(Bloomberg Businessweek) -- When Pfizer Inc. revealed the efficacy of its Covid pill last November, the excitement was palpable. Scientists hailed Paxlovid as a breakthrough. World leaders raced to lock up supplies. But just three months into the rollout, optimism about the drug's ability to help bring a swift end to the pandemic is waning, as fears mount that unequal distribution will exacerbate the challenge of getting the virus under control.
It's too soon to say whether this will end up being as inequitable as the botched vaccine deployment. Mass quantities of the therapy may take more than a year to become available because of production and regulatory hurdles, according to drug experts. After wealthy nations snapped up a large share of initial supplies of Paxlovid, which slashed the risk of hospitalization and death from Covid-19 by 89% in clinical trials, many low- and middle-income countries are facing a potentially long wait for generic versions.
“We've already had those discussions with vaccines,” says Borna Nyaoke-Anoke, a doctor and researcher in Kenya with the Drugs for Neglected Diseases Initiative, a nonprofit. “It's quite unfortunate that we need to have them again.”
With thousands of Covid deaths a day, time is the one thing the world doesn't have. Whenever the virus starts to subside, new variants or subvariants pop up, causing fresh spikes in cases. Knowing the critical role Pfizer's drug could play in quashing the virus, health organizations, researchers, and companies are working to accelerate Paxlovid production beyond what is currently forecast and bring down the high cost of manufacturing.
“We need to see what's possible and if we can go faster,” says Janet Ginnard, strategy director at Unitaid, the health agency that's helping to coordinate Covid drug deployment. Unitaid is working with partners exploring how to increase manufacturing yields and helping countries boost testing to get the therapy to more people, she says.
Pfizer in December increased its 2022 production target to 120 million courses from 80 million, after the drug won U.S. regulatory clearance. It's since been approved by authorities in the European Union, the U.K., and elsewhere. The company is approaching more than 100 countries, including low-income nations, to discuss direct supplies. African officials also announced an initial deal with Pfizer in March, and the company is selling as many as 4 million courses as part of an agreement with relief organization Unicef, though health advocates say that's hardly enough, with variants continuing to pose a threat.
The first generic versions of Paxlovid are expected in December at the earliest, says Charles Gore, executive director of the United Nations-backed Medicines Patent Pool. The Geneva-based organization signed agreements with three dozen drugmakers in March so they could supply generic versions of Paxlovid to some 95 countries that are home to almost half of the world's population. The effort to expand supplies is moving as “quickly as humanly possible,” Gore says. “There are a whole bunch of things that have to be done, all of which take time.”
Before making the drug, generic producers need to acquire 38 different ingredients and reagents in large quantities, sourced from suppliers around the globe, according to Airfinity Ltd., a London-based analytics firm. That could lead to bottlenecks.
Manufacturers also face a risk of losing money on their investments amid uncertainties about demand for Paxlovid, says Andrew Hill, a senior fellow at the University of Liverpool in England. Because people are less likely to be hospitalized with the omicron variant, it could become harder for governments to justify purchasing Pfizer's treatment, he says. Still, if a more concerning variant emerges and data show Pfizer's treatment continues to work, “it would be a godsend to have drugs like this,” he says.
The therapy consists of two pills. One, nirmatrelvir, is a new drug designed to block the action of a key enzyme the virus uses to make copies of itself, which is how it infects a person. The other, the HIV medication ritonavir, helps slow the breakdown of the first drug, enabling it to remain active for longer and at higher concentrations. Public information on nirmatrelvir is relatively limited, so producers had to wait for licenses and Pfizer's original product to become available, a spokesperson for the patent pool says.
Merck & Co.'s Covid pill molnupiravir will likely become widely available sooner than Paxlovid. The company signed initial agreements with Indian generic drug companies almost a year ago, then reached an accord to expand global availability in October. Also, producers have more familiarity with the therapy. However, it didn't appear to be as effective as Paxlovid in studies, and it carries risks for some patients.
One key to unlocking the production challenge could come from the Medicines for All Institute at Virginia Commonwealth University. The group, which is working with Pfizer, aims to cut the costs of the initial materials needed to make the drug by 50%, says Frank Gupton, its founder. His team, which identified a way to slash the cost of Merck's therapy by replacing one starting component, is investigating a similar solution for Paxlovid. Pfizer and generic drugmakers would benefit from the breakthrough. “The problem is the supply chain, so we're looking at new and different chemistry” to find less expensive and more readily available materials, Gupton says.
African health officials are acutely aware of what's at stake, with the scramble for Covid drugs. More than two decades before the pandemic, the high price of HIV drugs sparked an outcry as millions in Africa and other regions who couldn't afford the treatments died.
“A global disease became a lower- and middle-income country disease, or an African disease, because we did not have the capacity to be able to have adequate treatment,” says Nyaoke-Anoke, the Kenyan researcher. “The same thing could happen with Covid.”
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