August 29, 2024, GSKAnnounced that,EU Commission Approves GSK's Arexvy Expanded Age Indication, this is the first one used forHigh-risk adults aged 50-59The RSV vaccine. Additionally, coincidentally,GSKOn August 27, on the Clinicaltrials.gov websiteRegistered the Phase 1 Clinical Trial of RSV mRNA Vaccine. It can be seen that its continuous efforts in the RSV vaccine track.

In May 2023, Arexvy was first approved by the FDA for marketing, and subsequently received approval in the EU and Japan.Used to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and above. As the world's first marketed RSV vaccine, Arexvy has performed quite well in sales, generating revenue of £1.238 billion (approximately $1.545 billion) within nine months of its launch, quickly becoming..."Blockbuster" Drug List.

On June 7, 2024, GSK announced that the FDA approved the expansion of Arexvy's indication to include adults aged 50-59 at high risk for RSV.. Nowadays, the applicable age range has also been approved in Europe, which will cover and protect more people in the region. It is estimated that there are approximately 65 million adults aged between 50-59 in the EU/EEA.It is estimated that 20 million of these people (1/3) have at least one underlying condition that increases their risk of RSV disease.。

Apart from the United States and Europe,GSK alsoRegulatory applications have been submitted in other regions, including Japan., to introduce ArexvyThe use is expanded to adults aged 50-59 with higher risk.In addition,Evaluate ThisThe trial on the immunogenicity and safety of the vaccine in adults aged 18-49 at higher risk and in immunocompromised adults aged 18 and above is expected to be announced later in 2024.。

As for China, GSK had also registered in August this year on the Clinicaltrials.gov website.Registered the Phase 3 Clinical Trial of Recombinant RSV Vaccine in China. This is a Phase 3, randomized, controlled, partially blinded, immunogenicity bridging study to evaluate the immunogenicity, reactogenicity, safety, and incidence of RSV-related respiratory diseases following a single dose of GSK's RSVPreF3 OA investigational vaccine in adults aged 60 years and above. The study plans to enroll 2,600 healthy individuals over 60 years old, with the primary endpoint follow-up expected to be completed by March 2025.

Currently,Three RSV vaccines have been approved for marketing worldwide: GSK's Arexvy (monovalent) and Pfizer's Abrysvo (bivalent), both of which are recombinant protein vaccines, and Moderna's RSV mRNA vaccine mRESVIA (monovalent), which was just approved for marketing in the United States in May 2024.

And now,GSK is set to advance againRSV mRNA VaccineFieldAccording to the Clinicaltrials.gov website, GSK has registered a Phase 1, first-in-human (FTiH), observer-blinded, randomized, controlled study to evaluate the safety, reactogenicity, and immune response of various doses of an mRNA-based RSV investigational vaccine in healthy participants aged 18-45. This Phase 1 clinical trial plans to enroll 210 healthy adult volunteers aged 18-45 and will test six different designs of RSV mRNA vaccines.Expected to be completed in June 2026。

It is worth noting that,In the first half of 2024, the revenue of Arexvy was 244 million pounds.(Approximately $314 million). In Q2 of 2024, Arexvy's revenue was £62 million, with £56 million coming from the U.S. market. Meanwhile, its competitor Pfizer reported Abrysvo revenues of $201 million for the first half of 2024 and $56 million for Q2 2024.Although Arexvy's market performance was better than Abrysvo's, its performance this quarter was still disappointing.According to a report by Reuters, in terms of retail, "the total sales of the vaccine reached 80 million U.S. dollars, which was lower than the analysts' expected approximately 90 million U.S. dollars."

Related Reading:GSK Lowers Full-Year Vaccine Sales Outlook as Shingrix Revenue Drops 4% and Arexvy Sales Fall Short of Expectations in Q2 2024

Arexvy Faces Potential Hurdles. In June this year, the Advisory Committee on Immunization Practices (ACIP) of the US CDC unanimously voted to recommend that adults aged 75 and above, and those aged 60 to 74 with underlying medical conditions putting them at high risk for severe illness, receive a single lifetime dose of the vaccine. Additionally, ACIP also voted on recommendations regarding the use of RSV vaccines and target populations, suggesting deferring vaccination for adults under 60 due to safety concerns.Although the FDA had previously approved GSK's Arexvy for use in people aged 50-59, the committee still recommended delaying it for a period of time., after collecting and analyzing more data, make a decision.

Related Reading:-2.04%, -3.57%, -11.01%! Stock Prices of Three Major RSV Vaccine Manufacturers Drop Collectively, Facing Potential Market Shrinkage Risk

In fact, this does not only affect Arexvy.The market, but rather the entire RSV vaccine market has shrunk dramatically. A London-based health analytics firmAirfinity has cut the value of the RSV market for elderly Americans from $4.7 billion to $1.7 billion by 2030.。

However, this has not affected GSK's confidence in the RSV vaccine market. GSK CEO Emma Walmsley has stated that she firmly believes "2025 will be a year of growth, and peak-year sales performance is guaranteed."GSK Sets Peak Annual Sales of Arexvy at £3 Billion. In addition, GSK has started to make new moves.RSV mRNA VaccineIt can also be seen that,It is also optimistic about the long-term market value of the RSV vaccine.。