Pfizer’s Covid-19 vaccine is pictured at Rady Children’s Hospital before being returned to the refrigerator on December 15, 2020 in San Diego, California.
Adriana Drehsler | AFP | Getty Images
US officials said Wednesday they quarantined several thousand doses of Pfizer’s coronavirus vaccine in California and Alabama this week after an “anomaly” in the transportation process caused the storage temperature to become too cold.
The Pfizer vaccine, which was developed with the German drug manufacturer BioNTech, requires a storage temperature of around minus 70 degrees Celsius. Vials of the vaccine are kept in bowls, each containing at least 975 doses, according to the Centers for Disease Control and Prevention.
Army General Gustave Perna, who oversees the logistics for President Donald Trump’s Operation Warp Speed vaccination program, told reporters that two trays of the vaccine that arrived at two different locations in California had to be returned to Pfizer after the temperature somehow rose Celsius had fallen minus 92 degrees.
The vaccine “never left the truck,” he said during a press conference on Wednesday. “We immediately returned and mailed them to Pfizer to replace these two trays. We are now working with the FDA, CDC, FDA and Pfizer to determine whether or not this anomaly is safe, but we are not taking any chances one and we can see that. “
He said the “anomaly” had recurred in Alabama.
“Across the country in Alabama, two trays came in at one location. The same anomaly was minus 92. We were able to stop and quarantine the vaccine, pause and get a replacement shipment to Alabama.” he said.
It is unclear why the storage temperature dropped. Pfizer did not immediately return a request for comment.
Americans received some of the first shots of Pfizer’s vaccine on Monday after the Food and Drug Administration approved the vaccine on Friday. Officials and medical experts had already acknowledged that Pfizer’s vaccine would present a new logistical challenge as it would have to be stored in ultra-cold temperatures.
“We’re talking super cold. It’s completely unprecedented,” Soumi Saha, pharmacist and vice president of advocacy at Premier, a consulting firm that works with thousands of hospitals and nursing homes, told CNBC in an interview 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 and do it while maintaining the integrity of the product,” she said.
During the briefing, Perna said that vaccine shipments in the US are still on track. Another 886 deliveries are expected across the nation on Thursday. The federal government released 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 Advisory Panel on Vaccines and Related Biological Products, an external group of medical experts advising the agency, is voting Thursday on whether to recommend Moderna’s emergency vaccine. A positive vote from the committee will likely pave the way for Moderna’s vaccine to become the second approved for use in the US after Pfizer. FDA approval could take place on Friday.
“It’s about a steady cadence of supplies to the American people,” said Perna.