US cut number of vaccines sent to some states due to confusion over FDA rule

The U.S. government had to cut the number of doses of Pfizer's COVID-19 vaccine sent to several states because of confusion over an FDA rule, CNBC reported. 

The confusion disrupted vaccine distribution plans in at least 14 states and governors said they were caught off guard when their states received less vaccine doses than promised. 

Moncef Slaoui, PhD, head of Operation Warp Speed, the government's initiative to speed COVID-19 vaccine and drug development, told reporters Dec. 20 that the government mistakenly assumed Pfizer's vaccine was ready to ship, but an FDA rule actually required a two-day lag period to receive a certificate of analysis on each set of vaccines, CNBC reported. The certificate includes quality control test results, which is part of Pfizer's emergency use authorization. 

Operation Warp Speed COO U.S. Army Gen. Gustave Perna repeatedly apologized for the error Dec. 19, according to CNBC

"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," he said at a press briefing. 

States that received a smaller number of doses than expected include Washington state, New Jersey, Virginia, Idaho, Michigan, Connecticut, California, Nevada, Minnesota, Wisconsin, Vermont, Massachusetts, Iowa and Oregon.

Washington Gov. Jay Inslee said his state received 40 percent less vaccine doses than expected, according to CNBC

A Pfizer spokesperson told CNBC the drugmaker still expects to deliver up to 50 million doses globally this year. 

Read the full article here.

 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars