Moderna's RSV Vaccine Approval Expanded to High-Risk Adults Under 60

Moderna, a leading company in the mRNA vaccine field, has received approval from U.S. regulators to expand the use of its RSV vaccine to adults under the age of 60 who are at high risk of infection. This decision follows the vaccine's initial approval for individuals aged 60 and above, marking a significant expansion of its eligible population. Moderna's announcement comes as competitors Pfizer and GlaxoSmithKline have also secured approvals for their RSV vaccines targeting different age groups. Pfizer's vaccine is approved for high-risk individuals under 60, while GlaxoSmithKline's vaccine is approved for those aged 50 to 59 who are at high risk. This expansion is expected to increase the accessibility of the RSV vaccine, providing protection to a broader range of individuals who are vulnerable to the virus.

The FDA's decision underscores the growing recognition of the importance of preventing RSV infections, which can lead to severe respiratory illnesses, particularly in high-risk populations. Moderna's vaccine, which has shown efficacy in clinical trials, is now poised to play a crucial role in reducing the burden of RSV-related diseases in the U.S. The company's ability to secure this expanded approval highlights its commitment to developing innovative solutions for public health challenges. This approval is particularly notable given the previous resistance from the Trump administration towards mRNA vaccine technology. The expansion of the eligible population for Moderna's RSV vaccine is a significant step forward in the fight against RSV infections, and it reflects the ongoing efforts to improve public health outcomes through innovative vaccine development.

Moderna's RSV vaccine, mRNA-1345, is based on a single mRNA encoding the pre-fusion F protein, encapsulated in lipid nanoparticles. This mRNA platform allows for rapid updates to the vaccine strain and eliminates the need for protein purification. However, it requires stringent cold chain management and immune response monitoring. In contrast, Pfizer's Abrysvo and GlaxoSmithKline's Arexvy vaccines are based on recombinant proteins with or without adjuvants. Abrysvo contains a bivalent mixture of pre-fusion F proteins from subtypes A and B, while Arexvy contains a single pre-fusion F protein with the AS01E adjuvant. The mRNA vaccine platform offers the advantage of inducing high titers of neutralizing antibodies with a single dose and the ability to quickly iterate the platform. However, mRNA vaccines may have more pronounced local and systemic reactions compared to adjuvanted protein vaccines, which may offer better immune persistence.

This approval comes at a time when the U.S. government, under the leadership of Secretary of Health and Human Services Robert F. Kennedy, has taken a more stringent approach to vaccine approvals and promotions. This includes conducting more clinical research and weakening long-term vaccination recommendations for children and pregnant women. Kennedy has been particularly critical of the mRNA technology that underpins Moderna's vaccines, describing them as "the most deadly vaccine in history." Despite this, Moderna's updated version of the COVID-19 vaccine was recently approved for a narrow range of individuals with at least one severe disease risk factor, and the company's contract for developing an avian flu vaccine was recently terminated by the U.S. Department of Health and Human Services. The department's spokesperson stated that "the fact is, mRNA technology is still not sufficiently tested."

In April, a key advisory committee to the FDA voted to expand the use of RSV vaccines to high-risk adults aged 50 to 59, paving the way for insurance coverage for this age group and signaling the FDA's willingness to approve RSV vaccines for high-risk individuals under 60. This decision is expected to increase the market size for Moderna's mRNA-1345 vaccine, which can induce high titers of neutralizing antibodies with a single dose and quickly iterate the platform to compete with protein vaccines. The expanded approval of Moderna's RSV vaccine is a significant development in the fight against RSV infections and reflects the company's commitment to developing innovative solutions for public health challenges. The decision also highlights the growing recognition of the importance of preventing RSV infections, which can lead to severe respiratory illnesses, particularly in high-risk populations. Moderna's ability to secure this expanded approval underscores its leadership in the mRNA vaccine field and its dedication to improving public health outcomes through innovative vaccine development.