Public Health Advocates Demand Public Ownership of mRNA Manufacturing in US

A coalition of public health advocates is urging the Biden administration to retain public ownership over "any new domestic manufacturing capacity that is established" as a result of the White House's plan to increase the global supply of Covid-19 vaccines, which remain out of reach for billions of impoverished people worldwide due to dose hoarding by rich countries and knowledge hoarding by Big Pharma.

"Publicly financed vaccine production should be publicly controlled."

"Unless the U.S. government owns the manufacturing and exercises stewardship of the mRNA vaccine technology it helped pioneer, we risk repeating the cycle of the past year, in which manufacturer failures and corporate control compromise global vaccine access and slow efforts to end the pandemic," Partners In Health, PrEP4All, and Public Citizen wrote Monday in a letter. "We call for domestic mRNA production to be publicly owned."

The letter--addressed to David Kessler, the White House's chief scientific officer for the country's Covid-19 Response, and Gary Disbrow, director of the Biomedical Advanced Research and Development Authority at the U.S. Department of Health and Human Services--comes in response to the Biden administration's announcement last month that it intends to invest billions of dollars to expand domestic mRNA manufacturing capacity, with the goal of producing at least one billion Covid-19 vaccine doses per year starting in the second half of 2022.

All three organizations behind the letter have been at the forefront of a campaign calling on President Joe Biden to fulfill his pledge to make the U.S. an "arsenal of vaccines" for the world--publishing detailed plans outlining how the U.S. government can lead the way in rapidly scaling up manufacturing capacity to produce eight billion mRNA vaccines for Covid-19 in one year for as little as $25 billion, or about 3% of the Pentagon's ever-growing budget, and revealing that as of August, Biden had spent less than 1% of available American Rescue Plan funds to ramp up dose production.

In light of that, the coalition said this week that it is "encouraged" by the White House's recent announcement, but also "disappointed the administration did not pursue similar or more ambitious action sooner."

While 8.6 billion Covid-19 vaccine doses have been administered globally so far, just 7.3% of people living in low-income countries have received even a single jab. Africa, in particular, has been abandoned by wealthy governments and Big Pharma, with the World Health Organization warning on Tuesday that the "vaccine-deprived" continent may not reach the goal of inoculating 70% of its population against Covid-19 until late 2024.

The completely avoidable "emergence of the Omicron variant, which experts fear may make current vaccines less effective, has provided a cruel reminder that the world does not have the time to wait," the letter states, a warning that was repeated on Tuesday by WHO Director-General Tedros Adhanom Ghebreyesu. "So long as the United States and other high-income country governments allow the SARS-CoV2 virus to circulate unabated due to insufficient vaccine access, we risk the emergence of more variants."

Zain Rizvi, research director at Public Citizen's Global Access to Medicines Program, told the Washington Post on Wednesday that "the global community is playing variant roulette at this point, and the Biden administration is not being big enough, bold enough, fast enough" to defeat vaccine apartheid.

Alluding to the Biden administration's plan to expand domestic vaccine manufacturing, the coalition wrote that "we are concerned by the intimation from the White House that this new, critical American biosecurity infrastructure will simply be gifted to private companies such as Pfizer or Moderna to operate under their total ownership."

"For this investment to make the impact on supply and access that is needed," the three progressive advocacy groups argued, "it is essential the U.S. government scales the ambition of this plan to produce billions more doses per year and retains ownership over any new domestic manufacturing capacity that is established."

"Allowing Pfizer and Moderna total control over mRNA production and allocation has been disastrous for global vaccine access," wrote the coalition.

Recently compiled data shows that Pfizer and Moderna have sold a lower proportion of doses to low-income countries than other drug manufacturers.

And even though the mRNA technology underlying their shots is the product of years of taxpayer-funded research, the two pharmaceutical giants "so far have refused to share technology with willing and capable manufacturers, despite requests," the letter notes.

Stressing that "publicly financed vaccine production should be publicly controlled," Peter Maybarduk, director of Public Citizen's Global Access to Medicines Program, encouraged the Biden administration to "not repeat the mistake of allowing Moderna and Pfizer to call the shots."

"To ensure newly established domestic manufacturing capacity provides the needed impact to fight Covid-19 and prepare us against future pandemic threats," the coalition argued in its letter, the Biden administration "must pursue a public, government-owned, contractor-operated (GOCO) manufacturing model."

"To avoid pitfalls of past public-private biopharmaceutical manufacturing arrangements and to safeguard public interests," the coalition said, the Biden administration should implement "a well-designed GOCO vaccine manufacturing model" that does the following:

1. Preserves public control over the facility, giving the government the freedom to make critical decisions about operations, manufacturing partners, and technology;
2. Enables transfer of technical know-how for mRNA vaccine production; and
3. Ensures fair pricing and global access.

Regarding the first point, the coalition noted that "government ownership would ensure that U.S. government scientists and manufacturing experts would be able to closely monitor facility activity, and would be able to replace a contractor failing to meet quality standards, should the need arise," such as when Emergent BioSolutions ruined millions of doses of Johnson & Johnson's Covid-19 vaccine in February.

Moreover, "if a different technology is needed to address public health needs," said the coalition, "the United States would have the flexibility to retrofit the facility and shift which product is being manufactured with this capacity."

On the second key point above, the coalition argued that "a GOCO facility could become a training center for other manufacturers," who "are eager to receive know-how and training that would enable them to locally produce mRNA vaccines."

"The global community is playing variant roulette at this point, and the Biden administration is not being big enough, bold enough, fast enough."

As for fair prices and global access, the coalition highlighted how Big Pharma's desire to maximize profits precludes it from equitably distributing lifesaving doses, let alone voluntarily relinquishing its monopolistic control over vaccine recipes, which is supported by the World Trade Organization's corporate-friendly intellectual property rules.

"Moderna and Pfizer are projecting cumulative sales in 2021 of more than $50 billion for Covid-19 vaccines alone," says the letter. "Industry analysts project even greater windfalls in 2022, with Pfizer and Moderna revenues approaching $100 billion."

"Despite these record-shattering revenues," the letter continues, "arrangements Pfizer and Moderna have entered to provide doses to low- and middle-income countries [LMICs] have been grossly inadequate, providing far too few doses, far too slowly, and sometimes only under onerous terms."

"Under a GOCO manufacturing arrangement" by contrast, "the United States government would be able to ensure that LMICs and COVAX have access to the most efficacious vaccines at a reasonable price," the letter adds.

The coalition wrote that "in addition to establishing domestic mRNA manufacturing capacity, the U.S. government should also support developing mRNA vaccine manufacturing capacity throughout the world where vaccines are needed, including in Africa."

On Wednesday, two days after the coalition's letter was sent, public health experts from the AccessIBSA project and the Medecins Sans Frontieres Access Campaign published a report that identifies 120 companies in Africa, Asia, and Latin America that currently have the potential to produce mRNA vaccines for Covid-19 if the necessary knowledge and technology are shared, as Common Dreams reported.

Partners In Health, PrEP4All, and Public Citizen concluded their letter by saying that the "goals of the U.S. government's mRNA production plan should include helping provide billions of doses of highly effective vaccines to the world as quickly as possible and equipping the world with adaptable manufacturing capacity."