Why Pfizer needs time to prepare for COVID-19 treatment

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Pfizer’s new COVID-19 treatment had a hitch when it launched late last year: supplies were limited and the pills can take months to manufacture.

Business leaders say they are ramping up production and expect big gains in the coming months. That could help if another wave of cases develops.

WHAT’S NEW ON SUPPLIES?

The US government distributes Paxlovid, the first tablet authorized to treat the coronavirus. White House coronavirus response coordinator Jeff Zients said Wednesday that the government will have one million courses of treatment available this month. He expects that to more than double in April.

Mike McDermott, director of global sourcing at Pfizer, says there is “sufficient quantity” of Paxlovid available for high-risk patients who need it.

Doctors also have several other treatment options, including a less effective capsule treatment from Merck that US regulators say should only be considered if other options are unavailable or unsuitable.


Dr. Raymund Razonable of the Mayo Clinic said supplies of Paxlovid should increase if another surge materializes, as large as the one caused recently by the omicron variant.

WHY HAS PAXLOVID BEEN MANUFACTURED SO LONG?

The short answer: it’s a complex drug that involves chemical reactions that need time to develop.

Pfizer manufacturing experts liken Paxlovid to a complicated Lego model where key parts are made in different places, then put together and combined.

The initial building blocks can take up to three months to make. Some chemical reactions need several days to develop under controlled temperature and pressure.

“If you put it all together very quickly, it could all go wrong,” said Charlotte Allerton, head of drug design at Pfizer.

These initial building blocks are shipped to another location that manufactures the main part of the drug, the active ingredient. Block off another three months for this process.

Then the ingredient goes to an additional location which pills it and packs the medicine. It can take six weeks. Add another week for quality checks and testing.

Paxlovid’s production involves more than 20 different locations in more than 10 countries.

IS THIS DELAY UNUSUAL?

Pfizer executives say some drugs for other conditions take even longer.

The company said it has already cut Paxlovid’s average production time to about seven months from nearly nine.

The drugmaker is adding more manufacturing and packaging sites. He will try to reduce the production time further, as long as he can do it without affecting the quality.

Merck says it takes about six months to manufacture its treatment, molnupiravir. The company plans to reduce this number to around five over time.

WHY USE SO MANY LOCATIONS?

Pfizer doesn’t have time to build a factory just to make Paxlovid.

Merck also uses 17 factories in eight countries to manufacture molnupiravir.

“If you knew you were going to make this product for 10 years at a given scale, you’d probably build a factory just for that, but otherwise that’s the way we generally do business,” said John McGrath, vice president. at Merck. President.

WHEN DID PFIZER START MAKING PAXLOVID?

The company began preparations in June, about six months before the U.S. Food and Drug Administration cleared the drug. This was also before researchers had completed late-stage studies on its effectiveness.

Pfizer manufactured its first large-scale commercial batch of the active ingredient in September. The company then had to wait for FDA clearance before it could package and label.

The drugmaker spent about $1 billion to get that head start, said Paul Duffy, vice president of Pfizer Global Supply.

WILL SUPPLY IMPROVE?

Yes. McDermott said Pfizer plans to manufacture 30 million patient packs by mid-year and 120 million by the end of 2022.

Outside of those totals, Pfizer lets some generic drugmakers produce Paxlovid under an agreement with the public health organization Medicines Patent Pool. This should boost supply, especially for low-income countries.

President Joe Biden announced Tuesday night that his administration would launch a “test to treat” plan that involves providing free antiviral pills at pharmacies to customers who test positive for the virus.

When asked if Pfizer could handle the additional demands of this program, a spokesperson said the company was “confident in our ability to supply.” He added that the drugmaker remained on track to deliver 10 million treatments to the US government by June.

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AP video reporter Emma H. ​​Tobin contributed to this report.

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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.

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