Information on Shingrix

The FDA is committed to safety and transparency for all Americans using any medicine. As a result of their commitment to safety and transparency, the FDA has decided to include GBS on information about the possible side effects of the Shingrix vaccine for shingles, given to older Americans.

This safety warning ONLY applies to one brand of a shingles vaccines, Shingrix. The decision to include GBS was made after evaluating data in postmarketing studies, in which the FDA noted 3-6 more cases than expected of GBS per 1 million shots. The FDA states that there is no known causal relationship between the Shingrix vaccine and GBS, and that the benefit of Shingrix still outweighs the risks of rare but serious side effects. Almost 1 out of 3 people in the United States will develop shingles in their lifetime. About 10 to 20% of people who get shingles can develop severe and persistent pain. The risk of shingles and pain increase with age. We recommend that you discuss with your healthcare provider the potential benefits of vaccination against shingles.

To date, this safety information only applies to the Shingrix vaccine; none of the COVID-19 vaccines have showed any increased risk of GBS risk as of March, 2021.

We thank the FDA for bringing this to our attention and steadfastly working with the CDC to monitor GBS occurrences as a result of certain immune system triggering events

If you believe you have experienced GBS as a result of Shingrix, you can report that to the FDA at this link  https://vaers.hhs.gov/reportevent.html

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