“It’s great for routine activities, but when it comes to security surveillance, size is all,” said Dr. Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University and former federal vaccine officer. “The bigger it is, the faster you get an answer. At some point the VSD is going to get a really good answer – probably one of the best answers out there because they are so good at it. But in a pandemic, time is not on our side. “
Few serious problems have been reported through these channels to date and no deaths have been clearly linked to the vaccines. The 30-year initiative, known as the Vaccine Adverse Event Reporting System (VAERS), relies on self-reported cases from patients and health care providers.
Health officials say the two vaccines already approved for use appear to be reasonably safe so far. There have been some serious allergic reactions, including anaphylaxis, but they are treatable and are considered rare. The rate at which anaphylaxis has occurred to date – 4.7 cases per million doses for the vaccine from Pfizer and BioNTech and 2.5 cases per million for the vaccine from Moderna – is in line with other widely used vaccines.
Bruising and bleeding caused by decreased platelet counts have also been reported, although it is not known whether they are vaccine-related or accidental. A total of 9,000 adverse events were reported, of which 979 were classified as serious and the remainder classified as non-serious according to the latest available CDC report.
In interviews, public health experts, including current and former FDA and CDC officials, expressed the need to improve on the old “passive” surveillance that relies on self-reporting. They said funding shortages, turf wars and bureaucratic hurdles had slowed BEST, officially known as the Biologics Evaluation Safety Initiative, in preparation for monitoring Covid vaccines.
