In a significant lift for GlaxoSmithKline's new shingles vaccine, the CDC committee in charge of vaccination policy in the U.S. endorsed Shingrix over the older shot, Merck's Zostavax. If confirmed, the decision will give the newly approved GSK product a long launch runway, as tens of millions U.S. adults would be encouraged to get the two-dose option.
By an 8-7 vote on Wednesday, the CDC's Advisory Committee on Immunization Practices recommended Shingrix over Merck's vaccine. The group further recommended the shot for people 50 and older—versus previous shingles vaccination guidelines of 60 and older—and for people who've previously received Zostavax. The recommendations now go to CDC officials for final approval.
Together, GSK reports that the votes expand its vaccine's potential reach by about 62 million adults over the current market. That's because about 42 million people in the U.S. are in the 50 to 59 age range, the drugmaker said in a release, and about 20 million have previously received Zostavax.
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Obviously, that's good news for an important new launch at the drugmaker. Shingrix is one of three products CEO Emma Walmsley has said are a near-term focus for GSK, and analysts predict it will climb to blockbuster status by 2022. GSK reports that the price for its new shot is $280 for a two-dose course.
The Merck and GSK vaccines haven't been tested head to head, but studies have shown Shingrix offers higher protection against the infection—90% or higher across all age groups—with the advantage more pronounced in older groups.
The FDA only approved Shingrix on Friday, making ACIP's vote the second major boost for the program in under a week. Before the approval, the company worked to build the case for Shingrix by touting data showing its vaccine offers lasting protection and can provide protection for those who’ve previously received Zostavax. Earlier Zostavax studies showed that vaccine's protection wanes over time.
Merck's Zostavax won approval in 2006 and generated $685 million last year, but is seen as inferior to Shingrix. Still, some panel experts were cautious about issuing preferential guidance for such a new vaccine and adjuvant that hasn't been used in the real world. One expert said she was worried supply could come up as an issue for a popular new shot.
But the panel also weighed evidence showing a preferential decision for GSK's shot will substantially reduce cases of shingles and a painful complication called postherpetic neuralgia over the years, and that Shingrix is more cost-effective. In the end, it was the closest vote committee chair Nancy Bennett, M.D., said she has seen during her time on ACIP.
A notoriously painful condition that's caused by latent varicella infection, shingles affects about 1 in 3 people in the U.S., according to the CDC. The risk increases with age as immune systems become less able to fend off infections.
Also on Wednesday, GSK reported third-quarter vaccine sales that were flat versus the same period last year. Meningitis B vaccine Bexsero was one bright spot, jumping 26% in sales over last year's third quarter due to more public and private sales in Europe and increased demand in the U.S. The vaccine generated £176 million ($233 million) in sales during the period.