United States: Medical Products Supply Chain Week Review – August 2, 2021
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Last week, the Centers for Disease Control and Prevention (CDC) revised their guidelines for masks for people who have been fully vaccinated. In addition, as the Administration and several health institutions assess the possibility of mandatory vaccinations against COVID-19, several medical associations and other health care groups have issued a joint statement in support of this policy. Please see details of this and other supply chain developments below:
- On July 26, more than 50 affiliated medical associations, companies and healthcare groups released a joint statement of support for mandatory COVID-19 vaccinations for healthcare workers. The groups recognized the possible historical barriers to immunization and proposed solutions to address these issues. Several health facilities 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 US bailout funds to support efforts to increase immunization in underserved communities. The funds will be spent on immunization education, reducing disparities, improving access to vaccines, as well as recruiting and training community health workers.
- On July 27, the CDC revised its mask guidelines to recommend that fully vaccinated people wear masks indoors in areas of “high or high transmission.”
- On July 28, the FDA extended the shelf life of the Janssen (J&J) vaccine to six months, from four months previously allowed. The FDA based this assessment on data from ongoing stability testing at a refrigeration point of 36 to 46 degrees Fahrenheit.
- On July 29, Emergent BioSolutions received a notice from the FDA indicating that its Bayview plant could resume production of the Janssen vaccine. Manufacturing has been on hold since April, when the FDA asked the company to suspend production in light of the results of the facility’s inspection. The April FDA-483 form includes nine observations, citing issues with the facility deviation investigation system, building / equipment design and condition, cross-contamination controls, and employee training.
- On July 29, the president demanded that federal government employees be asked to report their immunization status. For those who refuse to report, masks, social distancing, and weekly or bi-weekly testing will be required. In addition, business travel will not be authorized. The president directs federal agencies to implement similar standards for federal contractors and encourages business to follow the federal model.
Please do not hesitate to contact us if you have any questions about these developments.
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