Some doses of vaccine kept too cold, Pfizer with manufacturing issues, U.S. officials say

(Reuters) – The first days of Pfizer Inc ‘s COVID – 19 vaccine release saw unexpected blows involving some vaccines being stored at too cold temperatures as Pfizer reports on potential challenges the vaccine production, U.S. officials said on a news call Wednesday.

At least two batches of COVID-19 vaccine doses delivered in California had to be replaced after their storage temperature dropped below minus 80 Celsius (minus 112 Fahrenheit), U.S. Army General Gustave said Perna on the call. Pfizer vaccines, manufactured by partner BioNTech SE, are expected to remain at around 70C.

Officials are investigating whether storing the vaccines at too cold a temperature poses a safety or efficacy threat, he said.

Pfizer has also reported some production issues, said U.S. Secretary of Health and Human Services Alex Azar.

“We will make sure that, whatever the approach, we will fully support them to ensure that they can bring fruit to the American people,” Azar said.

Pfizer did not immediately respond to a request for comment, but CEO Albert Bourla told CNBC earlier in the week that the company was urging the U.S. government to use the Defense Production Act to alleviate some of the “restrictions emergency provision, ”particularly in some components. He gave no further details.

Officials did not explain the specific manufacturing challenges.

Ufur Sahin, chief executive of Pfizer partner BioNTech, told Reuters last week that Pfizer ‘s original production target of 100 million doses had been cut in half earlier this year in part on supply issues. raw materials. He said that has been resolved and manufacturing has begun at scale.

Officials said Wednesday that they plan to dispense 2 million doses of the Pfizer vaccine next week and 5.9 million doses of Moderna Inc, assuming it receives regulatory approval. The Moderna vaccine is likely to be approved as soon as Friday, they said.

The U.S. government is in talks with Pfizer to get an additional 100 million doses, said U.S. Operational Warp Speed ​​Chief Adviser Dr. Moncef Slaoui said on the call. They had previously contracted with Pfizer for the option to purchase up to 500 million additional doses at an unspecified price.

Officials said Wednesday that the United States has already contracted 300 million doses of vaccine between the Pfizer / BioNTech picture and one from Moderna in the first half of next year, and a total of 900 million doses from drug sales improve COVID-19 vaccines.

Officials said logistics companies United Parcel Services Inc and FedEx Corp are developing contingency plans for vaccine delivery this week in response to predictions of severe snowstorms in some parts of the United States.