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> when the science is not clear about the cost:benefit It is clear > emergency experimental COVID-19 vaccines They're not "experimental" and the emergency
by KennyBlanken 5y ago
> when the science is not clear about the cost:benefit
It is clear
> emergency experimental COVID-19 vaccines
They're not "experimental" and the emergency approval process is still extensive.
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...
> What is the process that manufacturers are following to potentially make a COVID-19 vaccine available by EUA?
> Vaccine manufacturers are undertaking a development process that includes tens of thousands of study participants to generate non-clinical, clinical, and manufacturing information needed by FDA for the agency to determine whether the known and potential benefits outweigh the known and potential risks of a vaccine for the prevention of COVID-19.
> When the phase 3 portion of the human clinical trial reaches a predetermined point that informs how well a vaccine prevents COVID-19, as discussed and agreed to in advance with FDA, an independent group (called a data safety monitoring board) will review the data and inform the manufacturer of the results. Based on the data and the interpretation of the data by this group, manufacturers decide whether and when to submit an EUA request to FDA, taking into consideration input from FDA.
> After FDA receives an EUA request, our career scientists and physicians will evaluate all of the information included in the manufacturer’s submission.
> While FDA’s evaluation is ongoing, we will also schedule a public meeting of our Vaccines and Related Biological Products Advisory Committee, which is made up of external scientific and public health experts from throughout the country. During the meeting, these experts, who are carefully screened for any potential conflicts of interest, will discuss the safety and effectiveness data so that the public and scientific community will have a clear understanding of the data and information that FDA is evaluating to make a decision whether to authorize a COVID-19 vaccine for emergency use.
> Following the advisory committee meeting, FDA’s career professional staff will consider the input of the advisory committee members and continue their evaluation of the submission to determine whether the available safety and effectiveness and manufacturing data support an emergency use authorization of the specific COVID-19 vaccine in the United States.
Hmmmm, who to trust...a so-so actor from a 90's sitcom, or hundreds of scientists