COVID-19 Medical Products Supply Chain Week in Review – February 2021 #4

Alston & Bird

In the past week, the Biden Administration further increased COVID-19 vaccine supply, but the severe winter weather caused widespread delays in vaccine shipments and deliveries. In addition, the Administration announced its plan to invest in domestic manufacturing of testing supplies. Please see details for these and other supply chain developments below:

  • On February 16, the White House announced that the Administration will increase weekly vaccine supply to states, tribes, and territories to 13.5 million and double the weekly vaccine supply to local pharmacies from 1 million to 2 million doses.
  • On February 16, a CDC spokesperson revealed that the U.S. government was projecting widespread delays in COVID-19 vaccine shipments and deliveries due to the recent severe winter weather. As of February 19, shipment delays had been reported in California, Colorado, Florida, Illinois, Nevada, New Jersey, Ohio, Utah, Washington, and Oregon, among other states, forcing vaccine sites to temporarily close and appointments to be rescheduled. See the New York Times reporting here
  • On February 17, President Biden announced that HHS and the DOD will invest $815 million to increase domestic manufacturing of testing supplies and raw materials that have seen shortages, including filter pipette tips, nitrocellulose used in antigen point-of-care tests, and specific injected molded plastics needed to house testing reagents.
  • On February 18, President Biden announced that the U.S. will provide an initial $2 billion contribution to Gavi, the vaccine alliance that co-leads COVAX, a global initiative aimed at equitable access to COVID-19 vaccines. The U.S. will also take a leadership role in galvanizing further global contributions to COVAX by releasing an additional $2 billion through 2021 and 2022; the first $500 million will be made available when existing donor pledges are fulfilled and initial doses are delivered to AMC countries. The President also called on G7 and other partners to support Gavi.
  • On February 19, Pfizer and BioNTech announced the submission of new data to the FDA demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators. The data have been submitted to the FDA to support a proposed update to the U.S. Emergency Use Authorization (EUA) Prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low-temperature freezer. Further, new data shows that the Pfizer vaccine generates robust immunity after one dose, providing strong arguments in favor of delaying the second dose of the two-shot vaccine. See the Wall Street Journal reporting here.

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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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