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Senators Pressure Biden to Release Vaccine Formula

April 21, 2021 by Alexa Hornbeck
Syringes containing the Pfizer-BioNTech COVID-19 vaccine sit in a tray in a vaccination room at St. Joseph Hospital in Orange, Calif., Thursday, Jan. 7, 2021. (AP Photo/Jae C. Hong)

WASHINGTON – A group of senators is urging President Joe Biden to support an international push to make the basic formula for the COVID-19 vaccine available to less affluent countries that are experiencing vaccine shortages.

“Simply put, we must make vaccines, testing, and treatments accessible everywhere if we are going to crush the virus anywhere,” the lawmakers said in a letter delivered to the president last week.

The letter writers, led by Independent Sen. Bernie Sanders of Vermont, have thrown their own support behind an effort championed by India and South Africa and more than 100 World Trade Organization member nations to temporarily suspend certain vaccine-related intellectual property rights.

The proposed patent waiver would enable manufacturers to replicate vaccine formulas that are currently under the exclusive control of large pharmaceutical companies.

“Allowing countries to manufacture locally will expedite access to vaccines and treatment, prevent unnecessary deaths, expedite global vaccination efforts, and facilitate a stronger, faster economic recovery,” the senators wrote.

In addition to Sanders, the letter was signed by Sens. Elizabeth Warren, D-Mass., Tammy Baldwin, D- Wis., Sherrod Brown, D-Ohio, Richard Blumenthal, D-Conn., Ed Markey, D-Mass., Jeff Merkley, D-Ore., Chris Murphy, D-Conn., Chris Van Hollen, D-Md., and Raphael Warnock, D-Ga.

Due to WTO intellectual property rules, countries are barred from producing the current leading approved vaccines, including U.S.-produced Moderna, Pfizer and Johnson & Johnson.

The proposal to temporarily waive the WTO’s intellectual property rules was put forward by South Africa and India in October, and will be a focus at the body’s meeting early next month.

A pharmaceutical industry insider, speaking on background, said one thing that’s often overlooked when people talk about the intellectual property waiver in question is that it would cover all COVID-19 technologies.

“It covers more than just patents,” this individual said. “It covers a broad set of intellectual property, including even copyrights and trademarks … and would extend far beyond vaccines.”

The other claim industry professionals take exception to is that the waiver would enable manufacturers to replicate the vaccines in facilities around the world.

“It’s just more complex than that,” one said.

As an example, they pointed to the mRNA vaccine, which includes components that can only be produced in four facilities in the world at the moment because the production is such a highly specialized and technical process.

“It’s not a simple, or what we call in the industry, a small molecule medicine. It’s a biologic and whole new technology,” this individual continued. “So it’s really important that you have the proper expertise and the proper facilities in place before you start thinking about vaccine production and manufacturing.”

They note that the Pfizer vaccine has 280 different components sourced from 25 suppliers in 19 different countries that are then “assembled” in three manufacturing facilities.

Another argument against an intellectual property waiver being the answer to shortages of vaccine in less affluent parts of the world was highlighted by The Wall Street Journal earlier this week.

Its report found that in many countries, it’s not an actual shortage of vaccines that is the problem, but last-mile distribution issues that are slowing vaccinations. These range from a lack of adequate cold-storage capabilities in local supply chains to communities simply not having enough trained health care workers to administer the shots.

“In many countries, once you get outside the major metropolitian areas, these and other barriers become quite significant,” our industry insider said.

The letter from the senators was just the latest in a series of letters the president has received regarding the issue in recent weeks.

Last Wednesday, for instance, over 60 former heads of state and 100 Nobel Prize winners wrote Biden informing him that they back the effort.

Weeks earlier, more than 400 prominent U.S. health, faith, consumer, labor, development and other organizations wrote Biden, specifically urging him to overturn former President Donald Trump’s block on the waiver. 

Despite widespread support, a handful of countries — the United States, Canada and the United Kingdom, among them, have repeatedly thwarted action on the proposal.

In a news release announcing the circulation of the senators’ letter, Sanders’ office pointed to a recent survey, carried out by Data for Progress and Progressive International, that showed 60% of U.S. voters want Biden to endorse temporarily waiving patent protections on COVID-19 vaccines at the WTO, while only 28% disagreed.

In addition the survey found that 72% of registered Democrats supported such a move, and that even Republicans were on board with 50% of the party’s voters in favor of the temporary waiver and only 36% opposed.

“Your administration has the opportunity to reverse the damage done by the Trump administration to our nation’s global reputation and restore America’s public health leadership on the world stage,” the senators wrote. 

“To bring the pandemic to its quickest end and save the lives of Americans and people around the world, we ask that you prioritize people over pharmaceutical company profits by reversing the Trump position and announcing U.S. support for the WTO TRIPS waiver,” they said.

The Biden administration has taken steps to more fairly distribute vaccines among rich and less affluent countries. In early February, for instance, the White House committed $4 billion to a humanitarian program called COVAX – short for COVID-19 Vaccines Global Access plan.

But experts with a detailed knowledge of the program say the administration is missing the point — COVAX has money; what it doesn’t have is a ready supply of vaccines.

Peter Maybarduk, access to medicines director at the non-profit Public Citizen organization, said while the administration has “done a great job” recommitting the United States to its own COVID response, it should be doing more to end the pandemic globally.

Maybarduk and the representatives of over 60 research organizations have also sent a letter to Biden, urging him to launch a global vaccine manufacturing program which could “solve technical challenges and support humanity in times of great need.” 

“There is a perspective it will be faster to work with large facilities in wealthier countries, but our take is we should do that, and also set up these facilities in other countries,” Maybarduk said. 

In their own letter to President Biden, 31 board members from PhRMA, the trade group representing companies in the pharmaceutical industry in the U.S. said the progress made over the last year in regard to the COVID-19 vaccine has been “nothing short of incredible” and acknowledged that “none of that work would have been possible without the unprecedented collaboration between research-based biopharmaceutical companies, U.S. and global governments, multilateral organizations, nongovernmental institutions and many others.”

The letter continues: “As you and your team know, developing and manufacturing safe and effective vaccines consistently on a global scale is a massive undertaking. COVID-19 vaccines are complex biologic products. The manufacturing requires specialized experience, expertise and equipment. For example, only a few facilities in the world perform some of the critical steps needed to manufacture mRNA vaccines.”

In addition, that said, “Supply chain challenges are being dealt with daily, including in partnership with your administration. As you have seen first-hand, thousands of dedicated American workers at biopharmaceutical manufacturing sites and suppliers throughout the United States are playing a critical role in this effort. … To manage these demands, many of us are working with other manufacturers worldwide with the appropriate expertise, technical capabilities and facilities and have entered into partnerships and licensing agreements to speed up the production and distribution of vaccines.”

On the matter of intellectual property protections, the PhRMA board members said the protections that exist now “have been essential not only to speed the research and development of new treatments and vaccines, but also to facilitate sharing of technology and information to scale up vaccine manufacturing to meet global needs.

“Eliminating those protections would undermine the global response to the pandemic, including ongoing effort to tackle new variants, create confusion that could potentially undermine public confidence in vaccine safety, and create a barrier to information sharing,” they wrote. “Most importantly, eliminating protections would not speed up production.

“The U.S. government has stood alongside other governments—including the European Union, United Kingdom, Japan, Canada, Switzerland, Brazil, and Norway—to oppose this waiver. We urge your administration to maintain this longstanding support for innovation and American jobs by continuing to oppose the TRIPS IP waiver,” the letter continued. “Intellectual property is the foundation for both the development and sharing of new technologies. Perhaps more than any other time in history, society is seeing and benefiting from the innovation supported by intellectual property.

“Despite the immense challenge of scaling manufacturing on novel technologies, current estimates are that COVID-19 vaccine manufacturers will supply approximately 10 billion doses by the end of 2021, enough to vaccinate the entire current global vaccine eligible population,” the writers concluded.

Contacted by The Well News, a spokesperson for PhRMA said “Biopharmaceutical manufacturers share the goal to get the world vaccinated against COVID-19 as quickly as possible and will continue to be a partner in this unprecedented effort.

“It’s important to point out that an intellectual property waiver would not help accelerate COVID-19 vaccine access or address supply chain and logistical constraints. What can continue to help is global collaboration, partnerships and licensing agreements, which vaccine makers will continue pursuing,” the spokesperson said.

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