Japanese regulator accepts GSK regulatory submission for RSV vaccine candidate in older adults

JAPAN — The Japanese Ministry of Health, Labor, and Welfare (MHLW) has agreed to review GSK’s new drug application (NDA) for its respiratory syncytial virus (RSV) vaccine candidate for use in older adults.

The proposed indication is for the prevention of RSV-associated lower respiratory tract diseases (LRTD) in adults aged 60 and up.

The submission was made by GSK in response to the positive interim assessment findings from the multi-country, placebo-controlled, randomized, observer-blind Phase III AReSVi-006 clinical trial.

Data unveiled by GSK showed respiratory syncytial virus (RSV) vaccine was 82.6% effective in a keenly watched late-stage study involving older adults.

The trial, which included approximately 25,000 adults aged 60 and up, revealed that the vaccine was 94.1% effective against severe lower respiratory tract disease caused by RSV infection, according to the British drugmaker.

RSV is a leading cause of pneumonia in toddlers and the elderly, causing thousands of hospitalizations and deaths each year, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine.

RSV symptoms are similar to a cold and are usually harmless in adults, but the US CDC reports that children under the age of five are the most affected. Adults over the age of 65 are the next most vulnerable group.

RSV causes over 420,000 hospitalizations and 29,000 deaths in adults in industrialized countries, including approximately 57,000 and 4,000, respectively in Japan.

Similarly, U.S. drugmaker Pfizer in August disclosed positive Phase III data on its rival RSV vaccine in older adults.

According to the company, efficacy against RSV-associated lower respiratory tract illness with two or more symptoms was 66.7%, while efficacy against severe disease defined by three or more symptoms was 85.7%.

A late-stage readout on Johnson & Johnson’s RSV vaccine in older adults is also expected by the end of 2022, as is an interim look at Moderna’s competitor shot’s Phase III data this winter.

The latest development comes after GSK received FDA approval for Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) to prevent pertussis in newborn infants in pregnant women in the third trimester.

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