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| Science & Technology |
| FDA approves Pfizer-BioNTech COVID-19 Vaccine for 16 and older age group |
| 2021-08-23 |
| Posted by:Bubba Lover of the Faeries8843 |
| #5 From a download dated today: https://www.fda.gov/media/150386/download This product has not been approved or licensed by FDA, but has beenauthorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Obviously these things can be faked or edited rather easily...but that is the .gov Grab your Mortan's, because nearly everyone is taking this as a legally available medicine like what you see on TV, so perhaps that link is uncorroborated as of this time. |
| Posted by: swksvolFF 2021-08-23 18:22 |
| #4 Does that mean they can be sued now? I have wondered how far the immunity extends. Can the FDA be sued? Your doctor? Pharmacist? Anyone know? Lawsuit could be as simple as failure to provide adverse reaction info (the insert in the box is blank if you can believe it) which means failure to secure informed consent. |
| Posted by: Angstrom 2021-08-23 15:45 |
| #3 Stages of Vaccine Development and Testing 1.Laboratory and Animal Studies Exploratory Stage, 2-4 years 2.Pre-Clinical Stage, often lasts 1-2 years Many candidate vaccines never progress beyond this stage because they fail to produce the desired immune response. 3.(Investigational New Drug)IND Application A sponsor, usually a private company, submits an application for an Investigational New Drug (IND) to the U.S. Food and Drug Administration. The sponsor describes the manufacturing and testing processes, summarizes the laboratory reports, and describes the proposed study. An institutional review board, representing an institution where the clinical trial will be conducted, must approve the clinical protocol. The FDA has 30 days to approve the application. sorry to post again, but it looks like a minimum of 3 years and 30 days to get a "vaccine" approved by the "FDA" |
| Posted by: 746 2021-08-23 15:19 |
| #2 Probably not but should companies demand it they are not immune. I see full page adds soon by lawyers. |
| Posted by: Dale 2021-08-23 12:53 |
| #1 Does that mean they can be sued now? |
| Posted by: NN2N1 2021-08-23 12:28 |