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November 03, 2021

Senator King Calls on Moderna and Pfizer to Increase Worldwide COVID Vaccine Availability

In face of global threat, Senator asks the manufacturers to allow for generic production of their vaccines to expedite supply, distribution

WASHINGTON, D.C. – U.S. Senator Angus King (I-Maine) today urged Moderna and Pfizer – manufacturers of COVID-19 vaccines – to take the necessary steps to increase vaccine production and expand global availability for their lifesaving products. In a letter to the companies, Senator King stressed the urgency of increasing the global vaccination rate, and asked the manufacturers to license their vaccines to the Medicines Patent Pool (MPP) so that additional vaccines can be produced by qualified generic pharmaceutical firms in other countries, substantially increasing global supply. Senator King’s letter highlights the recent move by another pharmaceutical company, Merck, to provide a royalty-free license for its COVID-19 treatment molnupiravir to the MPP, and urges Moderna and Pfizer to follow suit in order to save lives and bring the pandemic under control globally.

“As COVID-19 continues to threaten our population’s health and stretch economic, health care, and social infrastructure systems in the United States, it remains clear that this is a global health issue. As is the nature of any pandemic, our safety and well-being are not assured until we address the spread of COVID-19 in every country,” Senator King began.

“Only 3.1 percent of people in low-income countries—about 700 million people—have received even one dose of a WHO-listed SARS-CoV2 vaccine, and only 10 percent of the roughly 3.3 billion people in lower-middle income countries are fully vaccinated. We clearly need more of every aspect of the vaccination supply chain, but we critically need to increase the production of vaccines,” Senator King continued, noting that, “I am encouraged to see that a Merck, a major pharmaceutical research and manufacturing company, recently announced it would grant a royalty-free license for a COVID-19 treatment pill to the United Nations-backed Medicines Patent Pool, making molnupiravir available in more than 105 countries.”

“While I understand your preference for in-house production, it appears that there are generic pharmaceutical firms with the technical capacity to measure up to the requirements of your production standards and substantially increase global vaccine availability,” Senator King added.

Senator King closes the letter by laying out three steps to increase global vaccine supply and save lives:

·       License each company’s vaccine and/or pharmaceutical treatment to the Medicines Patent Pool as soon as possible; 

·       Commit to participate in WHO’s South African technology transfer hub and PAHO’s Latin American hubs, to ensure quality protocols in the production of vaccines; and

·       Follow Merck’s lead and commit to a royalty-free license to the MPP for upcoming COVID-19 treatment drugs the companies are currently developing or will develop in the future.

During the COVID-19 pandemic, Senator King has advocated for improved and increased vaccine distribution. Earlier this year, Senator King met with top Biden administration officials and emphasized the need to establish a strong vaccine distribution system, and pressed General Gustave Perna, Chief Operating Officer of Operation Warp Speed, on plans to distribute COVID-19 vaccines to Americans and opportunities to strengthen and streamline the process. Senator King also worked to negotiate the American Rescue Plan, which passed 50-49 in March, and provided critical funding for vaccine distribution efforts.

The full text of the letter is available here and below.

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Dear [Pfizer/Moderna],

As COVID-19 continues to threaten our population’s health and stretch economic, health care, and social infrastructure systems in the United States, it remains clear that this is a global health issue. As is the nature of any pandemic, our safety and well-being are not assured until we address the spread of COVID-19 in every country.

While uptake of COVID-19 vaccines has been robust in the high-income countries of the world, there are still significant regions of the globe—particularly sub-Saharan Africa, but also parts of Latin America, Eastern Europe, and Central Asia—where vaccination has lagged significantly, due at least in part to production constraints. Only 3.1 percent of people in low-income countries—about 700 million people—have received even one dose of a WHO-listed SARS-CoV2 vaccine, and only 10 percent of the roughly 3.3 billion people in lower-middle income countries are fully vaccinated. We clearly need more of every aspect of the vaccination supply chain, but we critically need to increase the production of vaccines.

In this regard, I am encouraged to see that a major pharmaceutical research and manufacturing company, recently announced it would grant a royalty-free license for a COVID-19 treatment pill to the United Nations-backed Medicines Patent Pool, making molnupiravir available in more than 105 countries.

Merck’s molnupiravir can significantly reduce hospitalization and death, and rich nations have moved quickly to secure supplies of the drug for their own populations. According to the New York Times (27 October 2021), the United States’s deal with Merck “fixes the price [of the drug] at $712 per course.” A generic version produced under a royalty-free license could sell for somewhere between $8 and $20 for low- and some middle-income countries. While by no means a perfect solution, Merck’s decision to forego a royalty on molnupiravir is an important one in light of our continuing global crisis. It is my hope that your company might follow a similar path as it continues to manufacture and develop vaccines and treatments for COVID-19.

I appreciate that biologics like vaccines differ from “simple” molecules like antivirals (such as molnupiravir) in that biologics require not just particular chemical ingredients, but also a great degree of tacit and technical knowledge for the construction and growth of the most effective COVID-19 vaccines. I am also aware of your concern that transferring the knowledge and tools for making these vaccines would be extremely challenging because of the newness of this class of vaccines, as well as the need to maintain quality control and assurance.

Even so, our global recovery from the challenges of this pandemic — and more effective response to the next one — provides a strong incentive to work to overcome this challenge. While I understand your preference for in-house production, it appears that there are generic pharmaceutical firms with the technical capacity to measure up to the requirements of your production standards and substantially increase global vaccine availability. As reported in Nature (15 September 2021), the chair of the Medicines Patent Pool notes that the researchers in the pool have vast experience in leading pharmaceutical firms, ensuring best practices, and that the pool “does not give licenses to manufacturers working in a garage.”

Given the urgent need for additional vaccine supply — both to the benefit of our country as well as those still deep in the throes of the pandemic, I urge that your company give serious consideration to taking the following steps:

·       To license your vaccine and/or pharmaceutical treatment to the Medicines Patent Pool as soon as possible;

·       To commit to participate in WHO’s South African technology transfer hub and PAHO’s Latin American hubs, to ensure quality protocols in the production of vaccines; and

·       To follow Merck’s lead and commit to a royalty-free license to the MPP for upcoming COVID-19 treatment drug you may or are developing.

Your company has already made a huge contribution to ameliorating the impacts of the pandemic here at home; I hope you will now consider this approach to sharing those benefits with the rest of the world.

With respect and thanks,

Senator Angus King

  


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