FDA public hearing on safety of Shingrix as alternative to Zostavax

New shingles vaccine may be safer alternative to existing vaccine.

On September 13, 2017, the U.S. Food and Drug Administration or FDA, the main federal agency responsible for approving drugs and medications as safe for use by the public, will hold a public hearing on the safety of Shingrix, a new shingles vaccine under development by pharmaceutical giant GlaxoSmithKline or GSK. The hearing will be an open session of the Vaccines and Related Biological Products Committee, known as the VRBPAC, which will provide background information to the public as well as take written and oral testimony in its consideration of evidence on the "safety and effectiveness" of the vaccine.

The hearing follows GSK's application for FDA approval of Shingrix. Similar requests have been made to regulatory authorities in at least Japan, Canada and the European Union, according to a June 2017 GSK news release.

Background: Zostavax

Since 2006, Zostavax, manufactured by Merck, has been the only FDA-approved shingles vaccine available to Americans. Shingles, a condition caused by the dormant chickenpox virus in the body, is usually manifest by a painful, uncomfortable blistering rash. According to the Mayo Clinic, shingles is not usually life threatening, but can cause in some cases, especially in older patients, loss of vision or hearing, severe skin infections, long-term pain from damage to nerves and other neurological problems like encephalitis, balancing difficulty or paralysis of the face.

For these reasons, a reliable vaccine to lessen the chance of shingles is important, but Zostavax has not been the answer for many patients. Experts have challenged statistics released by Merck about the success rates of the vaccine and it has been the subject of multiple lawsuits in the U.S. alleging unexpected serious side effects. In addition, resistance to shingles from Zostavax has been known to fade over time.

Some of the suits have been filed in federal and state courts in Pennsylvania, alleging that Merck failed to warn users of the potential for dangerous side effects. Recently, in the summer of 2017, 18 plaintiffs from 11 different states filed suit against Merck in New Jersey state court, again alleging failure to warn about serious side effects from Zostavax like contraction of shingles itself, post-herpetic neuralgia, scarring, blindness, brain damage and paralysis, according to the Daily Hornet.

FiercePharma also reported that the suit also alleges these legal claims in addition to failure to warn: negligence, breach of implied and express warranty, misrepresentation, unjust enrichment and defective design.

Hope for Shingrix

In June 2017, GSK announced that a major phase 3 study had produced positive revaccination results for people over 50 who had previously received Zostavax. GSK also wrote that two other phase 3 studies had "demonstrated efficacy against shingles above 90 percent, independent of age ... as well as sustained efficacy over the entire follow-up period of four years."

FiercePharma cites officials from the U.S. Centers for Disease Control and Prevention or CDC as saying in June 2017 that, based on data current then, they were "likely to recommend the GSK vaccine over Merck's shot" should Shingrix be approved by the FDA. FiercePharma also reported that Evaluate, a "life science commercial intelligence firm," named Shingrix as the "most valuable vaccine R&D project in the industry."

All eyes are on the FDA as safety advocates await its approval decision, hoping for a safer shingles vaccine to help protect older Americans from painful, sometimes dangerous shingles.

Anyone who believes that Zostavax may have caused harm should speak with a lawyer about potential legal remedies, including a possible lawsuit.

The lawyers at the Houston office of Reich & Binstock represent clients throughout Texas and across the nation injured by dangerous pharmaceutical products.