COVID-19 Medical Products Supply Chain Week in Review – July 2021 #1

Last week, the White House released a framework for U.S. leadership in the global COVID-19 response. In addition, the FDA is revoking the emergency use authorizations (EUAs) of all non-NIOSH-approved disposable respirators and decontamination and bioburden reduction systems. Please see details for these and other supply chain developments below:

  • On June 29, the U.S. and Taiwan held the eleventh Trade and Investment Framework Agreement (TIFA) Council meeting. Notably, during the meeting, the U.S. recognized Taiwan’s progress in enforcement of trade secrets protections and upcoming changes to Taiwan’s medical device approval process.
  • On June 30, the FDA announced its plan to revoke the EUAs of all disposable respirators that are not approved by the National Institute for Occupational Safety and Health (NIOSH) and the EUAs of decontamination and bioburden reduction systems for personal protective equipment. This policy change was due to the increase in domestically manufactured NIOSH-approved N95s available throughout the U.S.
  • On July 1, the White House COVID-19 Response Team stated that there was direct data showing the effectiveness of the AstraZeneca and the mRNA vaccines against the SARS-CoV-2 Delta variant and indirect evidence for effectiveness of the J&J COVID-19 vaccine against the new variant.
  • On July 1, the White House released the U.S. COVID-19 Global Response and Recovery Framework, including five key objectives:
  1. Accelerate widespread and equitable access to and delivery of safe and effective COVID-19 vaccinations.
  2. Reduce morbidity and mortality from COVID-19, mitigate transmission, and strengthen health systems, including to prevent, detect, and respond to pandemic threats.
  3. Address acute needs driven by COVID-19, mitigate household shocks, and build resilience.
  4. Bolster economies and other critical systems under stress due to COVID-19 to prevent backsliding and enable recovery.
  5. Strengthen the international health security architecture to prevent, detect, and respond to pandemic threats.
  • On July 2, the FDA authorized the use of another batch of J&J (Janssen) COVID-19 vaccine drug substance manufactured at the Emergent facility. The agency stated that it was not yet ready to include the Emergent facility in the Janssen EUA as an authorized manufacturing facility.

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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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