Pfizer COVID-19 vaccine.This is NOT worthless. THIS is VitaMan's clarification
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
the covid vaccine which uses 80 year old methodology. Originally Posted by greenbookjust because mRNA has been studied for decades doesn't mean its been in validated USE. Moreover, the COVID "vaccines" have NOT been properly vetted and studied for short-term/long-term effects. In fact, all critical data of these "vaccines" is actively being suppressed, which tells you all you need to know of the suspect nature behind it.
has been administered 6.88 billion times is experimental Originally Posted by greenbookwhat is an experiment? Something you're trying out.
... We Australians got a good saying:The last thing an Aussie needs to do is lecture a U.S. citizen.
"Arithmetic is NOT Opinion!"
... We are ALSO looking for OPINIONS from people here.
NOT just articles, or silly charts and graphics.
Originally Posted by Salty Again
All diseases cause chromosomal damage, as does smoking, exposure to sunlight and even deep space radiation that penetrates your roof and many other cancer causing substances. Most cancers, not all, are a result of DNA damage that cause cell replication error. Think aging, most aging is the result of cell replication error, it is strongly thought that DNA replication is limited to 38 to 43 times before it becomes unreliable. It eventually happens anyway, but it can and is accelerated by disease, etc. Anyway, most of us have received any number of vaccines in our lifetimes, for measles, rubella, small pox, polio, tetanus, influenza, mumps, hep A and B, staph, shingles, pneumonia, HPV and probably three times more than that aggregate number that I cannot recall, but oh my god, the covid vaccine which uses 80 year old methodology and has been administered 6.88 billion times is experimental??? Fuck my mouth, that is just stupid.And so are you if you cannot wrap your mind around proven science. Originally Posted by greenbookMaybe you could point us toward something. I did a google search on chromosomal damage and COVID 19 and didn't find much. Really just a 1970 paper that linked coronaviruses to chromosomal damage. But I didn't look very hard. I'm not saying it's not true. I'm wondering however if it's significant, and I suspect the answer is no.
Results of the study: COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
Conclusions drawn from the study and clinical implications: The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.