New Label Precaution Issued for Shingles Vaccine and Guillain-Barré Syndrome

The U.S. Food and Drug Administration (FDA) Safety Communication group issued a notice on March 24, 2021, to inform the public and healthcare providers that the FDA has required and approved an updated safety label change to the Prescribing Information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) that includes additional safety information based on post-marketing experience.  

The FDA required GlaxoSmithKline (GSK), the manufacturer of Shingrix, to revise the Prescribing Information to include the following language in the Warnings and Precautions section: In a post-marketing observational study, an increased risk of Guillain-Barré syndrome (GBS) was observed during the 42 days following vaccination with Shingrix.

GSK’s top priority is patient safety and is committed to monitoring and ensuring the safety of all their products, including Shingrix (Recombinant Zoster Vaccine/RZV).

FDA stated it 'evaluated data from a postmarketing observational study that assessed the risk of GBS following vaccination with Shingrix. Based on this evaluation, FDA has determined that the results of this observational study show an association of GBS with Shingrix. Still, that available evidence is insufficient to establish a causal relationship.'

Guillain-Barré syndrome is a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. While its cause is not fully understood, the syndrome often follows infection with a virus or bacteria. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS.

According to the CDC, GBS is rare, and data on the risk of GBS following HZ (herpes zoster or “shingles”) and vaccination are limited. Clinical trials, observational studies, and the risk-benefit analysis confirm the considerable benefits of RZV (SHINGRIX) vaccination in preventing HZ, severe disease, and complications.

The Shingrix vaccine received FDA approval on October 20, 2017, to prevent herpes zoster (shingles) in adults aged 50 years and older. In one clinical trial, compared to placebo, Shingrix reduced the incidence of shingles by 97% in individuals 50 years and older, says the FDA.

GSK's Shingrix vaccine is administered as a two-dose series, with the second dose given anytime between 2 and 6 months after the first dose.

'Although no medical product, such as vaccines or drugs, is 100% safe or effective, Shingrix has a strong safety record,' says the FDA.

GSK remains confident in the favorable benefit-risk profile of Shingrix for the prevention of shingles. GSK will continue to communicate with FDA and CDC on post-marketing safety monitoring for Shingrix.