Can information reported to VAERS cause a recall of a vaccine?
The FDA has the authority to recall a vaccine from use in the United States if they feel it represents a risk to the American public. VAERS reports may signal that there is the potential for a safety risk, which would prompt a wider evaluation of the safety of the vaccine lot. If the evaluation confirms a risk, the batch can be recalled.
The FDA has the authority to recall a vaccine from use in the United States if they feel it represents a risk to the American public. VAERS reports may signal that there is the potential for a safety risk, which would prompt a wider evaluation of the safety of the vaccine lot. If the evaluation confirms a risk, the batch can be recalled. Over the last 10 years, there have been only three vaccine recalls. One batch of vaccine was recalled after the FDA detected impurities in the vaccine; another was mislabeled. The third batch was recalled because an FDA inspection found substandard conditions at the production plant which had the potential to produce a substandard batch. In the winter of 1996-97, a pharmaceutical company voluntarily withdrew a vaccine from distribution because it did not retain its protective effect long enough after manufacture to meet Federal standards. This vaccine was not a safety threat, but did not work well enough to protect people from getting the disease it wa
