GSK expects US launch of RSV vaccine with no supply issues
LONDON, March 9 (Reuters) - GSK (GSK.L) expects to launch its respiratory syncytial virus (RSV) vaccine in the U.S. this year without supply constraints and sees China as a major future market for the shot, a senior executive told Reuters.
The drugmaker is racing rival Pfizer Inc (PFE.N) to introduce the first approved RSV vaccine in the United States, where 14,000 people die annually of the lower respiratory tract disease caused by the virus.
Last week, a panel of outside advisers to the U.S. Food and Drug Administration held separate votes on the two vaccines and backed both. The FDA is scheduled to make an approval decision on the vaccines by May, and typically follows the panel's recommendations.
“We are ready to launch without capacity or supply constraints... to supply the market that we see,” Phil Dormitzer, who oversees research & development for vaccines at GSK, said in an interview on Wednesday.
GSK has already produced much of the vaccine components it anticipates needing for that launch, mainly at its plant in Wavre, Belgium, he added.
The drugmaker published late-stage data in October showing its vaccine to be 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over.
Efficacy in patients with at least two symptoms, or otherwise assessed as having severe lower respiratory disease was 94.1%.
GSK's data also showed similar efficacy in people with underlying health issues.
“I think that consistency may give us an advantage," Dormitzer said.
Pfizer's vaccine was 85.7% effective among participants with three or more symptoms, defined as severe lower respiratory tract illness, and 66.7% for two or more symptoms, according to an interim analysis of its pivotal clinical trial in the same age group.
Given different definitions of the trial endpoints across the GSK and Pfizer studies, a direct comparison of efficacy is difficult.
However, GSK has another possible advantage in that it has shown strong efficacy when its RSV shot is jointly administered with a flu vaccine, added Dormitzer, who joined GSK in late 2021 from Pfizer, where he helped develop and launch its COVID-19 vaccine with partner BioNTech (22UAy.DE).
Pfizer has not published data on RSV/flu co-administration.
GSK also sees China as an important future market for the vaccine, Dormitzer said. He cited “tremendous interest” in the company’s shingles vaccine Shingrix there. China contributed strongly to record Shingrix sales last year of 3 billion pounds ($3.55 billion).
GSK Chief Executive Emma Walmsley said in January the company is confident its RSV vaccine has "multi-billion-pound Shingrix-like annual potential."
The company has sought approval for the RSV vaccine in the European Union and Japan, but is yet to do so in China.
There are currently no RSV vaccines approved anywhere in the world.
($1 = 0.8449 pounds)
Our Standards: The Thomson Reuters Trust Principles.