McKesson distributing company notified Michigan state health officials on Tuesday that 11,900 doses of Moderna vaccines were damaged due to exceeding cold temperature limits.
Twenty-one shipments of the vaccine were reported to have their temperature drop below the safety range on Sunday, Jan. 17. The pharmaceutical distributor will investigate the causes.
The frozen vaccines must be kept in temperatures between -13°F and 5°F, the CDC stated (pdf).
“Although it is unfortunate that this vaccine will not be able to be used, we are pleased that the safeguards put into place to ensure the integrity of the vaccine worked. This is the first report of vaccine potentially being compromised during shipment in Michigan and we are working quickly with the distributor to have replacement vaccine shipped out,” said Dr. Joneigh Khaldun, Michigan’s chief medical executive and chief deputy director for health.
Each shipment has a system for monitoring the temperature during transportation. Replacement vaccines were resent on Monday and Tuesday.
“We are committed to accelerating vaccine delivery as we work to reach our goal of vaccinating 70% of Michiganders over age 16 as quickly as possible with the safe and effective COVID-19 vaccine,” added Khaldun.
California Calls for Pause on Use of Batch of Moderna COVID-19 Vaccines
California officials directed COVID-19 vaccine providers on Jan. 17 not to administer any doses from a batch of more than 330,000 Moderna vaccines that were circulated across the state.
The reason was a “higher-than-usual number of possible allergic reactions,” California State Epidemiologist Dr. Erica Pan said in a statement.
Moderna, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) are investigating.
“Fewer than 10 individuals required medical attention over the span of 24 hours. Out of an extreme abundance of caution and also recognizing the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause the administration of vaccines from Moderna Lot 041L20A until the investigation by the CDC, FDA, Moderna and the state is complete,” Pan said.
The possible allergic reactions are believed to have all occurred in people within 30 minutes after being injected. The CDC recommends vaccine providers implement a 15-minute observation period for people getting one of the COVID-19 vaccines, and a 30-minute observation period for people who previously have had an allergic reaction to vaccines or injectable therapies.
Zachary Stieber contributed to this report.