Pfizer’s Covid-19 vaccine is pictured at Rady Children’s Hospital before being put back in the refrigerator in San Diego, California on December 15, 2020.
Adriana Drehsler | AFP | Getty Images
US officials said Wednesday that they quarantined several thousand doses of Pfizer’s coronavirus vaccine in California and Alabama this week after an “anomaly” in the shipping process caused the storage temperature to drop too low.
Pfizer’s vaccine, which was developed with the German drug manufacturer BioNTech, requires a storage temperature of about minus 70 degrees Celsius. The vials with the vaccine are stored in trays, each containing a minimum of 975 doses, according to the Centers for Disease Control and Prevention.
General Gustave Perna, who oversees logistics for President Donald Trump’s Operation Warp Speed vaccine program, told reporters that two trays of vaccine that arrived at two different locations in California had to be returned to Pfizer after temperatures reached one somehow had fallen to minus 92 degrees Celsius.
The vaccine “never left the truck,” he said at a news conference on Wednesday. “We immediately sent them back to Pfizer and we immediately sent shipments to replace those two trays. We are now working with the FDA, CDC, FDA and Pfizer to determine whether that anomaly is safe or not, but we are not taking any risks and we can see that. “
He said the “anomaly” had happened again in Alabama.
“On the other side of the country in Alabama, two trays were received at one location. The same anomaly went to minus 92. We were able to stop and quarantine the vaccine, stop it and get a replacement shipment to Alabama,” he said.
It is unclear what caused the storage temperature to drop. Pfizer did not immediately return a request for comment.
Americans began receiving some of the first injections of Pfizer’s vaccine on Monday after the Food and Drug Administration approved Pfizer’s vaccine on Friday. Officials and medical experts had already recognized that Pfizer’s vaccine would pose a new logistical challenge as it must be stored at ultra-cold temperatures.
“We’re talking super cold. It’s completely unprecedented,” Soumi Saha, a pharmacist and vice president of advocacy for Premier, a consulting firm that works with thousands of hospitals and nursing homes, told CNBC last month.
She said it was “completely new territory” for health systems. “And so this is a brand new logistical challenge to distribute this vaccine and get it to the right place, while maintaining the integrity of the product,” she said.
During the briefing, Perna said vaccine deliveries in the US remain on track, with 886 more deliveries going to be shipped nationwide on Thursday. The federal government delivered 2.9 million doses of Pfizer’s vaccine this week. Next week, the government plans to ship an additional 2 million doses of Pfizer’s vaccine, as well as 5.9 million doses of Moderna’s vaccine, if approved by the FDA, Perna said.
The FDA’s Vaccines and Related Biological Products Advisory Committee, an outside group of medical experts that advises the agency, will vote Thursday to recommend Moderna’s vaccine for emergencies. A favorable vote from the committee will likely pave the way for Moderna’s vaccine to become the second to be approved for use in the US after Pfizer. FDA approval could come as early as Friday.
“It’s about a steady cadence of deliveries to the American people,” Perna said.