Panelists voted 11-0 in favor of approving Shingrix for adults over 50. The FDA usually follows the non-binding recommendations of its advisory panels, but not always. The final decision will be in October 2017.
According to Dr. Emmanuel Hanon, senior vice president and head of vaccines research and development at GlaxoSmithKline (GSK):
Thursday’s vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system.”
If Shingrix is approved next month, it will dramatically change the market for shingles vaccines. The only alternative in the U.S. is Merck’s Zostavax®, a live virus vaccine that can trigger severe shingles infections — or even death in immune-compromised patients.
The panelists were impressed by positive data from a Phase III clinical trial in June 2017 showing that Shingrix induced a strong immune response in adults over 50 who were vaccinated with Zostavax.
People who received Zostavax at least 5 years before being vaccinated with Shingrix showed a similar immune response compared to people who had never been vaccinated with Zostavax.
Shingrix is a recombinant sub-unit vaccine rather than a live attenuated virus like Zostavax. Live virus vaccines can’t be used in patients who are sick because their immune system may not be strong enough to fight off the virus. Shingrix would not carry this deadly risk.
Shingrix is that it is much easier to manufacture and transport, so the company intends to have a global launch from the beginning. Shingrix is a heat-stable vaccine, unlike Zostavax which requires refrigeration.
Merck is currently facing several Zostavax lawsuits from people who suffered severe shingles, blindness, paralysis, brain damage, or death.