Monday, December 11, 2023

US offers to help increase production of Pfizer / BioNTech Covid vaccine

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The U.S. government is offering to help ramp up production of the Pfizer / BioNTech Covid-19 vaccine, as it attempts to secure an additional 100 million doses of the vaccine that regulators are reviewing.

Operation Warp Speed, the government’s program to speed up vaccine development, is trying to double its pre-order doses, after growing demand has led to a shortage, according to people familiar with the matter.

Operation Warp Speed is trying to help Pfizer obtain more raw materials and equipment under the Defense Production Act to ensure it can produce the extra doses by June 2021, according to one of the people.

Lipid nanoparticles, the fat bubbles that deliver the genetic code into the body, were a particular stumbling block, said two other people familiar with the matter, although an issue with a batch produced in October has been resolved. The ability to fill vaccine vials is also limited, they added.

In July, the United States agreed to pay nearly $ 2 billion for 100 million doses, which would immunize 50 million people, and had the option to purchase an additional 500 million. But the New York Times reported that the Trump administration turned down a second offer in October, before solid data on the vaccine’s effectiveness were released in November.

President Donald Trump said earlier this week that he would use the Defense Production Act if the United States struggles to access enough vaccines, having only used it to boost the manufacture of personal protective equipment.

Production negotiations continue, as U.S. Food and Drug Administration advisers consider whether or not to approve the vaccine, which would be the first to receive emergency use authorization in the United States.

The strategy of Operation Warp Speed ​​was to bet on many horses, in particular by directly financing the vaccines of Moderna and AstraZeneca. Pfizer is part of the program but has chosen not to take funding, just a pre-order that will be paid for when the vaccines are delivered.

Pfizer said, “Recognizing the urgency of the need, our manufacturing teams worked around the clock so that we could bring the vaccine to the world as quickly, efficiently and fairly as possible.”

BioNTech did not comment.

Operation Warp Speed ​​has said the government has contracts with options to purchase “millions of additional vaccines” if approved by the regulator, which it will exercise if and when it chooses.

Pfizer and BioNTech, which say they can manufacture 1.3 billion doses of the vaccine by 2021, have reached agreements to deliver 40 million doses to the UK, 120 million to Japan and 200 million to the EU, with the possibility of ‘buy 100 million more. Manufacturing delays in October, supplies for the last weeks of this year were reduced to a total of 50 million doses.


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