The European Medicines Agency (EMA) has validated the GSK marketing authorization application (MAA) for its respiratory syncytial virus (RSV) vaccine for older adults, according to a company announcement this morning. MAAs in Europe may be eligible for accelerated assessment if the EMA’s Committee for Medicinal Products for Human Use decides the product is of major interest for public health and therapeutic innovation.
The announcement comes precisely one week following acceptance by Japanese regulators of a similar submssion for the vaccine on October 21, 2022. The pace of data submissions and positive regulatory response are hopeful signs for one of several investigational immunizations against the respiratory virus now in development. Currently there are no RSV vaccines approved for older adults.
The EMA application is based on positive results from a prespecified interim analysis of the pivotal phase 3 AReSVi-006 (Adult Respiratory Syncytial Virus) trial which demonstrated overall vaccine efficacy of 82.6% against RSV-lower respiratory tract disease (LRTD) in adults aged ≥60 years , satisfying the trial’s primary endpoint, according to GSK.
A range of prespecified secondary endpoints in the trial allowed assessment of vaccine efficacy in populations at highest risk for severe outcomes of RSV. These findings were also consistently positive with efficacy of 94.1% in patients with severe RSV-LRTD, 94.6% in participants with comorbidities, and 93.8% in adults aged 70-79 years. Efficacy of the investigational vaccine against RSV-LRTD was consistent across RSV A and B subtypes (84.6% and 80.9%, respectively), findings consistent with the significant neutralizing antibody response seen against both variants, according to the company.
The randomized placebo-controlled AReSVi-006 (Adult Respiratory Syncytial Virus) trial enrolled 25 000 participants from 17 countries to evaluate efficacy of a single dose of the adjuvanted RSVPreF3 OA investigational vaccine in adults aged ≥60 years.
The immunization was well tolerated, and the safety profile deemed favorable. Adverse events, the most common being injection site pain, fatigue, myalgia, and headache, were mild-to-moderate and transient.
“These are truly exceptional results given that today RSV remains one of the major infectious diseases without a vaccine, despite over 60 years of research,” said GSK chief scientific officer Tony Wood in an earlier GSK statement. The company believes that these robust findings suggest the potential for RSVPreF3 OA to help reduce the global burden of RSV-LRTD, and particularly among older and the most vulnerable adults.
GSK anticipates regulatory submissions based on the phase 3 data to the US Food and Drug Administration before the end of 2022.