Some vaccine doses stay too cold, Pfizer has manufacturing problems, US officials say.



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(Reuters) – The first days of Pfizer Inc’s COVID-19 vaccine launch have seen unexpected issues including some vaccines stored in excessively cold temperatures and Pfizer reporting potential challenges in its vaccine production, US officials said in a press call. on Wednesday.

At least two COVID-19 vaccine dose trays delivered in California were due to be replaced after storage temperatures fell below minus 80 degrees Celsius (minus 112 degrees Fahrenheit), said U.S. Army Gen. Gustave Perna In the call. Pfizer vaccines, made with partner BioNTech SE, are supposed to stay around -70 ° C.

Officials are investigating whether storing the vaccines in excessively cold temperatures poses a safety or efficacy risk, he said.

Pfizer has also reported some production problems, said US Secretary of Health and Human Services Alex Azar.

“We will ensure that, by whatever means, we provide them with full support to ensure that they can produce for the American people,” Azar said.

Pfizer did not immediately respond to a request for comment, but its CEO, Albert Bourla, told CNBC earlier this week that the company was asking the US government to use the Defense Production Act to alleviate some ” critical supply constraints “, particularly on some components. He did not provide further details.

Officials did not describe what the specific manufacturing challenges were.

Ugur Sahin, CEO of Pfizer partner BioNTech, told Reuters last week that Pfizer’s initial 2020 production target of 100 million doses was cut in half earlier this year, in part due to problems with the supply of raw materials. He said it has since been settled and manufacturing has started at scale.

Authorities said Wednesday they plan to allocate 2 million doses of the Pfizer vaccine next week and 5.9 million doses from Moderna Inc, assuming it receives regulatory clearance. Moderna’s vaccine is likely to be licensed on Friday, they said.

The US government is in talks with Pfizer to secure an additional 100 million doses, Dr. Moncef Slaoui, chief adviser to US Operation Warp Speed, said in the call. It had previously contracted with Pfizer the option to purchase up to an additional 500 million doses at an unspecified price.

Authorities said Wednesday that the United States has already contracted 300 million doses of vaccines between the injection of Pfizer / BioNTech and one of Moderna in the first half of next year, and 900 million doses in total from drug manufacturers developing vaccines. COVID-19.

Officials said logistics companies United Parcel Services Inc and FedEx Corp are developing contingency plans for vaccine deliveries this week in response to forecasts of heavy snow storms in parts of the United States.

(Reporting by Carl O’Donnell and Rebecca Spalding in New York and Manas Mishra in Bengaluru; Edited by Bill Berkrot and Lisa Shumaker)



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