Read up -- oh you feckless would-be Tangerine Mussolini:
“. . .The biopharmaceutical industry is confident we can beat COVID-19 because science guides every aspect of our work. Our industry is committed to ensuring the highest of standards of research, clinical testing and manufacturing are upheld throughout the vaccine research and development process.
“As part of this commitment, this morning the leading biopharmaceutical companies working on vaccines for COVID-19 issued a pledge ‘to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.’
“Because vaccines are given to healthy individuals, industry sponsors will be confident in the safety and efficacy of any new vaccine based on data from rigorous, large clinical trials including the expectation that diverse populations are included, before submitting the data to U.S. Food and Drug Administration (FDA) and other national regulatory agencies around the globe for review.
We furthermore believe in a transparent review process of vaccine candidates by the FDA, including by the Agency’s Advisory Committees. . . .
Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
Always make the safety and well-being of vaccinated individuals our top priority.
Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA. . . .
Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.
“Numerous approaches are being undertaken by our industry to research and develop vaccine candidates in collaboration with government agencies, academia and other entities. The decades-long investments biopharmaceutical companies have made in new technologies, research and previous vaccines have prepared our industry to act swiftly, without cutting corners, to respond to the COVID-19 pandemic and we’re confident science will win. . . .”
It is unprecedented, and jaw-slacking that this statement was needed. Disturbing, that we have a Commander in Chief who is so plainly unable, and unwilling to accept basic scientific safety principles when he perceives a potential electoral advantage. . . not to do so. Onward, just the same.
नमस्ते
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