GSK Sues Pfizer for Patent Violations over its RSV Vaccine
Infectious Diseases 03/08/2023 •
RSV
GSK has sued Pfizer for patent violations over its RSV vaccine

Merely months after securing US Food and Drug Administration (FDA) approval for its Respiratory Syncytial Virus (RSV) vaccine, British pharma giant GSK has taken Pfizer to court for patent violations. 

GSK filed the lawsuit in a US federal court in Delaware on Wednesday alleging that Pfizer’s RSV vaccine, Abrysvo, violates four patents surrounding the antigen that GSK uses in its own RSV vaccine, Arexvy, Reuters reported. 

The US FDA approved both vaccines in late May, to be administered to adults aged over 60 years. RSV is common during winter seasons and kills over 100,000 children aged under five every year. While its symptoms are considered non-threatening to adults, over 14,000 adults aged above 65 in the US die due to RSV every year. The virus is estimated to affect around 64 million people every year globally, with an annual death toll of 160,000. 

In response to the lawsuit, Pfizer asserted confidence in its intellectual property position and added that it will strongly defend its case. 

The market for RSV vaccine is estimated to reach $10 billion by 2030, according to analysts. Other contenders in this market are Sanofi and its partner AstraZeneca, that are working on a prophylactic monoclonal antibody for infants, and Bavarian Nordic, and Moderna that are currently in Phase 3 clinical trials for their vaccines. 

The race to make an RSV vaccine possible started several decades ago, in the late 1960s. Between 1966 and 1968, a promising clinical trial for an RSV vaccine had to be shut down after two young children that participated in the trial died and many more children ended up being hospitalized. 

It wasn’t until years later that scientists discovered that the virus that caused RSV shifted shapes, similar to SARS-CoV-2. Finally, in 2013, scientists from the National Institutes of Health (NIH) discovered a way to freeze the shape-shifting protein in one of its forms, thus making it possible to develop an antigen. 

Common during winter seasons, RSV garnered attention during the COVID-19 pandemic when it filled hospitals across the US with ailing children and older adults in 2021 and 2022. 

Image Credits: NIAID.

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