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FDA approves Pfizer-BioNTech's COVID-19 vaccine.


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The U.S. gave full approval to Pfizer-BioNTech's COVID-19 vaccine, a milestone that may help lift public confidence in the shots as the nation battles the most contagious coronavirus variant yet.

The vaccine made by Pfizer and its German partner, BioNTech, now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot's safety.

 

https://www.cbc.ca/news/health/us-pfizer-fda-approval-1.6149959

 

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40 minutes ago, CITIZEN_2015 said:

The U.S. gave full approval to Pfizer-BioNTech's COVID-19 vaccine, a milestone that may help lift public confidence in the shots as the nation battles the most contagious coronavirus variant yet.

The vaccine made by Pfizer and its German partner, BioNTech, now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot's safety.

 

https://www.cbc.ca/news/health/us-pfizer-fda-approval-1.6149959

 

A great milestone in helping people make an informed decision. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

"Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. "

Side effects-  "The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death."

Risks- "Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support."

Long term effects- "Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks."

Overall an achievement for the Pfizer and those that were waiting for FDA approval. 

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My personal favorite anti-vaxxer and conspiracy theorist has a compelling argument on why this news the FDA has approved Pfizer shouldn't make you more confident in the efficacy of the Pfizer vaccine.

One point is her claim Big Pharma provides 75% of the FDA's drug review budget. She also draws parallels between Pfizer and a killer drug named Rezulin. It's a good story if nothing else.

 

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