Medical Products Supply Chain Week in Review April 26, 2021

COVID-19 Medical Products Supply Chain Week in Review – April 26, 2021

In the past week, President Biden announced that the U.S. had reached a new vaccination milestone. Also, the FDA and CDC decided to resume the use of Johnson & Johnson’s vaccine, and the FDA finished its inspection of the Emergent Baltimore site with nine observations. Please see details for these and other supply chain developments below:

  • On April 20, the FDA issued an amendment allowing certain molecular COVID-19 diagnostic tests under an emergency use authorization (EUA) to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals as part of a serial testing program after developers submit a complete notification, including meeting required validation data, as set forth in the amendment letter.
  • On April 21, the FDA announced that it had completed its inspection of J&J’s Emergent vaccine contract manufacturing site in Baltimore and posted the Form FDA-483 with nine observations. We reported on the inspection in our previous issue
  • On April 21, President Biden announced exceeding 200 million COVID-19 vaccine shots in the first 92 days of his Administration and that all Americans over the age of 16 would be eligible to be vaccinated on the same day of the announcement.
  • On April 23, following the second meeting of the Advisory Committee on Immunization Practices (ACIP) to discuss the J&J vaccine’s blood clot cases, the FDA and CDC determined that the recommended pause on the use of the J&J vaccine should be lifted. We reported the recommended pause in the use of the vaccine in our previous issue.
  • On April 25, the U.S. government announced that it is making certain urgently needed COVID-19 medical products and raw materials, including vaccine raw materials, available to India in response to the recent spike in COVID-19 cases there. The U.S. had applied the Defense Production Act to put export restrictions on various COVID-19 medical products and raw materials in the early days of the pandemic. 

Please do not hesitate to contact us if you have any questions about these developments.

Media Contact
Alex Wolfe
Communications Director

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