Biden's plan to vaccinate the world faces an obstacle: Vaccine manufacturers

U.S. President Joe Biden delivers remarks after touring the General Motors 'Factory ZERO' electric vehicle assembly plant in Detroit, Michigan, U.S. November 17, 2021. REUTERS/Jonathan Ernst
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Earlier this year, President Joe Biden pledged to make the United States "the arsenal of vaccines, as we were the arsenal of democracy during World War II." On Wednesday, his administration took what could be an important step toward that ambition, announcing that the country would invest billions of dollars to expand U.S. manufacturing capabilities so more coronavirus vaccine doses reach poorer parts of the world.

"The goal is to guarantee capacity to produce approximately 100 million mRNA vaccines a month against covid or other pandemic viruses upon demand for the United States or global use," David Kessler, the administration's chief science officer who oversees vaccine distribution, told The Washington Post ahead of Wednesday's announcement.

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The scale of the effort is grand: a public-private partnership aimed at producing at least 1 billion high-quality doses a year by the second half of 2022. The hope is that it could also allow a quick scale-up during future pandemics.

However, the move comes only after months of pressure from public health experts and activists who called on Biden to take urgent steps to ensure global vaccination rates surged, limiting the spread of new, deadlier variants, and potentially wind down the pandemic earlier. Though Wednesday's announcement was generally well received by groups pushing for a fairer global supply of vaccines, many also felt that it didn't go far enough: One group, Public Citizen, had previously called upon the United States to make a $25 billion investment and make 8 billion doses of mRNA vaccine a year.

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"We are heartened, even as we sorely wish the U.S. government had taken far more ambitious and transformative steps six months ago, one year ago, 18 months ago," said Peter Maybarduk, director of Public Citizen's Access to Medicines program, adding that "a major investment to boost mRNA production can help save many lives and potentially even shorten the pandemic."

Oxfam America welcomed the boost to manufacturing in the United States, "in order to gain the upper hand on this and future pandemics, manufacturing should be spread around the world, especially Africa," Robbie Silverman, a senior advocacy manager for the organization, said in a statement.

The new U.S. vaccine plan does highlight one of the big stumbling blocks in supply: the vaccine manufacturers themselves. Two U.S. pharmaceutical companies, Pfizer and Moderna, have produced vaccines that have proved effective at fighting covid-19 using a new type of technology called mRNA. They have also come under criticism for not taking greater steps to increase supply.

Both vaccines have been found to be better than many of their peers at fighting the delta variant. They have been enormous financial boons for both companies, cementing Pfizer as a top-tier pharmaceutical giant and earning the virtually-unheard-of-before-covid Moderna billions in profits. But while both companies were initially praised for their fast-acting ingenuity in the early days of the pandemic, they now face substantial public criticism for an alleged "duopoly."

Pfizer has been accused of extracting harsh terms in negotiations with governments, while Moderna has delayed doses sent to poorer countries. Both Pfizer and Moderna have also fiercely protected their intellectual property and shared little of their expertise, ensuring that other companies couldn't produce massive amounts of generic mRNA vaccines, potentially at cheaper prices.

The companies have made some compromises. Rather than sharing its vaccine recipe with local companies or a South Africa-based tech hub backed by the World Health Organization, Moderna instead pledged to invest up to $500 million for building a new plant that could make 500 million doses of mRNA vaccines last month.

But in general, both companies say the complicated nature of mRNA technology means it is difficult, if not dangerous, to share. Though Pfizer has agreed to license a pill regimen called paxlovid, which can treat covid-19, to a U.N.-backed nonprofit that can share it in low-income nations, it has pushed back at calls to do the same with its vaccine.

"Unlike our oral antiviral, which is a small chemical molecule, high-quality vaccines are large biological molecules that require consistent biological production. It is an extraordinarily complex process under any circumstances, and even more so during a pandemic," Kit Longley, a media representative for Pfizer, told The Post this week, adding that failed vaccine manufacturing could waste resources and cause lapses in consumer trust.

But that's not a matter of consensus. Companies in Africa, South America and parts of Asia recently told the New York Times that they not only have the ability to make these vaccines, but, in some cases, could do it cheaper. In the United States, the Biomedical Advanced Research and Development Authority (BARDA) is seeking proposals from all companies that have experience using mRNA technology, rather than specifically Pfizer and Moderna (the latter firm told The Post it would consider the proposal).

But BARDA's proposals are focused on the United States. And Maybarduk notes that there are more questions about ownership

"Who will control this added capacity? Will it amount to another subsidy to Moderna and Pfizer, or be controlled by, or at least accountable to, the public, including through use of the Defense Production Act?" he asked, referring to a U.S. law that gives the government strong control over industry during times of crisis.

Some argue that the companies should not be involved at all and that the U.S. government needs to take control of some parts of manufacturing. "Throwing more money at anyone holding a monopoly on a vaccine isn't the best option," said James Love, director of Knowledge Ecology International. Love, like other experts, has advocated for the United States to take a tougher approach to ensure intellectual property it helps develop is used wisely.

It's a touchy subject. During an appearance in front of the House Committee on Appropriations on Wednesday, Biden administration officials were pressed on why they had not applied more pressure on companies such as Moderna. The company received nearly $10 billion in research and development money from the U.S. government but is now locked in a dispute about intellectual property with the National Institutes of Health. The coronavirus vaccine is Moderna's only product on the market.

Pfizer, a far bigger and more established company, did not take Operation Warp Speed money to develop its vaccine, as Moderna did. However, it did receive some government help: huge advance orders from the United States, while its German development partner, BioNTech, received money from the German government.

On Wednesday, Kessler pushed back, noting that recently the U.S. government had asked Moderna to work with Covax, a WHO-backed vaccine sharing initiative, and helped broker a deal that would see it supply the African Union with cheaper doses. "A lot to be done," he said. "We are watching closely, and the president is watching closely. These needs are absolutely essential."

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