Vaccine cuts for several U.S. states due to FDA confusion

 

• Officials with Operation Warp Speed had to slash the number of COVID-19 vaccine doses for several states in America due to confusion over the FDA's certificate of analysis requirement for vaccine rounds, CNBC reports.
• The federal government’s error disrupted vaccination distribution plans in at least 14 states. Washington state, New Jersey, Virginia, Idaho, Michigan, Connecticut, California, Nevada, Minnesota, Wisconsin, Vermont, Massachusetts, Iowa and Oregon will experience a smaller number doses than expected.
• The agency mistakenly assumed Pfizer’s (NYSE:PFE) vaccine was ready to ship when there was actually a two day lag period in which the FDA requires a certificate of analysis on each set of vaccines, said Dr. Moncef Slaoui, chief advisor of Operation Warp Speed.
• “That lag period has resulted in differences in the plan and what was actually done,” Slaoui said Sunday in an interview to CNN.
• A certificate of analysis is required for each round of vaccine at least 48 hours prior to distribution, but doesn’t require the certificate to be reviewed prior to shipment.
• “The mistake I made is not understanding with exactness — again my responsibility — on all the steps that have to occur to make sure the vaccine is releasable,” Operation Warp Speed Chief Operating Officer Gen. Gustave Perna said at a press briefing.
• U.S. shipped 2.9M doses of COVID-19 vaccines last week, with 2M doses allocated for this coming week's shipment. Officials also plan to send out 5.9M doses of Moderna’s (NASDAQ:MRNA) vaccine this week.
• https://seekingalpha.com/news/3646046-vaccine-cuts-for-several-u-s-states-due-to-fda-confusion