GSK gets positive opinion from EU for RSV vaccine
With GSK and Pfizer locked in a head-to-head race for approval of their respiratory syncytial virus (RSV) vaccines, the former company has moved a step closer in Europe, after it received a positive opinion from the medicine authority in the region.
The decision was made by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for the potential vaccine’s prevention of lower respiratory tract disease caused by RSV (RSV-LRTD) in adults aged 60 years and older.
As a result of the positive opinion, GSK’s marketing application is now awaiting the European Commission’s final decision for approval. The final decision is expected by July 2023.
The CHMP made its decision based on data from GSK’s phase 3 trial, which showed that its vaccine candidate had an overall efficacy rate of 82.6% against RSV-LRTD in adults aged 60 years and older. Efficacy in older adults with at least one underlying condition rose to 94.6%.
The data were enough to take the candidate closer to potentially becoming the first vaccine for older adults against RSV. According to GSK, RSV causes over 270,000 hospitalizations and 20,000 in-hospital deaths in adults aged 60 years and older each year in Europe.
The vaccine itself contains a recombinant subunit RSV prefusion F glycoprotein antigen (RSVPreF3), combined with the company’s proprietary AS01E adjuvant.
Earlier this year, the US Food and Drug Administration (FDA)’s advisory committee made the same decision as its European counterpart by recommending GSK’s vaccine for approval. The committee voted unanimously in favor of its effectiveness and 10-2 that it exhibited a favorable safety profile.
In first quarter financials for 2023, GSK stated that it expects a decision from the FDA on its vaccine by May 3 – lining it up for a potential first approval and commercialization in the coming months.
Luke Miels, chief commercial officer at GSK, stated on an investor call that he expected the company to be the first company to secure approvals in ‘major markets’ for an RSV vaccine, including the US, Europe, and in Japan.
In terms of the company’s preparation for commercialization, Miels said, “Our teams have begun disease awareness activities where needed, and our launch preparations are well underway. Overall, we have a competitive vaccine profile with compelling clinical evidence and multi-billion, Shingrix-like annual sales potential, and we look forward to keeping you updated as we launch this important vaccine.”
