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CDC relaxes VFC rules for nirsevimab, COVID-19 immunizations

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Vaccines for Children (VFC) program providers will not be required to keep a private stock of nirsevimab or COVID-19 vaccines during the 2023-’24 respiratory virus season if they are not vaccinating privately insured patients.

Following advocacy efforts by the AAP and others, the Centers for Disease Control and Prevention (CDC) added new addenda to its VFC operations guide Wednesday, allowing flexibility that providers have requested. 

“Fighting respiratory illnesses, such as COVID-19 and respiratory syncytial virus (RSV) infection, is a key public health priority for the Administration and for CDC,” the CDC said in an email to partners. “With the introduction of new vaccines and immunizations—including nirsevimab and updated COVID-19 vaccine—in the VFC program for the 2023-2024 respiratory season, it is more important than ever that CDC build upon the 30-year success of the VFC program so that these new tools are seamlessly integrated into VFC provider practices throughout the U.S.”

Under the new guidelines, VFC providers will have until March 31, 2024 to meet the private stock requirements for COVID-19 vaccines and until Aug. 1, 2024 to meet the private stock requirements for nirsevimab.

The CDC is encouraging providers who do not keep a private stock to help privately insured patients find these products at other locations such as pharmacies and health departments for COVID-19 vaccines. For nirsevimab, providers are encouraged to explore other practices with stock or federally qualified health centers or rural health centers for underinsured patients.

The CDC already had announced it will allow bidirectional borrowing of VFC and private stock for both products in certain circumstances for the 2023-’24 season, although CDC guidance does not supersede jurisdictional policies. Borrowed doses must be repaid dose for dose within one month (or after every five doses for nirsevimab) and administered to the appropriate population. For COVID-19 vaccines, the same vaccine type borrowed must be repaid.

"We appreciate that CDC has documented this flexibility in the VFC operations guide,” said AAP President Sandy L. Chung, M.D., FAAP. “For states with more restrictive borrowing policies, we’d urge their immunization programs to work with pediatricians to adopt the same flexibility. This will help us improve access to immunizations for all children.” 

In addition, VFC awardees may allow certain providers to offer a limited formulary of vaccines. For instance, temporary vaccination clinics and pharmacies could offer just COVID-19 and influenza vaccines and birthing hospitals could offer only nirsevimab and hepatitis B vaccine.

The additional flexibilities come amid supply issues and other logistical hurdles for nirsevimab. Ordering through the VFC program has been put on hold, although it could resume this week with an allocation system targeting awardees who have not yet ordered or who ordered a small amount. In addition, Sanofi is not accepting new orders for the 100-milligram formulation.

For months, the AAP has been in close contact with CDC and manufacturers advocating for measures to reduce barriers to accessing these products and will continue to do so. It recently celebrated the approval of two new Current Procedural Terminology codes related to the administration of nirsevimab, one of which accounts for the work associated with providing counseling.



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