FDA Approves Merck’s Enflonsia

The FDA approved Merck’s Enflonsia (clesrovimab-cfor) which is a monoclonal antibody designed to protect infants against respiratory syncytial virus (RSV) disease. Enflonsia can be given to infants during their first RSV season. Merck’s Enflonsia is similar to Sanofi’s Beyfortus. PCA will begin offering Enflonsia to our members through our Merck program when it becomes available to purchase.

Although Enflonsia is a monoclonal antibody and not a vaccine, we anticipate the ACIP will make recommendations on how Enflonsia should be used. Payer coverage typically occurs within a year after ACIP recommendations are published in the MMWR. We will provide additional information as it becomes available.

To learn more, click here to read Merck’s news release.

FDA Approves Moderna’s new COVID-19 Vaccine mNEXSPIKE

This fall PCA hopes to offer members the opportunity to purchase Moderna’s new COVID-19 vaccine mNEXSPIKE for their patients 65 years and older and high-risk individuals aged 12-64 years. According to Moderna’s press release, this new COVID-19 vaccine “showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older” compared to Spikevax, Moderna’s original COVID-19 vaccine.

Once a new vaccine has been approved by the FDA, it is reviewed by the ACIP. This committee will make recommendations on how this vaccine should be used. Payer coverage typically occurs after ACIP recommendations are published in the MMWR. We will provide additional information as it becomes available.

To learn more, click here to read Moderna’s news release.