USA — A recent report indicates that pharmaceutical giants Pfizer and GSK are set to encounter significant competition in the respiratory syncytial virus (RSV) vaccine market.

GSK’s groundbreaking vaccine, Arexvy, which received approval from the US FDA in May, has become the first authorized RSV vaccine for use in the United States.

Analysts estimate that the current RSV vaccine market is valued at over US$5 billion and is projected to exceed US$10 billion by 2030, underscoring the immense potential of this market.

To capitalize on this opportunity, international pharmaceutical powerhouses like GSK, Pfizer, Moderna, and AstraZeneca are fervently developing vaccines to combat RSV, vying for their share in this vast market.

The year 2023 proves to be an eventful one for the multi-billion-dollar RSV vaccine market, with the aforementioned players releasing clinical data on their vaccines and seeking regulatory approval in both Europe and the US.

Notably, GSK’s Arexvy has received approval from the European Commission (EC) for preventing lower respiratory tract infections caused by RSV in adults aged 60 and above, marking it as the first RSV vaccine available across the European Union.

Despite these significant milestones, GSK’s dominance in the untapped RSV vaccine field is facing a challenge from Pfizer, which is vigorously pursuing its own RSV vaccine called Abrysvo.

A report by GlobalData, a prominent data and analytics company, highlights Pfizer’s threat to GSK’s market share.

Nancy Jaser, Pharma Analyst at GlobalData, noted that Arexvy became the first vaccine authorized for use against RSV in any population worldwide upon gaining US approval.

She further mentioned that Pfizer’s Abrysvo received FDA approval shortly thereafter, ensuring that both vaccines would be available for launch in the US around the same time in the upcoming fall, just before the winter RSV season.

Jaser added, “Therefore, GSK is not likely to experience a significant first-mover advantage for market share in the US.

“However, Arexvy may still benefit from a first-mover advantage in the EU as Pfizer’s Abrysvo has yet to gain approval for use by the EC. A decision is expected later this year.”

Although both vaccines demonstrated high efficacy in pivotal trials, Pfizer’s Abrysvo holds a crucial advantage over Arexvy.

Abrysvo is currently under review in the US as a maternal vaccine, aiming to protect infants against RSV right from birth.

The FDA’s Vaccines Advisory Committee has voted in favor of approving Abrysvo as a maternal RSV vaccine.

According to the US National Institutes of Health (NIH), RSV infects approximately 64 million people worldwide each year, resulting in around 160,000 deaths.

Additionally, a meta-analysis has revealed that acute lower respiratory infections caused by RSV in children under 5 years old accounted for approximately €4.82 billion (about US$5.22 billion) in hospitalization and outpatient visit costs worldwide in 2017.

These staggering figures underline the significant economic burden on healthcare systems, governments, and societies, emphasizing the critical need for preventing RSV infections.

The scientific community and pharmaceutical companies have been dedicated to developing RSV vaccines since the 1960s.

However, a devastating setback occurred in 1967 when a clinical trial testing the efficacy of a formalin-inactivated vaccine against RSV failed, leading to enhanced respiratory disease (ERD) and the tragic deaths of two immunized infants. This incident halted vaccine development for many years.

Further competition is anticipated from Moderna, which is developing its own RSV vaccine called mRNA-1345.

Positive Phase III data in older adults were announced in January, and Moderna plans to file for US approval in the first half of 2023.

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