GSK expects US launch of RSV vaccine with no supply issues
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[March 09, 2023]
By Maggie Fick
LONDON (Reuters) -GSK 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 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.
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GSK (GlaxoSmithKline) logo is seen in
this illustration, August 10, 2022. REUTERS/Dado Ruvic/Illustration
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.
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)
(Reporting by Maggie Fick; additional reporting by Natalie Grover;
Editing by Bill Berkrot and Sharon Singleton)
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