Pfizer COVID-19 vaccine.
Authorized by the Food and Drug Administration for emergency use, the vaccine has now received formal FDA approval. What does that mean?
Kelly Goode, Pharm.D., is a professor in the Department of Pharmacotherapy and Outcomes Science at VCU School of Pharmacy and director of the VCU Community Pharmacy Practice Program and VCU Community Pharmacy Practice Residency Program.
An expert on vaccinations, including the COVID-19 vaccines, Goode is a liaison member of the National Vaccine Advisory Committee.
What does FDA approval mean?
FDA approval grants the company permission to market and distribute the vaccine in the United States. The FDA has evaluated information about safety, effectiveness and whether the manufacturing and facility data ensures product quality and consistency.
How does approval differ from emergency use authorization?
For FDA approval, the manufacturer must submit a biological license application. An independent scientific review is conducted, and there must be substantial evidence of safety, effectiveness and whether the manufacturing and facility data will ensure product quality and safety. For approval, the FDA was requiring 6 months of safety monitoring and follow-up after completion of the clinical trial.
FDA approval is indefinite unless new evidence emerges that presents any cause for concern.
The FDA can make a product available to the public during a public health emergency using the Emergency Use Authorization (EUA). The EUA process is based on the best available evidence when evaluating potential risks versus benefits but without waiting for all the evidence that would be needed for FDA approval. EUA’s are only effective through the emergency declaration or public health emergency.
Are vaccines really safe with just emergency use authorization?
Yes. The vaccine development and clinical trial processes for the EUA required the vaccine to meet rigorous scientific standards for safety, effectiveness and manufacturing quality. However, the primary difference is that some of the data from ongoing clinical trials may be used in the EUA approval, as opposed to data from completed trials.
If you know someone who is hesitant to get vaccinated for fear it might not be safe unless it's FDA approved, how would you talk to that person now that the Pfizer vaccine has full approval?
Full approval is exciting news for the Pfizer-BioNTech COVID-19 vaccine. A comprehensive assessment of post-authorization safety data was conducted, including risks versus benefits, to guide the approval.
Originally Posted by VitaMan
This is NOT worthless. THIS is VitaMan's clarification
that YOU asked for. THIS is part of the reason
for his OPINION!
... YOU there, Oeb - post your shit, mostly opinion
pieces ALL DAY! This bloke here posts one - and YOU
piss on it and call it "worthless"...
... We Australians got a good saying:
"Arithmetic is NOT Opinion!"
... We are ALSO looking for OPINIONS from people here.
NOT just articles, or silly charts and graphics.
Hmmm... and just how much "worthe" does YOUR opinion have?
just sayin'
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