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Pfizer stops Paxlovid trial for standard-risk patients

Pfizer global manufacturing sign at its headquarters in Portage, Michigan.
Paxlovid will be manufactured at Pfizer's headquarters in Portage, Michigan.

Pfizer said a study revealed the treatment was not effective in reducing symptoms in people who don't have health conditions that put them at risk for severe disease.

Clinical tests for Pfizer’s COVID-19 antiviral treatment have hit a snag. The company announced in a news release Tuesday that it would end enrollment in clinical studies for standard-risk patients.

The news comes less than 10-days after Pfizer announced that Paxlovid would be produced in Portage. The company said it would be building new facilities at its Portage complex to handle production. Two hundred and fifty new jobs would also be created.

At the Portage City Council meeting on Tuesday night, acting City Manager Adam Herringa said the decision won’t change the company’s plan to expand operations in Portage.

“They continue to invest in a $125 million dollar expansion as well as 225 jobs,” said Herringa.

Standard-risk patients are people who don’t have health conditions that put them at risk for severe illness. Pfizer decided to stop clinical trials on standard-risk patients because new data showed that Paxlovid isn’t effective for this group. It didn’t reduce the risk of contracting COVID-19 or reduce symptoms; nor did it significantly reduce hospitalizations or deaths.

That’s not the case for other patients. When taken early to treat mild-to-moderate coronavirus, Paxlovid significantly reduces the risk of hospitalization and death in high-risk patients.

The FDA approved emergency use authorization in December for use in high-risk patients over the age of 12. Pfizer is seeking full approval from the FDA for the drug’s use in this group.

Still, it’s a setback for the Kalamazoo County based pharmaceutical firm which hoped to significantly expand sales of the pill to a larger market. 

Pfizer CEO Albert Borla said in the statement, “With up to 40-50% of people around the world estimated to be at high risk, we believe there remains a significant unmet need for treatment options…to help combat this disease, and we will continue to prioritize efforts to advance the development of Paxlovid.”

Pfizer's Mike McDermott said clinical trials will continue for pregnant women, children, and people with compromised immune systems. 

“As we do clinical trials, and as real-world evidence is done, we see the expansion of the product for more and more patients, absolutely,” said McDermott.

John McNeil covers local local government for WMUK. He has over 5 decades of broadcasting experience and over 40 years as a Journalist in Kalamazoo.