Pfizer RSV vaccine on track for winter 2025 while Sanofi navigates delays

Pharma News: Pfizer’s respiratory syncytial virus (RSV) vaccine could be included in the National Immunisation Program (NIP) by winter 2025, if the Federal Government “lands a deal” with the pharma company.

The Pharmaceutical Benefits Advisory Committee’s (PBAC) recommendation to fund Abrysvo, a bivalent (RSV A and B) stabilized prefusion F protein subunit vaccine, for preventing lower respiratory tract illness caused by RSV in infants has been widely welcomed. The vaccine is intended for babies from birth through six months via the immunisation of pregnant women.

At the same time, the South Australian Government has taken a proactive step, announcing its intention to offer early access to Sanofi’s monoclonal antibody, Beyfortus (nirsevimab). This option would be available for infants whose mothers cannot be vaccinated against RSV, providing an alternative form of protection.

Federal Health Minister Mark Butler stated, “The Commonwealth is taking a leadership role to negotiate supply and price with Sanofi on behalf of all state and territory governments. But currently, that product has not been subject to a positive recommendation from the PBAC.”

Catherine Hughes AM, Founder and Director of the Immunisation Foundation of Australia, emphasised the urgency of the situation, saying “Australia urgently needs a nationwide RSV immunisation program.

“RSV is the number one cause of hospitalisation of Australian babies, with our littlest ones spending almost 33,000 days in hospital with the virus last year alone,” she said. “RSV is also a leading cause of severe illness and death in older Australians.

Anne Harris, Managing Director for ANZ & Developed Asia at Pfizer, said in a recent interview with Health Industry Hub, “We have an absolute gap in healthcare expenditure being spent on public health and prevention. When you compare us to other advanced economies, we are sitting at 29 out of 36.”

Minister Butler acknowledged that Sanofi’s therapy, Beyfortus, has already been reviewed once before by the PBAC without recommendation. He added, “It’s not uncommon for a sponsor to take an application back to the PBAC with a slightly different case.

“But I can’t imagine, to be blunt about it, that it would all happen in time for winter 2025. Which is why we’re very much focused on the maternal vaccine [Abrysvo] which has been the subject of a positive recommendation from PBAC.”

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