US officials had to return Pfizer vaccine doses after they got too cold

Federal officials had to quarantine and return several thousand doses of Pfizer’s coronavirus vaccine in two different states after they became too cold during the transport process.

Army Gen. Gustave Perna, the CEO of Operation Warp Speed, told reporters Wednesday that an “anomaly” caused two trays at separate locations in California to fall to minus 92 degrees Celsius. 

Pfizer’s vaccine requires a storage temperature of minus 80 degrees Celsius.

Perna said they don’t know how it happened, or what the effect on the vaccines will be.

“We locked those trays down. They never left the truck, and we returned them immediately back to Pfizer and we sent immediate shipments to replace those,” Perna said.

Perna said federal health officials from multiple agencies are working with Pfizer “to determine if that anomaly is safe or not, but we’re taking no chances and we can see that.”

Perna said the “anomaly” also occurred in Alabama.

“We were able to stop and quarantine the vaccine, stop and get a replacement shipment to Alabama,” he said.

According to the Centers for Disease Control and Prevention, each tray carries a minimum of 975 doses each.

Still, Perna said distribution remains on track. The federal government will send states and other jurisdictions an additional 2 million doses of Pfizer’s coronavirus vaccine next week.

If Moderna’s vaccine is authorized by the Food and Drug Administration in the coming days, the administration has allocated nearly 5.9 million doses that will also be delivered next week, with a total of 20 million doses able to be delivered by the end of the month.

The FDA’s Vaccines and Related Biological Products Advisory Committee, an independent group of medical experts, will vote Thursday on whether to recommend FDA grant Moderna’s request for emergency use.

Perna said he expects the Moderna vaccine will be distributed to more rural areas and long term care facilities than Pfizer’s. 

The administration will have more doses available because Moderna was able to scale up manufacturing quickly, and that vaccine doesn’t require ultra-cold storage.

Meanwhile, the Trump administration is continuing negotiations with Pfizer for additional doses by the middle of next year.

Operation Warp Speed chief science adviser Moncef Slaoui said the government is in active talks with Pfizer to secure 100 million additional doses, despite the company warning it won’t be able to deliver more until next summer.

During an interview with CNN’s Sanjay Gupta earlier this week, CEO Albert Bourla said Pfizer is still working out the timeline with the administration. 

Health and Human Services Secretary Alex Azar told reporters the administration is working to help Pfizer maximize manufacturing capacity after the company recently informed the administration about “manufacturing challenges.” 

“We have recently been informed by them finally of various challenges that they might have in their manufacturing and we will ensure that by whatever mechanism, that we provide them full support to ensure that they can produce for the American people,” Azar said.

He did not elaborate on what those challenges were or how they would impact production.

The government has an initial contract for 100 million doses, but declined to exercise an option to expand it to 500 million.

“You know, they’re right now producing at their maximum capacity to deliver on the 100 million, that is in the first tranche of the contract with us,” Azar said.

He added that because Pfizer did not want federal funding to help with the manufacturing and development of its vaccine, the government doesn’t have as much information about the company’s manufacturing capabilities and supply issues.  

“Part of our ongoing discussions is to remediate that and get better visibility into what they’re doing, what challenges they’re facing, because they’ve made significant commitments to us and others,” Azar said, noting Pfizer ended up only able to make half of what it thought they would be able to produce this year.