Pfizer Leads the RSV Vaccine Race with Abrysvo's Expanded Indication to Adults Aged 18–59

Eastern Time April 9, 2024, Pfizer announced its RSV vaccine under research and development（ Abrysvo）A Phase III clinical study has yielded positive results, indicating that Abrysvo may potentially be used for adults aged 18-59 with lower respiratory tract illnesses caused by the respiratory syncytial virus.（RSV-LRTD）Positive signals.

Image Source: Pfizer Official Website

The data disclosed this time are based on a Phase III multicenter MONeT study, which aims to investigateAbrysvoSafety, Tolerability, and Immunogenicity of Abrysvo in Adults at Risk for RSV-Associated Disease. The study includes Parts A and B. Part A enrolled 681 adult patients aged 18–59 with chronic conditions, receiving a single dose of Abrysvo or placebo; Part B included approximately 200 adults over the age of 18 with compromised immune systems.(including some people over 60 years old), two doses of Abrysvo were used.

According to the official announcement by Pfizer, Abrysvo is awaiting approval and is highly likely to becomeThe world's first RSV vaccine for adults aged 18 and above.

This inevitably brings to mind Abrysvo's counterpart—GSK's Arexvy. The market performance of these two RSV vaccines has consistently been compared in the industry.

On May 3, 2023, GSK's Arexvy was approved by the FDA for marketing, becoming the world's first RSV vaccine. Twenty-eight days later, Pfizer's Abrysvo was also approved by the FDA for marketing. The approval times of the two products were not far apart, but their revenues in the first year showed a significant difference.

According to the annual reports of both companies, GSK's Arexvy revenue in 2023 was $1.55 billion, almost equal to Abrysvo's revenue.(Revenue in 2023 was only $890 million)More than twice as much. The reasons are related to multiple factors such as first-mover advantage and business layout strategy. Pfizer's Chief Financial Officer, David Denton, once publicly expressed that the company was disappointed with Abrysvo’s performance in its first year.

Abrysvo is a potential single product that Pfizer is optimistic about and has high hopes for. In terms of the population covered, Abrysvo is at the forefront of the entire RSV track.

On May 31, 2023, Abrysvo was first approved by the FDA for RSV-LRTD in adults over 60. Three months later, Abrysvo was also approved by the FDA for the prevention of RSV-LRTD in newborns.(By vaccinating pregnant women with a gestational age of 32-36 weeks)By contrast, GSK's Arexvy has only been approved for RSV-LRTD in adults aged 60 and above.

On February 6, 2024, GSK announced that the FDA had accepted the priority review application for Arexvy, which is expected to expand the vaccine's eligible population to adults aged 50-59.

And Pfizer suddenlyThe applicable population will be expanded to adults aged 18 and above.Compared to GSK's previous message, the population range has expanded again.RSAnother breakthrough on the V track.

But whether it is GSK or Pfizer, they can only be considered adult vaccines for now.（Abrysvo Achieving neonatal prevention by vaccinating pregnant women is, strictly speaking, not considered a pediatric vaccine.. AndThe main populations infected with RSV are the elderly and infants. The two vaccines only address the prevention of RSV in the elderly population.

Currently, there is still a significant gap in the clinical availability of RSV vaccines for children, with even higher mortality rates and an urgent need for development.. ButConsidering the particularity of clinical trials in pediatric populations, RSV pediatric vaccines are also more challenging.Conquer。

It is reported that Pfizer has currently launched a clinical trial for evaluation.AbrysvoInPreventive effects in children/adolescents aged 2 to 18.

Besides, it is a pity that neither of the two RSV vaccines mentioned above has been approved in mainland China.However, there has been some good news recently regarding domestically developed RSV vaccines in China.On April 8, 2024, Clover Biopharmaceuticals announced positive Phase I results for its bivalent RSV vaccine SCB-1019.In China's RSV vaccine sector, it is a noteworthy small breakthrough.

2.Clover Announces Positive Preliminary Phase I Results for Bivalent RSV Vaccine Candidate SCB-1019 in Initial Young Adult Cohort | BioSpace

Cover image source: PIXABAY

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