In the past week, the Biden Administration further increased COVID-19 vaccine supply and signed contracts with Pfizer and Moderna for 200 million more doses, putting the Administration on track to have enough supply for 300 million Americans by the end of July. Meanwhile, the FDA issued an Emergency Use Authorization (EUA) for Eli Lilly’s treatment of mild to moderate COVID-19. Please see details for these and other supply chain developments below:
- On February 9, the White House’s COVID-19 Response Team announced that the Administration will increase weekly vaccine supply to states, tribes, and territories to 11 million, a 5 percent increase over the previous week.
- On February 9, the FDA issued an EUA for Eli Lilly’s antibody combo, bamlanivimab and etesevimab, for the treatment of mild to moderate COVID-19 in adults and pediatric patients.
- On February 11, the FDA re-issued Guidance: Investigational COVID-19 Convalescent Plasma to replace the January 2021 version. The revisions address when individuals who have received an investigational COVID-19 monoclonal antibody therapy as a participant in a clinical trial, or received an authorized or licensed COVID-19 monoclonal antibody therapy, qualify as convalescent plasma donors. The new version also notes that the FDA intends to exercise enforcement discretion over the investigational new drug requirements for use of convalescent plasma including when, among other circumstances, the donor meets the qualifications for individuals who have received a COVID-19 vaccine or COVID-19 monoclonal antibody therapy.
- On February 11, President Biden announced in Remarks to National Institutes of Health Staff that the Administration signed contracts with Pfizer and Moderna for 200 million more doses of vaccines. Both companies agreed to expedite delivery of 100 million doses for arrival by the end of May, instead of the end of June as previously committed. The contracts put the Administration on track to have enough vaccine doses for 300 million Americans by the end of July.
- On February 23, the House Oversight and Investigations Subcommittee will hold a hearing for COVID-19 vaccine manufacturers’ executives to provide updates on their companies’ efforts to develop and scale up production of the vaccines. Officials from AstraZeneca, Johnson & Johnson, Moderna, Novavax, and Pfizer have been invited to testify.
Please do not hesitate to contact us if you have any questions about these developments.