COVID-19 Medical Products Supply Chain Week in Review – June 2021 #3

Alston & Bird

Last week, President Biden announced a new COVID-19 vaccine commitment to the world. In addition, Novavax’s COVID-19 vaccine candidate met the primary endpoint in its Phase 3 trial. Please see details for these and other supply chain developments below:

  • On June 10, President Biden announced that the U.S. will purchase an additional half-billion doses of Pfizer-BioNTech vaccine to donate to nearly 100 low- and lower-middle-income countries. These doses will start to be shipped in August; 200 million will be delivered in 2021, and 300 million more in the first half of 2022.
  • On June 10, Moderna announced that it had requested an FDA emergency use authorization (EUA) for its COVID-19 vaccine in adolescents. 
  • On June 11, the G7 and guest countries (G7+) announced their joint commitment to provide more than 1 billion additional COVID-19 vaccines to the world. In addition, the G7+ committed to increasing investments in local production capacity for COVID-19 vaccines, therapeutics, raw materials, diagnostics, and medical supplies. 
  • On June 11, the FDA announced that it had cleared two batches of the Janssen COVID-19 vaccine drug substance manufactured at the Emergent BioSolutions Baltimore facility as suitable for use. The agency also determined that several other batches were not suitable for use, involving, according to a New York Times article, about 60 million doses. The agency was not ready to authorize the facility for the Janssen vaccine EUA but was reviewing individual batches manufactured there for release. We reported on the Emergent facility’s quality issue with the Janssen vaccine in an earlier issue.
  • On June 14, Novavax announced that its COVID-19 vaccine candidate had met the primary endpoint in its pivotal Phase 3 trial, demonstrating 90% overall efficacy and 100% protection against moderate and severe disease.

[View source.]

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.

© Alston & Bird | Attorney Advertising

Written by:

Alston & Bird

Alston & Bird on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.