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Teen getting vaccine

HHS releases transition plan for COVID vaccine commercialization

July 12, 2023

Editor’s note: For the latest news on COVID-19, visit

Federal officials are encouraging health care providers to place COVID vaccine orders before regular government ordering ends on Aug. 3.

To prepare for distribution transitioning to the commercial market, the Department of Health and Human Services (HHS) has released a guide with information on ordering, inventory, vaccine disposal and required data reporting. However, many questions remain about vaccine distribution on the commercial market.

Regular government ordering for COVID vaccines and ancillary supplies ends at 4 p.m. EDT Aug. 3. After that time, COVID vaccines will be available via an out-of-cycle request process twice a week.

New monovalent vaccines targeting the SARS-CoV-2 XBB.1.5 strain may be coming this fall and would be the first COVID vaccines distributed by the manufacturers instead of the government. The new vaccines will require authorization by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention (CDC) as to who should get them. Both of those actions are expected in mid to late September. In the meantime, HHS officials encouraged health care providers to maintain their COVID vaccine inventory.

“While many individuals may wait to receive a COVID-19 vaccine until the updated version is released, as it is expected to provide more robust protection against currently circulating variants, certain individuals may need or desire a COVID-19 vaccine prior to the anticipated release of the updated vaccine in the fall,” they wrote in the transition guide.

Once COVID vaccines are available commercially, uninsured children will be able to access them through the Vaccines for Children (VFC) program. Uninsured adults will be able to do so through a temporary program called Bridge Access Program for COVID-19 Vaccines and Treatments.

When the current vaccines expire or are no longer authorized, they should be disposed of as regular medical waste in accordance with local regulations and processes, per the provider agreements. Wastage should be reported to the CDC. More guidance on inventory, administration and disposal reporting requirements will be forthcoming at HHS is encouraging providers to continue to report inventory to after the transition.

The AAP met with White House officials last fall to discuss how to ease the transition to the commercial market, especially since so many children remain unvaccinated. It continues to advocate for smaller minimum orders, single-dose vials, flexible returns, payment for vaccine counseling, flexibility in VFC rules and more.

“Simply put, the nation’s pediatricians need to be supported as we attempt to vaccinate our nation’s youngest citizens against COVID-19,” then-AAP President Moira Szilagyi A. Szilagyi, M.D., Ph.D., FAAP, wrote in a letter to officials last year. “If there are too many financial and practical disincentives for pediatric clinicians to purchase, stock and administer COVID-19 vaccines, we will fail to meet the challenge.”



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