As millions get vaccinated, FDA battles to make safety oversight system work

Feb 12, 2021 Travel News

As millions get vaccinated, FDA battles to make safety oversight system work

It‘s great for routine tasks, but when it comes to safety oversight, it’s all about size,” said Dr Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins University and former federal vaccine official. “The bigger it is, the faster you get a response. Eventually, the VSD will get a really good answer – probably one of the best answers from anyone because they’re so good at doing it. But in a pandemic, time is not on our side.

So far, few serious problems have been reported through these channels, and no deaths have been conclusively linked to the vaccines. The 30-year initiative, known as the Vaccine Adverse Event Reporting System, or VAERS, is based on self-reported cases by patients and healthcare providers.

Health officials say so far the two vaccines already cleared for use appear to be fairly safe. There have been a few severe allergic reactions, including anaphylaxis, but they are treatable and considered rare. The rate at which anaphylaxis has occurred so far – 4.7 cases per million doses of vaccine from Pfizer and BioNTech, and 2.5 cases per million from Moderna’s vaccine – is consistent with what is happening. passes with other widely used vaccines.

Bruising and bleeding caused by low platelet count have also been reported, but it is not known whether they are vaccine-related or coincidental. A total of 9,000 adverse events were reported, of which 979 were serious and the rest classified as non-serious, according to the latest available report from the CDC.

In interviews, public health experts, including current and former FDA and CDC officials, expressed the need to improve the old “passive” surveillance, which relies on self-reporting. They said funding shortages, turf wars and bureaucratic hurdles had slowed the readiness of BEST, officially called the Biologics Assessment Safety Initiative, to monitor Covid vaccines.