“This leaked contract teaches the world more about how to make mRNA vaccines than anything done by rich countries so far.”
September 15, 2021
While combing through a leaked contract published earlier this year by an Italian broadcaster, the U.S.-based consumer advocacy group Public Citizen identified a component of Pfizer-BioNTech’s secretive coronavirus vaccine recipe—a discovery that could help manufacturers around the world replicate the lifesaving shot.
“This info can help mRNA vaccine scientists by illustrating the kinds of requirements
they need to meet critical quality standards.”
—Zain Rizvi, Public Citizen
The document (pdf) analyzed by Public Citizen is an agreement that the European Commission reached with Pfizer and BioNTech last November to purchase 100 million doses of the companies’ mRNA vaccine, which was developed with the support of government funding and U.S. taxpayer-financed technology.
In the 104-page contract, Public Citizen found a list of manufacturing specifications for the Pfizer-BioNTech vaccine, including particular composition and strength, identity, and purity requirements followed throughout the production process.
“This info can help mRNA vaccine scientists by illustrating the kinds of requirements they need to meet critical quality standards,” said Zain Rizvi, a law and policy researcher at Public Citizen who authored the group’s analysis of the contract.
Rizvi pointed out that the World Health Organization (WHO) is currently “trying to teach developing countries how to make mRNA vaccines and could desperately use help.”
“This leaked contract teaches the world more about how to make mRNA vaccines than anything done by rich countries so far,” he argued.
Public Citizen emphasized in its analysis Wednesday that the manufacturing details laid out in the contract represent “just a small fraction of the information about Covid vaccines that rich countries currently possess.”
The group explained:
As part of the regulatory process, manufacturers submit chemistry, manufacturing, and controls (CMC) data. This contains the vaccine recipe. In addition to specifications, it includes information about chemical characteristics; methods of manufacture, including raw material sources; flow charts of the manufacturing process, complete with a list of all tests performed at each step; process controls; drug substance batch records; and drug product master production records. In the U.S., the Biomedical Advanced Research and Development Authority and the Department of Defense have access to this information under vaccine development contracts
In exchange for reasonable compensation to originator corporations, governments should release the information they hold.
Speaking to the Washington Post on Wednesday, Rizvi specifically called on the Biden administration to “help the world produce more vaccines by sharing the rest of the vaccine recipe.”
Despite pressure to do so from public health advocates and a leading National Institutes of Health scientist who helped develop key vaccine technology, the Biden administration has thus far declined to compel pharmaceutical giants to share their recipes and technological know-how with low-income countries.
“The longer vaccine inequity persists, the more the virus will keep circulating and changing.”
—Dr. Tedros Adhanom Ghebreyesus, World Health Organization
The global humanitarian group Doctors Without Borders—known internationally as Médecins Sans Frontières (MSF)—estimates that at least seven manufacturers on the African continent “currently meet the prerequisites to produce mRNA vaccines, if all necessary technology and training were openly shared.”
But Pfizer and Moderna, the makers of the two available mRNA vaccines, have refused to voluntarily participate in technology-sharing efforts facilitated by the WHO, leaving developing countries largely without access to the shots. Just 2% of the more than 5.7 billion total coronavirus vaccine doses administered thus far have gone to people in Africa, according to WHO Director-General Tedros Adhanom Ghebreyesus.
“This doesn’t only hurt the people of Africa, it hurts all of us,” Tedros said in a statement Tuesday. “The longer vaccine inequity persists, the more the virus will keep circulating and changing, the longer the social and economic disruption will continue, and the higher the chances that more variants will emerge that render vaccines less effective.”
As Reuters reported earlier this week, ongoing “efforts to develop an African base for Covid-19 vaccine production will focus on trying to replicate Moderna’s shot, but a lack of progress in talks with the U.S. company mean the project will take time.”
“Moderna said last October it would not enforce patents related to its shot during the pandemic, raising hopes that other companies might be able to copy it and help boost Covid-19 vaccine production,” Reuters noted. “In practice, though, it is hard to replicate a vaccine without the information on how it is made, and the World Health Organization-backed tech transfer hub in South Africa—set up in June to give poorer nations the know-how to produce Covid-19 vaccines—has so far not reached a deal with the company.”
Peter Maybarduk, director of Public Citizen’s Access to Medicines program, said Wednesday that “Pfizer and Moderna endanger the world’s pandemic response by blocking access to the knowledge to make mRNA vaccines.”
“Scientists worldwide, with the right tools and support, could help make many more vaccine doses—but not if basic manufacturing standards are held as corporate secrets,” Maybarduk added.
The pharmaceutical industry has also lobbied aggressively against a patent waiver proposal first introduced at the World Trade Organization last October by India and South Africa. The waiver, which a handful of rich countries are stonewalling, would temporarily suspend intellectual property protections that are barring manufacturers around the world from replicating existing vaccines.
“It’s unconscionable that wealthy governments are reducing lifesaving healthcare to a tradeable commodity and using their power at the WTO to make the right to health subservient to pharma and trade interests,” Aruna Kashyap, associate business and human rights director at Human Rights Watch, said in a statement Tuesday.
In its new analysis, Public Citizen observed that “manufacturers in more than a dozen countries in Africa, Asia, and Latin America have expressed interest in producing mRNA vaccines.”
“Sharing information can help ramp up Covid vaccine production. Sharing information can also advance mRNA science by allowing scientists to quickly learn from each other’s work,” the group said. “Indeed, the development of safe and effective mRNA vaccines builds on decades of scientific discoveries across many different institutions. Secrecy makes us less safe against this virus—and future pandemic threats.”
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