GSK's Blockbuster RSV Vaccine Faces Setback in U.S., Casting Shadow Over China Market Entry

On June 26, the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention voted to approve a new routine vaccination recommendation for Respiratory Syncytial Virus (RSV) vaccines: the target population for RSV vaccination has been adjusted from 60 years and above to 75 years and above.

The U.S. CDC also emphasized that only people aged 60 to 74 who are at high risk of severe respiratory syncytial pneumonia need to receive the RSV vaccine.

RSV is a virus that causes acute lower respiratory tract infections, with susceptible populations mainly being infants, young children, and the elderly. The research report points out that from 2009 to 2019,Among Chinese patients with severe respiratory infections, 28.5% are infected with the influenza virus, and 16.8% are infected with RSV.The infection rate of RSV in pneumonia patients is as high as 22.1%.RSV vaccine is considered to be the adult vaccine with the most market potential after the HPV vaccine.The main reason is the lack of effective therapeutic drugs on the market, and vaccination is the best means to prevent infection.

The development of RSV vaccines and drugs has been fraught with challenges, with initial results only emerging after 60 years of technological efforts.The world's first RSV vaccine was launched in May 2023, produced by GSK.Subsequently, Pfizer and Moderna also launched RSV vaccines, with Pfizer's vaccine expanding the indications to include pregnant women.

The main target population for the three RSV vaccines is the elderly. GSK's vaccine has been approved in the United States for the prevention of lung infections caused by respiratory syncytial virus in adults aged 60 and above, with the vaccination scope expanded to include adults aged 50-59 in early June this year. The recent U.S. demand to reduce the vaccination scope undoubtedly touches the core interests of vaccine companies.

GSK stated that the ACIP has not yet voted on the vaccination for adults aged 50-59, and GSK is actively working to advance clinical data to support future policy decisions. However, it is clear that，The recommendation against use in the crucial population aged 60 and above has significantly dampened the enthusiasm for the RSV vaccine.

Even more unlucky were GSK's agents. Last October,Chongqing Zhifei Biological Products Co., Ltd. Announces Preliminary Agreements with Two Companies, Gaining Exclusive Rights to Distribute Their RSV Vaccine in ChinaAccording to the original plan, Chongqing Zhifei Biological Products Co., Ltd. could quickly catch up with the RSV trend. Whether the vaccination recommendations from the U.S. Centers for Disease Control and Prevention will influence the approval process by China's National Medical Products Administration is currently the most pressing concern for domestic stakeholders.

GSK Stumbled

RSV infects the elderly and infants, with the most vulnerable group being children under 2 years old.Because infants have not yet developed either congenital or acquired immunity, the risk of vaccine-mediated disease after vaccination is very high. Therefore, the development of RSV vaccine indications for infants and young children is highly challenging. It has taken companies like GSK decades of exploration to finally develop RSV vaccines for the elderly in recent years, demonstrating the immense difficulty of such development.

GSK is now at a critical moment of confrontation with Pfizer.Arexvy Vaccine Approved for Less Than a Month, Pfizer’s Competing Product Hits the MarketIn terms of protective efficacy, GSK's vaccine, with the addition of an adjuvant, has a higher protection rate than others, reaching 80%; Pfizer's vaccine has a protection rate of around 60%; Moderna's RSV vaccine was only launched in May this year, using the mRNA technology platform. The CDC disclosed that the vaccine’s efficacy dropped by more than 30% after over a year of vaccination. Comparing these three, GSK should be the clear winner.

In terms of competitive results, GSK does indeed have an advantage. In 2023, the sales of GSK's RSV vaccine reached $1.564 billion, while Pfizer's sales were $890 million, only half of GSK's.GSK CEO Emma Walmsley once stated that its RSV vaccine has captured two-thirds of the U.S. market.

Pfizer's advantage lies in market expansion. On June 24, the UK NHS announced that it had signed a procurement order with Pfizer for approximately 5 million doses of the RSV vaccine. GSK lost its home market to Pfizer, which shocked outsiders. Unexpectedly, there was an even more serious issue: A recommendation from the US CDC put the companies that invested significant human and financial resources into development at risk of facing a shrinking market.

The US CDC believes that, according toFirst Real-World Data Post-Vaccination in the Population Aged 60 and AboveAfter evaluating the effectiveness of the RSV vaccine, assessing the disease burden, and conducting a cost-effectiveness analysis, the decision to modify vaccination recommendations was made. Mandy Cohen, Director of the U.S. Centers for Disease Control and Prevention, clarified: "A single dose of the respiratory syncytial virus vaccine should be administered only to individuals aged 75 and older, as well as those between 60 and 74 years old with chronic conditions or residing in nursing homes."

In the United States, vaccine administration must strictly follow the recommendations of the committee.The current period is the peak vaccination season for RSV vaccines. Following the recommendation, GSK’s RSV vaccine sales are expected to be significantly impacted. Take GSK’s Arexvy as an example: this RSV vaccine also requires out-of-pocket payment in the United States, costing approximately $290 per dose, with only some commercial insurance plans covering the vaccine cost.

Currently, the application scope of RSV vaccines has been greatly compressed, with GSK being hit the hardest. Jefferies analyst Peter Welford stated,New recommendations could potentially reduce the U.S. RSV vaccine market from 93 million doses to approximately 55 million doses for the 2024-2025 period.

What is the prospect of the market in China?

This year, five RSV vaccines produced in China have submitted clinical trial applications, including those from Shijiazhuang Pharmaceutical Group and Guangzhou SiAnSen Biotech. The overall development of RSV vaccines in China is still in the early stages. Companies like Chongqing Zhifei Biological Products Co., Ltd. and Clover Biopharmaceuticals have already made strategic investments. Among them, the RSV vaccine developed by Advaccine has progressed to phase 2 clinical trials, primarily targeting research on the elderly population.Ames Biotech expects its self-developed RSV vaccine to be approved after 2026.

In the short term, the competition for the RSV market in China is likely to occur among multinational pharmaceutical companies. Currently, GSK, Pfizer, and Sanofi have all applied for clinical research on RSV vaccines in China. GSK Chief Commercial Officer Luke Miels has confidently expressed his view on the Chinese market: "The pie for RSV vaccines will only get bigger."GSK's global strategic plan for its RSV vaccine is still in its early stages, with the Chinese market set to become the largest target in the future.”

GSK's commercialization strategy for the RSV vaccine is also very clear: it has already handed over this star product to Chongqing Zhifei Biological Products Co., Ltd. By the end of 2023,GSK's Arexvy has been approved for marketing in Hong Kong, China, and is suitable for the prevention of lower respiratory tract diseases caused by RSV in people aged 60 and above.

However, whether it is the shingles vaccine or the RSV vaccine, GSK and distributors have always faced an issue of cognitive difference:How Many Elderly People in China Are Willing to Pay for Vaccination?

Chinese adults do not have the habit of voluntarily getting vaccinated,The vaccination rate for the flu vaccine in recent years has only been around 3%.RSV vaccines lag far behind flu vaccines in terms of awareness and pricing, necessitating prolonged consumer education.

Moreover, in Hong Kong, GSK's RSV vaccine is priced as high as HK$3,300 per shot. At such a price, it would be far from easy to gain a foothold in the mainland market.

Author｜Yang Xixia

Editor｜Jiang Yun, Jia Ting

Operator | Zhu Ying

Illustration｜Visual China

Statement: Original content by Jian Shi Ju, please do not reprint without permission.