CDC immunization advisors vote to reduce recommendations for RSV vaccination

The current and future landscape of respiratory syncytial virus (RSV) vaccination is evolving fast and is exemplified by Moderna’s mRESVIA. However, there is evidence that points to a decline in demand for these vaccines, implying that the market may be shrinking. The first update refers to the fact that CDC’s Advisory Committee on Immunization Practices has changed the recommendations on RSV vaccination – focusing on a more limited population.
During a recent meeting the ACIP reached a unanimous decision to recommend a single lifetime dose of the RSV vaccine for individuals more than 75 years of age and for any individual between 60 and 74 years of age with higher risk for severe disease. This change comes in contrast with the earlier recommendation stating that anyone above 60 years of age should be given the vaccine as discussed with their physicians. The enhancement of the guidelines now entails that anyone from the age of 75 and above are advised to take the RSV shot even without an evaluation. Nonetheless, the increased-risk restriction for people between 60 and 74 years is a significant blow to the vaccine creators.

The changes to the advice were due to a new possible connection between RSV vaccines and the nerve disorder GBS (Guillain-Barré syndrome). Health officials conducted an initial statistical survey earlier in the year, and recognized 23 GBS patients out of roughly 9.5M older individuals who were immunized with RSV vaccines. This possible correlation is still inconclusive. Despite this, GSK has promised to undertake a strict epidemiological trial to determine the possibility of the correlation.
After the ACIP vote, all the share prices of the three leading manufacturers of RSV vaccines, including GSK, Pfizer, and Moderna, dropped. GSK’s shares were down by over 3 percent, Pfizer’s by over 2, while Moderna dropped 11% by close of market on Wednesday. Arexvy by GSK was the first to be approved last year and it remained the market leader accounting for over 65% of the market. The company achieved £182M ($227M) of sales in Q1 this year. Pfizer’s Abrysvo also did good business making $145M in quarterly sales.

The market opportunity for Moderna was achieved through the assessment of the company in the ACIP meeting. As per GSK’s regional manager Luke Miels, the decision would set off what he referred to as the ‘contract-scamper,’ ahead of the next RSV season that commences in the fall. Despite the ACIP not having access to Moderna’s real-life data, the longer-term data that the company has laid out envisages a difficult path forward. After 18.8 months of follow-up, the efficacy of the mRESVIA vaccine has been at 50%, while in a phase 3 trial the efficacy rate was observed to be at 81% after 3.7 months. On the other hand, efficacy for Abrysvo was 78% at 16.4 months, and 68% for Abrysvo after 23 months.
Based on the Evercore ISI analysts, Arexvy shows the most promising results among all the vaccines in the group, which will ensure GSK to retain the majority of sales. However, GSK does not have the pegged influence over its proxies that the article depicts. The United Kingdom’s government has recently selected the Pfizer company to offer them 5 million doses of Abrysvo in the next two years.

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