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An Instagram post from a Tampa Bay nurse casts doubt on the value of the COVID-19 vaccines. So, you injected the non-FDA-approved experimental agent, but you still have to wear a mask and social distance? the March 30 post asks. Does that imply the jab, the mask and the social distancing don’t work? #sodumb Here, we check the claim that any of the COVID-19 vaccines rely on a non-FDA-approved experimental agent. FDA is the U.S. Food and Drug Administration. The claim’s main flaw is it fails to reflect that the FDA authorized the vaccines after months of clinical testing. Emergency Use Authorization In a public health emergency, there’s a defined process to expedite the use of promising drugs. The rationale is that during a crisis that poses an immediate threat to peoples’ lives, it is unethical to stick with the conventional approval process. The new drugs must be fully tested in clinical trials involving tens of thousands of participants. Drug makers have to submit reports on the outcomes and effects on every participant. The chemistry behind the drug, details of the manufacturing process, and the details of the quality controls in place are also required. The data has to show that the drug is both safe and effective. The FDA issued emergency use authorizations for the Pfizer, Moderna and Johnson and Johnson vaccines. While that falls short of a final approval, Northwestern University professor of medical ethics Seema Shah said that’s a distinction with little difference. An emergency use authorization has a slightly lower bar to cross than full approval, but has come about after a comprehensive review of the data, Shah said. Most of the steps cut out by the FDA have to do more with paperwork than with stringency of review. Drug makers must continue to monitor and report any negative outcomes that follow vaccination. That ongoing process underlies the dispute over how to describe the vaccines. A battle over words While vaccine skeptics often use the term experimental agent when referring to the vaccines, the FDA refers to the drugs as investigational vaccines. The agency’s authorization letters tell drug makers to file periodic safety reports at monthly intervals under an investigational new drug tracking system. The manner in which the words are applied is linked to interpretation, said Ross Upshur, head of the Division of Clinical Public Health at the Dalla Lana School of Public Health in Toronto. Experimental agent emphasizes uncertainty. Investigational links back to the clinical trials that preceded the emergency authorization. The nurse behind the post, Erin Marie Olszewski, has appeared on the conservative networks Fox News and One America News. We emailed her through her website and did not hear back. Our ruling An Instagram post described the COVID-19 vaccine as a non-FDA-approved experimental agent. While the vaccines await full FDA approval, the FDA formally authorized their use after reviewing months of data involving tens of thousands of clinical trial participants. Experts in medical ethics said there’s little difference between the trial results that lead to emergency use authorization and final approval. Evaluation of the vaccines continues and drug makers must file monthly reports on any adverse outcomes. We rate this claim Mostly False.
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