Medical Products Supply Chain Week in Review – August 2021 #3

Last week, the FDA amended the Moderna and Pfizer-BioNTech emergency use authorizations (EUAs) to allow an additional dose of the mRNA COVID-19 vaccine for immunocompromised individuals. In addition, the Secretaries of Defense and Veterans Affairs announced an expanded vaccine mandate for their personnel. Also, the CDC recommended that pregnant and breastfeeding women receive the COVID-19 vaccines because they are at a higher risk for severe illness. These developments are expected to drive up supplies of COVID-19 vaccine and related materials. Please see details for these and other supply chain developments below:

  • On August 9, the Secretary of Defense issued a memorandum requiring COVID-19 vaccinations for active duty, reserve, and National Guard servicemembers as of mid-September. If any vaccine receives formal FDA approval before then, the mandate will take effect immediately. 
  • On August 11, the CDC announced that it is recommending COVID-19 vaccination for pregnant and breastfeeding women because pregnant women have an increased risk of severe COVID-19 illness. While the safety and effectiveness data based on clinical trials and adverse outcome review is limited, the data demonstrates that the benefits of vaccination outweigh the potential risks. 
  • On August 12, the Administration’s COVID-19 Response Team provided a status update on the response and current case trends. Vaccination rates continue to rise in low-vaccination states and in the 12-to-17-year-old age group. The Administration continues to support efforts to fight COVID-19 nationally by providing additional personnel and emergency response equipment. 
  • On August 12, the Secretary of the Department of Veterans Affairs announced a vaccine mandate that includes most Veterans Health Administration employees, volunteers, and contractors. Those affected have eight weeks to comply with the mandate. 
  • On August 12, the FDA amended the EUAs for both the Moderna and Pfizer-BioNTech vaccines to allow a third dose for immunocompromised individuals because they do not have the same immune response to the vaccines. The FDA recommended administration of the third dose at least 28 days after the second dose. Following the FDA’s decision to amend these EUAs, the CDC adopted the recommendation of the Advisory Committee on Immunization Practices (ACIP) for the third dose.
  • The FDA’s Center for Devices and Radiological Health (CDRH) published the 2018-2020 Strategic Priorities Accomplishments. By 2020, the FDA sought:
    • 50% of novel technology producers to intend to bring their technology to market in the United States. 62% reported an intent to do so.
    • 80% CDRH employee engagement. 81% of CDRH employees were determined to be engaged in 2020.
    • 80% of the CDRH’s processes to be improved. 86% of processes were improved by the end of 2020.
    • Participation in at least 10 collaborative communities. The FDA was participating in 12 collaborative communities by the end of 2020.

Importantly, the CDRH’s reported metrics on novel technology devices demonstrates a significant interest—beyond the FDA’s target—among manufacturers to bring these types of technologies to the U.S. market. The listed accomplishments also depict an increasingly engaged agency workforce delivering “simplified process operations.” While the CDRH indicates that it is continuing to focus on these strategic priorities through 2021, the center’s performance through the COVID-19 pandemic remains to be seen. 

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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