Moderna initiates regulatory submissions for RSV vaccine, aiming to enter multibillion-dollar market

USA — Moderna, a renowned vaccine manufacturer, has announced that it has commenced a rolling submission to the U.S. Food and Drug Administration (FDA) for its respiratory syncytial virus (RSV) vaccine in adults aged 60 years and older.

This move positions Moderna to compete with Pfizer and GSK in what is projected to be a lucrative multibillion-dollar market.

In addition to the FDA submission, Moderna has also filed for regulatory review of its RSV vaccine candidate in Australia, Europe, and Switzerland.

The company aims to secure approvals from multiple regulatory bodies, broadening its potential market reach.

The application to the FDA is supported by positive data from the phase 3 ConquerRSV study, which involved approximately 37,000 adults aged 60 years or older from various countries.

Moderna’s RSV vaccine is a crucial product in the company’s pipeline, expected to drive sales growth next year as it transitions away from a possible net loss in the current year.

Respiratory syncytial virus (RSV) primarily affects the lower respiratory tract, posing a significant risk to infants, young children, and older adults.

Annually, RSV causes over 30 million infections in infants worldwide, with 10% of cases requiring hospitalization.

Among the elderly, RSV infections can be as severe as influenza, resulting in 11,000 to 17,000 deaths and up to 170,000 RSV-related hospitalizations each year.

Moderna’s RSV vaccine demonstrated promising results in a late-stage trial, showing an efficacy of 82.4% against RSV lower respiratory tract disease with three or more symptoms in older adults.

In January 2023, the FDA granted Moderna’s mRNA-1345 breakthrough therapy designation for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 years or older.

Additionally, the FDA granted fast-track designation for the vaccine in August 2021.

Moderna’s RSV vaccine is expected to launch in the United States in 2024. Meanwhile, competitors GSK and Pfizer are set to introduce their vaccines during the upcoming fall season.

The efficacy of Pfizer’s vaccine decreased to 78.6% during the second RSV season from 88.9% at the end of the first season among older adults.

Similarly, GSK’s shot showed a decline in efficacy from approximately 94% to 84.6% at the end of the first season.

During a meeting with advisers to the U.S. Centers for Disease Control and Prevention (CDC), GSK disclosed its projected pricing range for its RSV vaccine, estimating it to be between US$200 and US$295 per dose.

Pfizer provided the CDC with a price range of US$180 to US$270 per dose but did not confirm that the final price would fall within that range.

Pfizer cited ongoing negotiations and competition in determining the final pricing for its RSV vaccine.

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