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

Last week, six U.S. agencies updated an advisory to urge businesses to conduct human rights due diligence for supply chain links to Xinjiang, China. In addition, the Pfizer/BioNTech COVID-19 vaccine received Priority Review designation from the FDA. Please see details for this and other supply chain developments below:

  • On July 13, the Department of State and five other agencies issued an updated Advisory: Risks and Considerations for Businesses and Individuals with Exposure to Entities Engaged in Forced Labor and Other Human Rights Abuses Linked to Xinjiang, China, urging businesses to conduct supply chain due diligence to avoid potential reputational, legal, and economic consequences of involvement with entities or individuals associated with human rights abuses in the region. 
  • On July 13, the FDA announced revisions to the fact sheets for the J&J (Janssen) COVID-19 vaccine, focusing on an observed increase in risk of Guillain-Barré Syndrome (GBS)—a potentially serious neurological disorder—following vaccination.
  • On July 13, the FDA authorized the use of an additional batch of vaccine drug substance from the Emergent facility under the EUA for the Janssen COVID-19 vaccine. The agency stated that it was not yet ready to include the Emergent facility in the Janssen EUA as an authorized manufacturing facility.
  • On July 16, Pfizer and BioNTech announced that the FDA granted Priority Review designation to the Biologics License Application (BLA) for their COVID-19 vaccine for individuals 16 years old and older. The statutory goal date for the agency’s decision is in January 2022. 
  • On July 16, the White House COVID-19 Response Team commented that the U.S. is seeing “a pandemic of the unvaccinated” and urged more people to seek vaccination. The team also stated that the U.S. has secured enough vaccine supply for booster shots if needed.

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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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