Many Americans are wondering how trustworthy a coronavirus vaccine will actually be.
To help combat the concerns over the safety of a vaccine, the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, have made a pledge and outlined a commitment to "uphold the integrity of the scientific process as they work towards potential regulatory filings and approvals of the first COVID-19 vaccines."
"We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles," Pfizer posted on its website. "The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidelines for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high-quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations."
The FDA, following the pledge from the vaccine companies, wanted to clarify safety standards for a vaccine candidate. However, according to reports, the White House blocked strict new federal guidelines for the emergency release of a coronavirus vaccine candidate. The guidelines would have guaranteed that there would not be a vaccine released ahead of the Nov. 3 election.
On Tuesday, the FDA released the safety standards on its website which stated that vaccine makers should follow trial participants for at least two months to properly rule out safety issues before seeking emergency authorization of their candidate.
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