The Food and Drug Administration recently granted an extension to Moderna’s RSV vaccine, allowing it to be used in adults aged 18 to 59 who are considered at high risk of severe illness from respiratory syncytial virus. Previously, the vaccine, known as mResvia, was only approved for individuals aged 60 and older.
Moderna CEO Stéphane Bancel expressed his satisfaction with the approval, stating that RSV poses a significant health threat to adults with certain chronic conditions, and this new approval is a crucial step in safeguarding more individuals from severe illness caused by RSV.
The approval comes as a relief for Moderna, which has faced challenges due to skepticism surrounding its mRNA vaccine platform, particularly among supporters of health secretary Robert F. Kennedy Jr. There was some backlash on social media when the FDA approved Moderna’s mNexspike, a second-generation Covid-19 vaccine with restrictions on age and health conditions for recipients.
The next phase in expanding the use of the RSV vaccine involves recommendations from the Center for Disease Control and Prevention’s expert vaccines panel, the Advisory Committee on Immunization Practices. The committee previously voted to recommend the use of RSV vaccine in adults aged 50 to 59 with certain medical conditions. This recommendation is awaiting approval from the CDC director or the Health and Human Services Department secretary to take effect.
Despite the potential for expanded usage, concerns have been raised about the cost coverage by health insurers without official recommendations. Additionally, recent developments saw Kennedy dismiss the entire ACIP in an effort to restore public confidence in vaccines, appointing new members to the committee.
In a surprising move, HHS canceled grants worth over $760 million to Moderna for the development of mRNA vaccines, citing safety concerns. Despite this setback, Moderna remains committed to making mRESVIA available for adults aged 18 to 59 and those aged 60 and older for the upcoming respiratory virus season.
Overall, the approval of Moderna’s expanded RSV vaccine marks a significant advancement in protecting high-risk individuals from severe illness caused by respiratory syncytial virus. With ongoing developments and challenges, the company continues to strive towards providing effective solutions for public health concerns.