Speaking at the JP Morgan Healthcare Conference, being held virtually this year, on Monday, Pfizer CEO Albert Bourla said the company has plans to boost manufacturing of its COVID-19 treatment Paxlovid by up to 50 percent this year. Bourla said the company would achieve the scale-up by expanding its manufacturing capacity.
Paxlovid was granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) late last month, making it the first authorized antiviral treatment for COVID-19 in the US.
Prior to the authorization, Pfizer had estimated in November that it could make up to 50 million doses of the treatment in 2022, and then later that month, it upped that count to 80 million. And now, Bourla says it can produce 120 million courses of the treatment this year.
A Paxlovid treatment course consists of two pills of the paxlovid (nirmatrelvir [PF-07321332]) protease inhibitor and one of the antiviral ritonavir. Ritonavir is used to treat and manage HIV, and in the Paxlovid treatment, it extends the action of Paxlovid at high concentrations.
“We have confidence that we can make 120 million treatments this year,” Bourla said. “That’s 3.6 billion tablets. That’s a very big capacity. But it is doable.”
At the conference, Bourla also said that an Omicron-targeting vaccine is the “most likely outcome.” In light of this, he said Pfizer is aiming to have a shot against Omicron ready by March.
As Omicron continues to lead to unprecedented increases in COVID-19 cases, the hope is that treatments like Paxlovid can be an added tool in the fight against COVID-19.
Paxlovid treatment was shown to cut the risk of hospitalizations or deaths by 89 percent in a Phase II/III study; final results of the study announced in December confirmed the findings.
Bourla explained the planned manufacturing scheduling for Paxlovid, saying that 6 million to 7 million treatment courses will be produced in the first quarter. This will mean that by the end of the second quarter, the company would have produced 30 million courses. Production of the final 90 million would be divided equally in the last two quarters.
To achieve the scale-up, Pfizer is planning to increase capacity by the end of 2022. Additionally, Bourla explained that several countries have expressed interest in stockpiling Paxlovid, which is possible because unlike vaccines, the treatment pills have a shelf life of three years.
Bourla also said that the manufacturing and scaling up of Paxlovid isn’t as complex as the mRNA COVID-19 vaccines. Although the active ingredient of Paxlovid is difficult to make, the rest of the production process is simpler, he explained.
Producing the vaccines “was highly specialized manufacturing, highly specialized raw materials. Very few places in the world make it,” Bourla said. “Here it is a very different situation. Any decent manufacturer of medicines can make it.”
At the same time, Bourla said Pfizer and partner BioNTech SE are working on two versions of an Omicron targeting vaccine: one an Omicron-specific vaccine and the other a shot that would include the original version of the vaccine and the new Omicron-targeted one. Bourla said Pfizer could be ready to file for U.S. regulatory approval for a redesigned vaccine and launch it as soon as March.
And producing the vaccines won’t be a problem, according to Bourla. This is because Pfizer has built up a lot of manufacturing capacity for the vaccine so switching vaccine recipes won’t be an issue.