Pfizer’s adult RSV vaccine approval sets the stage for an imminent launch

In a bid to combat respiratory syncytial virus (RSV) infections in older adults, Pfizer Inc. and GSK Plc have both secured approvals for their respective RSV vaccines. The primary goal of the vaccines is to combat the prevalent respiratory illness that poses a serious risk to older individuals. Pfizer’s vaccine, Abrysvo, gained approval from the U.S. Food and Drug Administration (FDA) for individuals aged 60 and above, matching the target age group of GSK’s vaccine.

Pfizer’s Abrysvo demonstrated promising efficacy in a late-stage study, showing a 67% effectiveness rate against RSV symptoms among adults aged 60 and older with two or more symptoms. Moreover, the vaccine exhibited an 85.7% effectiveness in preventing severe illness characterized by three or more symptoms. Both Pfizer and GSK anticipate a substantial market for RSV vaccines, estimated to be worth billions of dollars.

Pfizer plans to release Abrysvo in the third quarter, anticipating the upcoming RSV season, as long as it receives approval from the U.S. Centers for Disease Control and Prevention (CDC). The CDC’s advisory committee is scheduled to convene in June to discuss the recommended usage and frequency of RSV vaccines, including Pfizer’s and GSK’s offerings.

Pricing details for Pfizer’s vaccine remain undisclosed, with the company emphasizing that it will be value-based to support routine vaccination in the recommended age group. In the event that the CDC endorses the vaccine for regular usage, the majority of senior Americans who are enrolled in the government Medicare health plan can obtain it without incurring any expenses from their own pockets.

RSV typically causes mild symptoms similar to a cold, but it can lead to severe illness and hospitalization, particularly among individuals aged 65 and older. Government data indicates that RSV is responsible for approximately 14,000 annual deaths in this age group in the United States.

In addition to focusing on the elderly population, Pfizer is also pursuing FDA approval for its RSV vaccine with the aim of safeguarding infants through the immunization of pregnant women. If approved, this vaccine would be the first of its kind to safeguard babies, who are at a heightened risk of severe RSV-related complications. The vaccine received support from the FDA’s panel of outside experts for use in pregnant women, paving the way for its launch in the United States and Europe later this year.

In addition to Pfizer and GSK, Moderna Inc. is expected to file for approval of its RSV vaccine for individuals aged 60 and older in the current quarter. Meanwhile, Sanofi and AstraZeneca are awaiting U.S. approval for their preventive antibody, nirsevimab, which targets RSV in newborns and infants. In Europe, nirsevimab has already gained marketing authorization under the name Beyfortus.

The RSV vaccine market is emerging as a significant battleground within the pharmaceutical industry, with analysts projecting a potential opportunity exceeding $10 billion. With positive phase 3 vaccine results from Pfizer, GSK, and Moderna, and the upcoming potential approval of Sanofi and AstraZeneca’s antibody, the race to provide effective protection against RSV is intensifying.

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