Medical Products Supply Chain Week in Review – August 2021 #1

Last week, the Centers for Disease Control and Prevention (CDC) revised its mask guidance for fully vaccinated individuals. Also, while the Administration and several health care institutions evaluate the possibility of mandatory COVID-19 vaccinations, several medical associations and other health care groups released a joint statement in support of this policy. Please see details for this and other supply chain developments below:

  • On July 26, over 50 medical associations, societies, and affiliated health care groups released a joint statement of support for mandatory COVID-19 vaccinations for health care workers. The groups recognized possible historical barriers to vaccination and offered solutions to address these issues. Several health care institutions have instituted mandatory vaccinations in response to a spike in new cases. 
  • On July 27, the Department of Health and Human Services (HHS) awarded $121 million in American Rescue Plan funds to support efforts to increase vaccination in underserved communities. The funds will be dedicated to vaccination education, minimizing disparities, increased vaccine access, and recruitment and training community health workers. 
  • On July 27, the CDC revised its mask guidance by recommending that fully vaccinated individuals wear masks indoors in areas “of substantial or high transmission.” 
  • On July 28, the FDA extended the shelf life of the Janssen (J&J) vaccine to six months, up from the previously authorized four months. The FDA based this assessment on data from ongoing stability testing at a refrigeration point of 36–46 degrees Fahrenheit. 
  • On July 29, Emergent BioSolutions received notice from the FDA that its Bayview facility can resume production of the Janssen vaccine. Manufacturing has been on hold since April, when the FDA requested that the company suspend production in light of inspection findings at the facility. The April Form FDA-483 includes nine observations, citing issues with the facility’s deviation investigation system, building/equipment design and condition, cross-contamination controls, and employee training. 
  • On July 29, the President mandated that federal government employees will be asked to report their vaccination status. For those who decline to report, masks, social distancing, and weekly or biweekly testing will be required. In addition, work-related travel will not be permitted. The President is directing federal agencies to implement similar standards for federal contractors and encouraging the business community to follow the federal model. 

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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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