined that Pfizer’s COVID-vaccine meets “legal standards for US emission.” The agency evaluated the vaccine data and found “clear evidence” that it can effectively protect the public from the new coronavirus.
Similarly, the agency also stated that there is also evidence that the potential benefits of vaccination outweigh the potential risks. “You can assure the public and the medical community that you have already reviewed existing information on safety, efficacy and manufacturing quality. A comprehensive evaluation “.
Simply put, Pfizer’s product is an mRNA vaccine that can teach the body’s immune system to resist the SARS-CoV-2 virus. The FDA noted that it did not approve the vaccine, but only granted emergency use authorization, which is what the FDA can do in emergency situations like a pandemic.
The FDA explained the authorization process and currently known issues:
In deciding whether to issue an EUA for a product, the FDA will evaluate the existing evidence and evaluate any known or potential risks, and any known or potential benefits. If the benefit risk assessment is favorable, the product will be provided in an emergency. Once the manufacturer submits a US application for the COVID-19 vaccine to the FDA, the agency will evaluate the application and determine if it meets the relevant legal standards, considering all the scientific evidence that the FDA has on the vaccine.
Pfizer’s vaccine safety data shows that multiple possible side effects “generally last a few days,” including pain where the vaccine is injected, as well as headache, fatigue, chills, muscle pain, fever, and joint pain. Side effects are more common after receiving the second dose of vaccine.
The full announcement from the US Food and Drug Administration, including safety data and testing details, can be found here:
https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19
