Yahoo Finance CDC Narrows Age Recommendation for Use of RSV Vaccine
On Wednesday, the U.S. Centers for Disease Control and Prevention (CDC) revised their recommendation for the use of respiratory syncytial virus (RSV) vaccines for the upcoming respiratory virus season.
Unlike last year, when the committee members recommended vaccine shots for all individuals aged 60 years and older, this time, the members unanimously voted to recommend that adults aged 75 years and above get an RSV shot. For individuals aged between 60 and 74, the CDC recommended vaccinations only for those at higher risk of severe RSV due to underlying medical conditions.
This recommendation only applies to those adults who did not get vaccinated with an RSV shot last year. Before 2023, there were no approved vaccines against RSV infections anywhere in the world. With the first RSV vaccines available last year, the CDC collected real-world data on how well they worked in people 60 and older. Based on this information, the regulatory body revised its recommendations to prioritize those at the highest risk and ensure the vaccines are used efficiently.
The agency also clarified that it is not recommending RSV vaccines on an annual basis, which is usually the case seen with vaccines for the prevention of other respiratory viruses like COVID-19 and influenza. The regulatory body also stated that the ideal time to get vaccinated is in late summer and early fall before the virus starts spreading more.
This recommendation is a major setback to RSV vaccine makers GSK plc GSK, Moderna MRNA, and Pfizer PFE, as their target market in the United States has now been narrowed down for the upcoming respiratory virus season. Currently, these three companies are the only ones with an FDA-approved RSV vaccine in their portfolio. Post the issue of the CDC recommendation, shares of all three companies dipped slightly on Jun 26.
GSK’s Arexvy and Pfizer’s Abrysvo were the first RSV vaccines that received FDA approval. While GSK generated £1.2 billion (around $1.5 billion) from Arexvy sales in 2023, Pfizer recorded about $890 million from Abrysvo sales during the same period. Concerns remain about whether these vaccine makers will be able to generate the same level of sales in 2024.
The CDC also postponed a vote on recommending the use of the RSV vaccine in adults aged 50-59 at increased risk of disease until the availability of additional data. This was a setback to GSK, whose RSV vaccine received label expansion from the FDA earlier this month for use in this age group. The GSK vaccine is currently the only vaccine approved for use in the 50-59 year age group. Pfizer is in the process of filing a regulatory approval with the FDA seeking label expansion for the use of its RSV vaccine in all adults who are at high risk for RSV disease.
A likely reason for this narrowed recommendation by the CDC could be attributed to the discovery of a potential link between the vaccine shots and Guillain-Barré syndrome (GBS), a rare neurological disorder. Despite the restrictive label, we remain optimistic that the CDC could expand its recommendations over time as more real-world data is accumulated.
The upcoming respiratory virus season will also welcome a new entrant into the RSV vaccine space, Moderna, which secured FDA approval for its mRNA-based RSV vaccine, mResvia, last month.
However, investors have already expressed concerns over the efficacy of Moderna’s RSV vaccine based on the new data presented to the CDC earlier this week. An 18-month analysis of follow-up data showed that Moderna’s RSV vaccine was just about 49.9% effective in preventing RSV-LRTD. This is significantly lower compared with the 80.9% vaccine efficacy achieved by the vaccine at a follow-up period of 3.7 months.
This efficacy rate was also significantly lower compared with GSK’s Arexvy and Pfizer’s Abrysvo, both of which are also approved for similar use by the FDA. These companies also presented data on their respective RSV vaccines to the CDC. Per GSK, a single dose of Arexvy was 78.6% effective in preventing severe RSV-LRTD over two calendar years. Pfizer also reported similar efficacy data, which showed that Abrysvo was 77.8% effective through the second season.
Though study comparisons are difficult, Moderna’s reported data does raise concern over the long-term efficacy of its vaccine compared with those reported by GSK and Pfizer, both of which are currently dominating the RSV vaccine space. Wall Street analysts pointed out that this comparison was not justified since these vaccine makers tested both vaccines in study participants at different points in time.
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