The New York-headquartered drugmaker also plans to expand its Modular Aseptic Processing (MAP) sterile injectable pharmaceutical production facility at Kalamazoo. This expansion adds to the initial investment of $450 million made in phase one, it said.

Paxlovid is recommended for treatment of mild to moderate cases of Covid-19 in patients who are at a higher risk of hospitalization and death. It works by inhibiting multiplication of the virus in combination with ritonavir, a drug used to treat HIV. In clinical trials, the antiviral cocktail showed an 88% risk reduction among adult Covid patients compared to a placebo, if administered within five days of the onset of symptoms.

At the beginning of 2021, both Pfizer and Merck & Co, the latter in collaboration with US biotech Ridgeback Therapeutics, sought the US Food and Drug Administration’s approval for emergency use of their oral antivirals in Covid-19.The Merck product first raised hopes with the company’s claims it could reduce the risk of hospitalization and death by 50% but the efficacy rate was later revised downward to 30% after all trial data had been analyzed.

Pfizer said at the time it aimed to make 80 million courses of Paxlovid up to the end of 2022. This would include the 10 million courses it agreed to provide to the US government for $5.29 billion. The drugmaker said it also planned spend up to $1 billion to support manufacturing and distribution and might outsource some of the work to CDMOs.

In an update, Pfizer said it has now shipped 12 million courses of Paxlovid to 37 countries, including 5 million to US customers and has manufactured almost 17 million treatment courses altogether. The significant investment in API and RSM production for nirmatrelvir, it added, will allow it to increase supply capacity as needed to help meet global demand.

With the risk evaluation officially unchanged, late last month the US Centers for Disease Control (CDC) warned of a potential Covid rebound in patients treated with Paxlovid as early as two-to eight days after completion of a five-day course. However, it said the benefits still “far outweigh” the risks. Among unvaccinated people at high risk for severe disease, the treatment reduced the risk of hospitalization and death by nearly 90%, the health agency said. 

Author: Dede Williams, Freelance Journalist