Product News and Recalls

Zostavax Competitor Wins Unanimous Recommendation for Approval

shingrix wins approval recommendationAfter considering the data, every member of an FDA advisory panel convened this month voted to recommend the approval of Shingrix – a new shingles vaccine developed and marketed by GlaxoSmithKline.

Data was not based solely on efficacy, or effectiveness. Rather, the data also took the vaccine’s safety into consideration. Panel members were “very impressed” with that data on both fronts and – according to Reuters – believe that Shingrix is actually an improvement over Merck’s Zostavax vaccine; the only other shingles vaccine currently available.

A safer and more effective alternative to Zostavax would certainly be a step in the right direction. Data indicates that Zostavax’s effectiveness is a paltry 51 percent and, in many cases, can actually cause the very disease it was made to prevent. Should a patient contract shingles at that point, the pain and disfigurement from the condition may actually be the least of that person’s worries. Side effects of contracting shingles can also include meningitis, encephalitis, stroke, and congestive heart failure. 90 patients died from shingles-related complications from 1990 to 2015 and over 1,000 instances of serious adverse side effects have been directly linked to Zostavax.

Given the current state of efforts at preventing shingles in those aged 50 or over then, it is easy to see why officials would be enthused at the prospect of a new entry into the arena. And while a panel recommendation is not binding to the FDA as a whole, a unanimous decision coupled with a high degree of enthusiasm lends near-certainty to Shingrix’s eventual release to the market.

The data for the vaccine is impressive. Four year follow-ups with trial participants showed a 90 percent effectiveness rate in patients over the age of 70 while side effects of the drug were similar to those taking a placebo. Those that had been given Shingrix who also eventually contracted shingles experienced a reduced level of the nerve pain that plagues those affected by the condition.

If approved and initial trial data holds true, Shingrix could become a major product for GSK, with sales of the vaccine expected to top $1 billion by 2023. At the same time, Merck’s grip on the shingles vaccine market will loosen. Zostavax should generate about $730 million for the drugmaker in 2017 with subsequent years seeing sales dwindling as competitors chip away at its market position.

Executives at Merck are no doubt exploring their next options as they lose shingles revenue to competitors. For starters, they might consider creating something that doesn’t give people the very condition they’re trying to prevent in the first place.