Merck and Pfizer plans to license antiviral pills are a model for improving health equity

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About the Author: Charles gore is the Executive Director of the Medicines Patent Pool.

The emergence of the Omicron variant provides another shocking reminder that this pandemic will not be over anywhere until it is over everywhere. We must seize the opportunity to do what should have been done long ago, which is to relentlessly research all available options to provide globally equal access to essential medicines, diagnostics and vaccines to contain Covid-19 .

Shortly before Omicron’s arrival, there were signs of a willingness to break away from the infuriating mindset that the needs of developing countries should only be met after countries’ demands. rich satisfied.

The two Merck and Pfizer recently announced voluntary licensing agreements with the Medicines Patent Pool to facilitate global access to their new Covid-19 antivirals. The respective sub-licensing deals to generic manufacturers came just days after the companies submitted Phase 3 trial data showing that their oral antiviral drugs (molnupiravir from Merck and Paxlovid from Pfizer, which involves a new compound and existing anti-HIV therapy) were effective in preventing hospitalization and death when given early in an infection. It was an encouraging sign that innovation and global access can be pursued simultaneously.

In addition, in November, the Spanish National Research Council signed an agreement with the MPP to facilitate the rapid manufacture and marketing of its blood test for the detection of anti-SARS-CoV2 antibodies, produced either by vaccination or by infection. The importance of the deal includes the fact that it provides the world’s first non-exclusive license for a Covid-19 health tool. It is also the first license from the World Health Organization’s Covid-19 technology access pool.

The importance of these welcome and transparent agreements should not be overestimated. It will be a while before they translate into affordable Covid-19 drugs and diagnostics in places like Nairobi and Manila. Nonetheless, they provide an opening to address the shortage of Covid-19 vaccines in much of the world – and more broadly, to remove the barriers that have limited access to medical advances in low- and middle-income countries for decades. decades.

About a year ago, several Covid-19 vaccines were at a similar stage of development as new antiviral drugs are now. They were completing phase 3 trials with strong evidence of safety and efficacy. But there was no similar process in place to initiate licensing and technology transfer agreements that could have accelerated access for countries with limited resources. Those deals remain elusive today, even as the MPP began to continue the dialogue on access to vaccines just months after the SARS-CoV2 virus was first identified in China.

It has also been around 18 months since the WHO and a broad coalition of global partners created the Covid-19 Access Tool Accelerator to accelerate the development and production of Covid-19 technologies for low-income countries. and intermediate. Earlier this year, with vaccines still scarce in regions like sub-Saharan Africa, the ACT Accelerator convened a vaccine manufacturing task force to address issues ranging from raw material shortages to restrictions on export and technology transfer agreements that hamper vaccine production in these countries.

The MPP is working with WHO and partners in South Africa to develop an mRNA vaccine technology transfer center. The aim is to provide a comprehensive package (patent licensing agreements and manufacturing know-how) to develop the production capacity of mRNA vaccines in low and middle income countries. This type of alliance is essential to deal with a pandemic which is now approaching the two-year mark. It is also essential for responding to the global health challenges that may arise in the future.

We understand that, compared to producing a pill, facilitating the production of low-cost vaccines requires access to more than just a patent license. There must be agreements to provide generic manufacturers with advice regarding complex technologies and manufacturing processes that are unique to vaccine production. This is especially true when it comes to mastering the relatively new world of mRNA vaccines, such as those developed by Pfizer and Moderna.

But the fundamentals involved in connecting the developers of original products with manufacturers of generics remain the same. And MPP has the expertise, relationships and frameworks in place to address the concerns of vaccine developers and facilitate access to their innovations, just as we have done with drugs over the past 11 years.

The MPP emerged as a result of the harsh experience of health equity that occurred during the HIV / AIDS pandemic, when new life-saving antiretroviral drugs were unavailable or unaffordable in much of the world. Sadly, we are here in the midst of an equally painful crisis involving unequal access to Covid-19 vaccines.

We still have an opportunity to emerge from the Covid-19 pandemic with a model – built on a framework that has effectively increased access to a range of life-saving drugs – to fairly share the fruits of all types of biomedical innovations.

This is the only way to ensure that history does not repeat itself.

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