The Biden administration is planning to invest billions of dollars to expand U.S. manufacturing capabilities of coronavirus vaccines to increase the supply of doses for poorer nations and better prepare the country for future pandemics, the White House said Wednesday.
The announcement received mixed reactions from global health activists, who lauded the investment but raised concerns about the speed of its implementation and the latitude that could be given to pharmaceutical companies. For months, the United States has been under pressure to play a larger role in sharing vaccines with the world, but one administration official, who spoke on the condition of anonymity to disclose private conversations, said some of the advocacy groups specifically lobbied an investment on the scale the United States is making.
Wednesday’s announcement marks the latest partnership between the federal government and pharmaceutical companies to bolster vaccine production during the pandemic.
“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,” said David Kessler, the administration’s chief science officer who oversees vaccine distribution. “We are looking to enter into a historic partnership with one or more experienced pharmaceutical partners. This partnership will be used for covid and any future pandemic viruses with the goal of having enough vaccines available within six to nine months of the identification of the virus.”
The Biomedical Advanced Research and Development Authority (BARDA) has published a “request for information,” seeking proposals from companies that have experience using mRNA technology. BARDA, which is housed within the Department of Health and Human Services, is responsible for developing vaccines and other medical countermeasures.
“It would combine the expertise of the U.S. government in basic scientific research with the robust ability of pharmaceutical companies to manufacture mRNA vaccines,” Jeff Zients, the White House coronavirus coordinator, said Wednesday at the White House’s coronavirus news briefing. “We hope companies step up and act quickly to take us up on this opportunity to expand production of mRNA vaccines for the current pandemic and set us up to react quickly to any future pandemic threats.”
Zients also touted the country’s effort to share vaccines globally, saying the United States has already donated 250 million doses and has committed a total of $1.1 billion. He said the United States has already donated more vaccines than all other countries combined.
Vaccine manufacturers said they were open to the Biden administration’s new plan but were also seeking further details.
In an interview Wednesday, Moderna President Stephen Hoge said that his firm was reviewing the government’s request for information.
“We haven’t talked about it, but the concepts we’re definitely supportive of and would expect to participate in,” Hoge said.
Amy Rose, a spokeswoman for Pfizer, said the company appreciates the administration’s focus on ensuring long term supply, and the company would review BARDA’s “request for information.”
“Pfizer is proud to be a strong and reliable partner to the U.S. government with vast capacity and capabilities that create solutions,” Rose said in a statement. “As we consider the White House’s proposal, we will come to the table with how we can best contribute to the ongoing global fight against the coronavirus.”
But current and former government health officials raised questions about the administration’s newest vaccine manufacturing proposal, suggesting that the White House still needed to flesh out its plan.
“How long will this take — at least nine months? Is it really necessary or will we already basically be done with the need by the time it’s online?” asked one former official who previously worked with BARDA and spoke on the condition of anonymity to discuss the government’s plan.
Since the United States started distributing vaccines, activists have criticized the Biden administration for failing to scale up domestic vaccine manufacturing capacity to boost the global supply of vaccines. Protesters have gathered outside the homes of top officials in Washington in recent weeks, including Zients and White House chief of staff Ron Klain, demanding the White House do more to share vaccines with the world. In September, activists gathered outside Klain’s house and set up a 12-foot pile of fake bones they said symbolized American inaction in combating the global coronavirus crisis.
On Wednesday, some global vaccine activists characterized the administration’s move as a half-measure.
“It’s a positive step that reflects months of activist pressure. However, it is not a substitute for distributed global manufacturing,” said Zain Rizvi, research director at Public Citizen, faulting vaccine manufacturers for not sharing more intellectual property and know-how with the developing world. “Doses are charity. Knowledge is justice.”
Rizvi also listed new questions raised by the administration’s announcement, including what levers the Biden administration is planning to use to compel more production.
“Will the companies that have not played ball for months agree to expand production?” he asked. “Who will control this new production?”
The White House’s announcement comes amid simmering tensions between the U.S. government, vaccine manufacturers and global advocacy groups. While Biden has vowed that the United States will be “the arsenal of vaccines” for the world, and pharmaceutical companies have argued that they are ramping up production to meet global needs, advocates have concerned that developing countries are being left behind. The World Health Organization warned last month that just five of Africa’s 54 nations are set to hit a year-end target of fully vaccinating 40 percent of their residents.
“The U.S. is rightly investing in manufacturing … but in order to gain the upper hand on this and future pandemics, manufacturing should be spread around the world, especially Africa, not limited to the U.S.,” Robbie Silverman, senior advocacy manager for Oxfam America, an organization focused on global inequality, said in a statement.
The United States has also faced criticism for moving forward with booster shots for Americans while many countries are struggling to provide the first round of vaccines to its citizens. The Food and Drug Administration is expected to authorize booster shots of Pfizer-BioNTech’s vaccine for all adults this week after some state officials already widened eligibility in recent days. The FDA approved booster shots for some Americans in September, but the agency is likely to broaden access as evidence shows waning effectiveness of the vaccines over time.
James Krellenstein, co-founder of health equity organization PrEP4All, offered qualified support for the new proposal.
“This is the biggest investment, the biggest move we’ve seen from the Biden administration so far to increase production capability. And that’s a really welcome sign,” Krellenstein said. “But we also have a lot of concerns — in particular, the idea that we could just end up giving a bunch of money to Pfizer or Moderna … which we don’t think would be a sustainable investment in American biosecurity.”
Krellenstein also said that the federal government needed to learn from “the past 30 years of mistakes” of relying on private-sector firms that failed to deliver on promises to fight global health threats, citing the recent cancellation of a coronavirus vaccine contract with manufacturer Emergent BioSolutions as the latest example. “We need the government to realize that there has to be government control” of the manufacturing process, he said.
Krellenstein and other advocates, who first called for the U.S. government to pursue a similar proposal last year, said they were unhappy that the Biden administration had not moved faster to address global manufacturing needs.
“This problem has been really apparent from day one, the fact that we don’t have enough mRNA vaccine manufacturing capacity,” Krellenstein said. “We do need to ask the hard question — what is going at the White House?”
He added: “It’s great that this happened now. But it would be better if it happened in March or April.”
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