Apart from vaccines, there are now pills to treat COVID-19 and the U.S. government has approved a couple to be used by patients who are at risk of developing complications if they contract the respiratory illness.
The Joe Biden Administration authorized the use of both Paxilovid and Molnupiravir to combat the spread of COVID in the US while the authorization has already been in place in some European countries.
The most interesting part is the fact that these pills could soon be manufactured across the globe which medical experts hope will be a major tool to curb the rise of the pandemic.
Global production of these types of drugs will certainly be a game-changer, especially in poor countries.
However, the effectiveness of these drugs is dependent on how quickly someone starts its usage and that is where quick diagnosis comes in.
For example, Pfizer’s Paxlovid is said to help reduce the risk of hospitalization and even death among high-risk patients by nearly 90% while the one made by Merck and Ridgeback Biotherapeutics called Molnupiravir is said to cut the risk by about 30%.
The US Government has however commenced the purchase of these drugs with Pfizer’s Paxlovid said to cost the government about US$530 per patient – with a few hundreds of thousands of courses being already ordered.
As for Merck’s Molnupiravir, some 3 million courses bought at US$700 each are said to also be ready at the same time frame – early 2022.
The reason COVID-19 pills are quite revolutionary is due to the differences between them and vaccines which are often made by their developers and a few select partners.
These pills on the other hand will be made available for production via generic manufacturers for sale in poor countries across the globe.
That said, it was also revealed that both Pfizer and Merck have signed agreements to share intellectual property for their pills with a UN-backed program known as the Medicines Patent Poll or MPP.
The agreement acts as a middleman that issues production licenses for generic versions of these drugs that will be mass-manufactured and sold in designated low and middle-income countries.
MPP revealed that over 100 applications was received so far for each product from generic manufacturers – but it will offer licenses to select partners before the end of January 2022.
The current head of the Medicines Law & Policy project as well as a former executive director of the MPP Ellen ‘t Hoen has called the deals important agreements that can have a very quick effect.
“It will lead to large-scale, low-cost production of these medicines. That also means that you get larger production of the active pharmaceutical ingredient, which usually has a downward pressure on the price as a whole, so the benefits may be beyond the direct beneficiary countries,” said ’t Hoen, who is part of an MPP advisory body.
According to a report, about 100 low and middle-income countries across the globe will have access to the generic drugs made via the agreements – among them is India, known as the world’s largest producer of generic medicines.
For whatever reason, some populous countries absent from these agreements includes upper-middle-income countries such as Brazil, China, Malaysia, Mexico, Russia, and Turkey.
They are, however, expected to make direct purchases from the drug developers who are expected to offer tiered pricing schemes based on the countries’ ability to afford the drugs.
Experts say this could lead to more limited access in these places unless their governments opt to use flexibilities in intellectual property rules to make or import generic drugs.
“The Pfizer pill is going to be made available to a large number of people with a mild and moderate disease in high-income countries, and you won’t see that happening in upper-middle countries quite so easily,” said Leena Menghaney, global IP adviser for Medecins Sans Frontieres Access Campaign.
MPP and its Generic licensees
Even though the generic production of these COVID-19 pills in low-income countries will be a game-changer, the long-term “millions of people in middle-income countries” that are “hands-off” for generics makers will be left out, according to Menghaney.
There are still in fact questions about how quickly generic drugmakers, like those in India, are able to reproduce their supplies over the next coming months.
Experts believe that maintaining a close relationship with the MPP could help producers streamline their production process.
A good example of this is easing access to samples of the original drug for use in studies required by regulators.
Generic manufacturers working with the MPP will therefore be required to produce the pill and give documented accounts that prove their version works identically to the original.
These drugmakers will also need to submit their product for approval to a stringent regulatory body and then get them registered in any market where they hope to get them sold.
“We hope that this will happen quickly, but it will be well into next year before the products will be available to be procured,” said MPP head of communications Gelise McCullough, noting that the expected drug volume from these producers had yet to be worked out.
Nonetheless, medicines access advocate Achal Prabhala said it was possible generics production in these countries could lead to a situation similar to that seen during the first year of the pandemic with the intravenous treatment Remdesivir.
“[At that time], doctors in hospitals and patients were lunging for it across the world, and in the US and Europe, there was very short supply … whereas it was relatively more easily available in places like India,” said Prabhala, India-based coordinator of the AccessIBSA medicines access project.
Asia-Pacific nations are taking a different approach
The main difference according to references made by Prabhala was that in some poor countries, like India, drug developers such as Gilead had granted licenses to generic manufacturers for production however, western counterparts preferred making direct purchases from the original drug developer.
“It’s understood the monopoly will cause problems in places like India and they do things to mitigate that by providing these licenses and at the same time because there is a monopoly in the rich countries – which are their real markets – that causes a supply shortage,” he said.
Shipments of molnupiravir from Merck are already going out as some generic manufacturers are said to have already come online outside of MPP’s licenses.
In fact, a local pharmaceutical company in Bangladesh is said to have commenced the production of a generic version of the drug.
Rabbur Reza, chief operating officer of Beximco Pharmaceuticals, said his company had already supplied “a number of countries” since launching the generic in November.
The government of Bangladesh has already authorized the use of the drug and Beximco has priced a full course at a maximum of US$21 for its local market – compared to the huge US$700 er course paid by the US government.
“Initially when our R&D team started developing the product, accessing the active material was difficult. However, now we have a smooth flow of … supplies,” Reza said.
This is a sharp contrast to the supply of approved vaccines, which has been starkly uneven between rich and poor countries, despite months of advocates calling for vaccine makers to share technology and support localized production.
As of now, not so many secondary manufacturers are licensed for approval and the drawbacks these companies have is the need for more than just a patent or access to the vaccine in order to reproduce an identical product – unlike the COVID-19 pill in question.
“Making vaccines requires a lot of proprietary know-how and specialized equipment,” said John Donnelly, a principal at Vaccinology Consulting in the US.
“Assuring the quality of vaccines requires strict control of how people behave as they work on the product, because the product is defined by the way it is made, and not just by testing.”
Even though the production of these pills is expected to not face the same limitations as COVID-19 vaccines, some experts on the subject believe that there are other bumps aside from manufacturing that could complicate access to these medicines for parts of the global population.
“The challenge for developing countries will be how they manage the supply and deploy it in the clinic … you wouldn’t want it to become like some antibiotics, where you can get it in the market and people take it indiscriminately,” said Donnelly, noting this could lead to antiviral drug resistance.
Need for a better health services
In order for an effective issuance, there is the need for robust health services that can diagnose eligible people and get them on treatment within five days of symptoms appearing.
“The big question is, will you see governments and companies invest in [these pills], because the health care limitations in countries may limit how meaningful they would be,” said Thomas Bollyky, director of the global health program at the Council on Foreign Relations in New York.
Bollyky added that there was “reason to be sober-minded” in terms of what the pills would mean for the pandemic due to their need to be accompanied by these testing and health services.
“That’s a real problem for a lot of low-resourced settings, where you’re not seeing people early in the process and testing rates have gone down considerably,” he said.
Instead, he stressed the importance of vaccines over pills in such areas. “You don’t want an intervention that needs a lot of health care infrastructure to apply and can only be harnessed once people have got sick.”