United Kingdom: GlaxoSmithKline, plc. (GSK) on Wednesday, 3rd May 2023 announced that it has received US-FDA approval for its Respiratory Syncytial Virus (RSV) Vaccine. RSV is a highly contagious virus belonging to the Pneumoviridae family which affects the lungs and breathing passages in individuals of all age groups. RSV infection is seasonal, which starts during the fall and peaks in the winter. RSV leads to lower respiratory tract disease (LRTD) that affects the lungs in older adults which affects the lungs and can cause life-threatening pneumonia and bronchiolitis. According to the Centers for Disease Control and Prevention (CDC), every year RSV contributes to around 6,000-10,000 deaths among adults 65 years of age and older in the United States.

Arexvy is an adjuvanted vaccine that contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant. The vaccine indicated prevention of RSV-LRTD in individuals 60 years of age and older in the United States. The vaccine at present has only received approval in the United States. The trade name proposed for the vaccine remains subject to regulatory approval outside the United States.

The vaccine received US-FDA approval after it demonstrated its safety and effectiveness in a study in which around 12,500 participants received Arexvy and about 12,500 participants had received a placebo. In the participants who received the vaccine and the participants who have received a placebo, it significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%. The vaccine remained well tolerated among the individuals who received it and demonstrated an acceptable safety profile. Some of the mild to moderate and transient adverse effects of the vaccine included pain at injection site, fatigue, myalgia, headache, and arthralgia.

According to the Chief Scientific Officer, GSK, “This day marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”

According to TechSci Research, GSK and Pfizer, Inc. has remained neck-and-neck in RSV vaccine development, however, this approval has made GSK the first company to enter the market. Being the first company to develop and launch a vaccine has strengthened the positioning of GSK among its competitors such as Pfizer, Moderna, Bavarian Nordic, among others. This approval has demonstrated the company's innovation, scientific prowess, and ability to address critical public health needs. This first-mover advantage can create a significant competitive edge for the company. Other companies would need to catch up, giving the pioneering company a head start in terms of market share, brand recognition, and customer loyalty. It is expected that Pfizer’s RSV vaccine will also receive approval by the end of this month.