# GSK expects US launch of RSV vaccine with no supply issues
Author:  Pal Sinha, Barnali 
Author URL: https://financedigest.com/author/pal-sinha-barnali
Published: 2023-03-09
Category: NEWS
Category URL: https://financedigest.com/category/news
Meta Title: GSK to Launch RSV Vaccine in US Without Supply Constraints
Meta Description: Learn how GSK plans to introduce their RSV vaccine in the U.S. this year, targeting China as a future market. Will they beat Pfizer to the finish line?
URL: https://financedigest.com/gsk-expects-us-launch-of-rsv-vaccine-with-no-supply-issueshtml

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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](https://www.financedigest.com/10-year-david-goliath-crusade-finally-sees-justice-for-off-plan-spanish-property-buyers.html "10 year ‘David & Goliath’ crusade finally sees justice for off-plan Spanish property buyers") 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](https://www.financedigest.com/wizz-air-loses-fight-against-67-million-in-state-aid-for-romanian-rival.html "Wizz Air loses fight against  million in state aid for Romanian rival"), 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](https://www.financedigest.com/glencore-courts-120-teck-investors-for-bid-backing-as-spinoff-vote-looms-source.html "Glencore courts 120 Teck investors for bid backing as spinoff vote looms -source") both. The [FDA is scheduled to make an approval decision on the vaccines](https://www.financedigest.com/fda-advisers-back-the-same-covid-vaccine-for-initial-shots-boosters.html "FDA advisers back the same COVID vaccine for initial shots, boosters") by May, and typically follows the panel’s recommendations.

“We are ready to launch without capacity or [supply constraints..](https://www.financedigest.com/oil-prices-fluctuate-amid-supply-constraints-and-demand-concerns.html "Oil prices fluctuate amid supply constraints and demand concerns"). to [supply](https://www.financedigest.com/in-u-turn-iea-sees-world-weathering-lost-russian-oil-supply.html "In U-turn, IEA sees world weathering lost Russian oil 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](https://www.financedigest.com/interoperability-of-data-to-accelerate-the-flu-vaccines-market.html "Interoperability of data to accelerate the Flu Vaccines Market") 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](https://www.financedigest.com/havensrock-thrive-app-launched-by-punter-southall-health-and-protection-to-address-workplace-mental-health-issues.html "Havensrock Thrive App launched by Punter Southall Health and Protection to address workplace mental 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](https://www.financedigest.com/half-of-small-businesses-operating-in-the-red-according-to-analysis-of-250k-sme-database.html "Half of small businesses operating in the red, according to analysis of 250K SME database") 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](https://www.financedigest.com/avaloq-enlarges-innovation-ecosystem-through-launch-of-developer-portal.html "Avaloq enlarges innovation ecosystem through launch of developer portal") 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](https://www.financedigest.com/first-foreign-covid-vaccines-head-to-china-from-germany.html "First foreign COVID vaccines head to China from Germany"), 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](https://www.financedigest.com/commonenergy-mistakes-costing-homeowners-hundreds-of-pounds-each-year.html "Commonenergy mistakes costing homeowners hundreds of pounds each year") ($3.55 billion).

GSK [Chief Executive](https://www.financedigest.com/exotix-draws-sberbanks-us-chief-executive-in-triple-hire-to-extend-global-capabilities.html "Exotix Draws Sberbank’s US Chief Executive in Triple Hire to Extend Global Capabilities") 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](https://www.financedigest.com/explainer-why-malaysia-is-considering-a-ban-on-palm-oil-exports-to-the-european-union.html "Explainer-Why Malaysia is considering a ban on palm oil exports to the European Union") and Japan, but is yet to do so in China.

There are currently no RSV vaccines approved [anywhere in the world](https://www.financedigest.com/be-the-digital-eyes-and-ears-of-your-business-from-anywhere-in-the-world.html "Be the digital eyes and ears of your business – from 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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