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Pfizer starts RSV trial ahead of winter season

A vaccine against the common respiratory syncytial virus could be available soon, as Pfizer joins GSK and J&J in launching phase 3 trials

For an infection that leads to the death of more than 24,000 older people a year in developed countries and 60,000 children under five each year, respiratory syncytial virus (RSV) has a surprisingly low profile among the general public.

Pharmaceutical companies, however, have their sights firmly set on combating the infection, with several players working on vaccines and antibodies against the virus.

Last week, Pfizer announced the start of a phase 3 trial for its new RSV bivalent prefusion F (RSVpreF) subunit vaccine in adults aged 60 or over. The RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease) phase 3 trial will study the efficacy, immunogenicity and safety of a single dose in 30,000 participants during the upcoming winter season.

RSV is a common and pervasive seasonal respiratory illness that is highly contagious. Infections occur in people of all ages but feels like a common cold for most young adults, but for infants, the immunocompromised, and older adults, it can be life-threatening.

GlaxoSmithKline (GSK) dosed its first patient in a phase 3 trial for its candidate in February; GSK3844766A contains a recombinant subunit pre-fusion RSV antigen (RSVPreF3) combined with a proprietary AS01 adjuvant, which is also used in GSK’s shingles vaccine. In a recent financial update, GSK stated it expected peak sales for the vaccine of $4bn.

Earlier this year, AstraZeneca and Sanofi’s long-acting antibody nirsevimab met the primary endpoint in a late-stage respiratory syncytial virus (RSV) trial in healthy infants.

Janssen also has a phase 3 trial looking at its vaccine candidate, Ad26.RSV.preF.

“RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly-contagious disease,” said Pfizer vaccine R&D head Kathrin Jansen. “The start of this phase 3 study is an important step forward towards our goal of comprehensive immunisation against RSV disease.” She added that the company continued its efforts to protect infants from RSV disease through maternal immunisation.

Harnessing expertise gained from developing vaccines against COVID-19, Moderna has announced it intended to develop a single shot again flu, COVID-19 and RSV, while Pfizer and BioNTech are working in partnership to combine protection from COVID-19 and RSV.

Article by
Hugh Gosling

6th September 2021

From: Research, Regulatory, Healthcare



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