In the past week, President Biden revealed a new plan to share COVID-19 vaccines with other countries, and the CDC allowed vaccination sites to prioritize vaccinations over minimizing waste; both actions reflect the government’s confidence in vaccine supply. Please see details for these and other supply chain developments below:
- On May 17, President Biden announced that, by the end of June, the U.S. will share at least 20 million doses of Pfizer/BioNTech, Moderna, and J&J vaccines with other countries. The U.S. will work with COVID-19 Vaccines Global Access (COVAX) and other partners to decide where to send these doses.
- On May 18, the White House COVID-19 Response Team announced a milestone that more than 60 percent of U.S. adults had received at least one vaccine dose.
- On May 19, the FDA issued Guidance: COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention. The guidance focuses on the design, conduct, and statistical considerations of master protocols, which cover multiple substudies within an overall trial structure.
- On May 18, the CDC issued a guidance that health care providers should prioritize the opportunity to vaccinate every eligible person who presents at a vaccination site over efforts to reduce vaccine waste (e.g., puncturing a multidose vial to administer vaccine without having enough people available to receive all doses in the vial).
- On May 19, the FDA authorized undiluted, thawed Pfizer/BioNTech COVID-19 vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month, compared to 5 days previously.
- On May 19, the FDA issued a safety communication to remind the public and health care providers that currently, COVID-19 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19, especially after the person has received a COVID-19 vaccination, because more research is needed for this purpose.
Please do not hesitate to contact us if you have any questions about these developments.