In the past week, the Suez Canal blockage has shaken the global supply chain. In the U.S., more than 27 million doses of COVID-19 vaccines were distributed, and AstraZeneca responded to concerns over its COVID-19 vaccine trial data. Please see details for these and other supply chain developments below:
- On March 23, a giant container ship ran aground in the Suez Canal, blocking the vital trade route between Asia and Europe. The ship was finally freed on Monday, but the situation has created a global supply chain crisis. While media coverage has been focusing on the impact on industries such as automotive and electronics, the medical product industry should also prepare for likely impact on the supply of raw materials, components, and finished products.
- On March 23, it was reported that the FDA had authorized Catalent’s Bloomington, Indiana, facility to produce Johnson & Johnson’s COVID-19 vaccine and ship out finished doses. Please see Reuters’ reporting here.
- On March 24, AstraZeneca announced that high-level results from the primary analysis of the Phase III trial of its COVID-19 vaccine in the U.S. had confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on March 22. The results were presented to the independent Data Safety Monitoring Board (DSMB) under the National Institutes of Health (NIH). We reported in last week’s review that the DSMB had expressed concerns over the initial data from AstraZeneca.
- On March 24, the FDA revised the blanket emergency use authorization (EUA) of non-NIOSH-approved disposable filtering facepiece respirators (FFRs) for use in health care settings by health care personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak. The revision locked the list of respirators permitted under the EUA to those already authorized.
- On March 26, the White House COVID-19 Response Team announced that in the past week, more than 27 million doses of COVID-19 vaccines were distributed to states, tribes, and territories and through federal channels.
Please do not hesitate to contact us if you have any questions about these developments.