The Food and Drug Administration has recently granted expanded approval for Moderna’s RSV vaccine, allowing its use in adults aged 18 to 59 who are at high risk of severe illness if they contract respiratory syncytial virus. This marks a significant milestone as the vaccine, previously known as mResvia, was initially only licensed for individuals aged 60 and above.
Moderna’s CEO, Stéphane Bancel, expressed the importance of this approval, stating that RSV poses a serious health risk to adults with certain chronic conditions. The extension of the license to include a younger age group is a crucial step in protecting more individuals from severe illness caused by RSV.
The approval comes amidst challenges faced by Moderna due to skepticism surrounding its messenger RNA vaccine platform, particularly among supporters of health secretary Robert F. Kennedy Jr. The company faced criticism on social media when the FDA approved their second-generation Covid-19 vaccine, mNexspike, with restrictions on eligibility for receiving the vaccine.
Despite these challenges, the path for expanded use of the RSV vaccine has been cleared, with the CDC’s Advisory Committee on Immunization Practices recommending its use in adults aged 50 to 59 with medical conditions that increase their risk from the virus. This recommendation is contingent upon approval from the CDC director or the secretary of the Health and Human Services Department.
However, the fate of this recommendation remains uncertain as Kennedy has not yet signed off on it. Without official approval, health insurers may not cover the cost of the vaccine for individuals in the new age group. Kennedy’s recent decision to replace the entire ACIP with handpicked members has added further complexity to the situation.
In addition to these developments, Moderna recently faced setbacks when HHS canceled grants worth over $760 million for the development of mRNA vaccines to protect against various flu subtypes, citing concerns about safety. Despite these challenges, Moderna plans to make mRESVIA available for both younger adults at increased risk and older adults for the upcoming respiratory virus season.
Overall, the approval of Moderna’s RSV vaccine for a wider age group is a significant advancement in protecting individuals at high risk of severe illness from respiratory syncytial virus. It is essential for public health authorities to work together to ensure the efficient and effective distribution of this vaccine to those who need it most.
