GSK Secures First Approval for RSV Vaccine in EU

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GSK has achieved a significant milestone by securing the first approval for a vaccine against respiratory syncytial virus (RSV) in the European Union

The European Commission has given the green light for GSK’s Arexvy to be used in older adults aged 60 or above. This approval comes just a little over a month after GSK received approval in the United States, allowing the company to maintain a slight lead over its closest competitor, Pfizer, in the race to develop an RSV vaccine. Pfizer recently obtained FDA approval for its Abrysvo shot.

In a statement, GSK announced that it expects to launch Arexvy in the first EU markets in time for the 2023/24 RSV season, which typically begins in the autumn. Pfizer filed for approval of Abrysvo in the EU around four months after GSK’s vaccine, making it challenging for Pfizer to be ready in time for the upcoming season. GSK’s Chief Scientific Officer, Tony Wood, expressed confidence in their manufacturing capability and readiness to deliver the vaccine as countries start to roll out their vaccination programs. However, the launch of Arexvy in the EU will depend on individual member state decisions regarding access and reimbursement.

According to GSK, RSV leads to more than 270,000 hospitalizations and approximately 20,000 in-hospital deaths among individuals aged 60 and above in Europe each year.

GSK’s approval in the EU is based on data from the phase 3 AReSVi-006 study, which demonstrated an estimated 83% protection against RSV-confirmed lower respiratory tract infections for at least six months. However, due to the relatively low number of infections in the study, the company has re-randomized subjects for a second season to receive either the vaccine or a placebo. This additional data will provide insights into efficacy and the duration of protection, with results expected later this year.

GSK is also gathering a dataset to support the use of Arexvy in individuals aged 50 to 59 who are at higher risk of complications from RSV infection.

Later this month, an advisory committee from the Centers for Disease Control and Prevention (CDC) will make recommendations on the appropriate use of both GSK and Pfizer vaccines in the United States. GSK’s vaccine is also undergoing regulatory review in Japan, where the company anticipates being the first to enter the market.

The RSV vaccine market is estimated to be worth between $5 billion and $10 billion annually worldwide. Analysts tend to favor GSK’s vaccine due to its higher efficacy demonstrated in clinical trials. Both Pfizer and GSK anticipate blockbuster sales for their vaccines but will need to keep an eye on competing candidates from Moderna and Bavarian Nordic, which are in the advanced stages of development.

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