As Millions Get Shots, F.D.A. Struggles to Get Safety Monitoring System Running

“This routine is great for stuff, but when it comes to security monitoring, it’s about size,” Dr. Said Daniel Salmon, director of the Institute of Vaccine Safety at Johns Hopkins University and a former federal vaccine officer. “The larger it is, the faster you get the answer. Eventually VSD will get a really good answer – probably one of the best answers to anyone because they are so good at doing it. But in an epidemic, time is not on our side. “

So far, some serious problems have been reported through these channels and none of the deaths have been conclusively linked to vaccines. The 30-year initiative, known as the Vaccine Advance Event Reporting System, or VAERS, relies on self-reported cases from patients and health care providers.

Health officials say that so far, two vaccines already authorized for use appear to be quite safe. There have been some serious allergic reactions including anaphylaxis, but they are treatable and are considered rare. The rate at which anaphylaxis has occurred so far – 4.7 cases per million doses of vaccine by Pfizer and BioNotech, and 2.5 cases per million for the vaccine by Modern – accompanies such widely used vaccines.

Caused by bruising and bleeding Platelet count decreases It has also been reported, although it is not known whether they are associated with vaccines, or by coincidence. According to the most recently available CDC report, with 979 serious and 979 reported adverse events, the rest were classified as nonrenewable.

In interviews, public health experts, including current and former officials at the FDA and CDC, expressed the need to improve on chronic “passive” surveillance, which relies on self-reporting. He said lack of funds, turf wars and bureaucratic hurdles had slowed down the preparation of the BEST, formally Biologics Evaluation Safety Initiative, to monitor Kovid vaccines.

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