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.
The document analyzed by Public Citizen is an agreement that the European Commission reached an agreement 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 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.”
Truthout Is Preparing to Meet Trump’s Agenda With Resistance at Every Turn
Dear Truthout Community,
If you feel rage, despondency, confusion and deep fear today, you are not alone. We’re feeling it too. We are heartsick. Facing down Trump’s fascist agenda, we are desperately worried about the most vulnerable people among us, including our loved ones and everyone in the Truthout community, and our minds are racing a million miles a minute to try to map out all that needs to be done.
We must give ourselves space to grieve and feel our fear, feel our rage, and keep in the forefront of our mind the stark truth that millions of real human lives are on the line. And simultaneously, we’ve got to get to work, take stock of our resources, and prepare to throw ourselves full force into the movement.
Journalism is a linchpin of that movement. Even as we are reeling, we’re summoning up all the energy we can to face down what’s coming, because we know that one of the sharpest weapons against fascism is publishing the truth.
There are many terrifying planks to the Trump agenda, and we plan to devote ourselves to reporting thoroughly on each one and, crucially, covering the movements resisting them. We also recognize that Trump is a dire threat to journalism itself, and that we must take this seriously from the outset.
Last week, the four of us sat down to have some hard but necessary conversations about Truthout under a Trump presidency. How would we defend our publication from an avalanche of far right lawsuits that seek to bankrupt us? How would we keep our reporters safe if they need to cover outbreaks of political violence, or if they are targeted by authorities? How will we urgently produce the practical analysis, tools and movement coverage that you need right now — breaking through our normal routines to meet a terrifying moment in ways that best serve you?
It will be a tough, scary four years to produce social justice-driven journalism. We need to deliver news, strategy, liberatory ideas, tools and movement-sparking solutions with a force that we never have had to before. And at the same time, we desperately need to protect our ability to do so.
We know this is such a painful moment and donations may understandably be the last thing on your mind. But we must ask for your support, which is needed in a new and urgent way.
We promise we will kick into an even higher gear to give you truthful news that cuts against the disinformation and vitriol and hate and violence. We promise to publish analyses that will serve the needs of the movements we all rely on to survive the next four years, and even build for the future. We promise to be responsive, to recognize you as members of our community with a vital stake and voice in this work.
Please dig deep if you can, but a donation of any amount will be a truly meaningful and tangible action in this cataclysmic historical moment.
We’re with you. Let’s do all we can to move forward together.
With love, rage, and solidarity,
Maya, Negin, Saima, and Ziggy