Why the U.S. Still Can’t Donate COVID-19 Vaccines to Countries in Need

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The immediate goal was to “vastly increase” America’s supply, but the extra doses could also be used to supply the world, said a senior Biden official: “Just connect the dots. There’s a real ability for the U.S. to become a major supplier” of COVID vaccines.

The federal government began thinking through what to do with its surplus doses long before any vaccines were even approved. At the end of last July, Secretary of Health and Human Services Alex Azar convened a group to develop a strategy for global sharing. The U.S. Agency for International Development (USAID) joined the effort, but the Defense Department, which negotiated the contracts with vaccine manufacturers, declined to engage. “DOD gave us the middle finger,” a source involved in the effort said. “They literally would not attend meetings.” (A Defense Department spokesperson said, “DoD and HHS have been working closely to determine how to handle excess doses” since the beginning of Operation Warp Speed.)

The National Security Council’s Resilience Directorate, which coordinated key aspects of the U.S. COVID response, stepped in to help guide the debate. In a series of meetings over September and October, an interagency group that included the State Department, the Defense Department, and divisions of the Health and Human Services Department, among others, assessed the array of obstacles that stood in the way of the U.S. helping the world, from FDA regulations and export laws to chain-of-custody issues. Questions abounded: Should the U.S. sell its surplus? Donate it? Subsidize the cost?

At the heart of the debate was a battle over an essential question: how to define the point at which the U.S. could donate its excess vaccine. Was it when the U.S. reached herd immunity? When enough vaccines for every eligible American were under contract to be produced? Or when 70% of the population was vaccinated? “We kicked around a lot of indicators,” said a former senior administration official who worked on the document. “The one that became the most cut and dry was the quantity produced and the population vaccinated.”

That effort led to the creation of The Framework for International Access, which affirms that the U.S. intends to share its doses and will do so multilaterally. The document had two versions: one that came to roughly four pages, and a longer one, as well as a spreadsheet that assessed the needs of each country that might receive vaccines. Several countries were pointedly excluded from the list of prospective recipients, said the former senior administration official, due to their instability or human rights records.

In November, the document was cleared to be elevated to the National Security Council’s Principals committee. “We were told to prepare for a rollout,” said the senior administration official. On January 5, a four-page version of the Framework made it to the desk of Deputy National Security Adviser Matthew Pottinger. But the next day, MAGA insurrectionists stormed the Capitol. By that afternoon, Pottinger had resigned. The Framework’s authors assumed that the document, and the months of work that went into it, were dead. “Just another project sent to the buzz saw,” said the former senior administration official.

Globally minded government officials braced for the fallout. “We are preparing for extreme backlash from the world for not sharing,” said the senior government official. “When they say we are hoarding, we are.”

But the Framework document lived on. One of Biden’s first memoranda, dated January 21, directed the Secretaries of State and Health and Human Services to “promptly deliver to the President” a “framework for donating surplus vaccines.” And it appeared that the document was moving closer to Biden’s desk—until the meeting last Wednesday.

The officials present at the White House meeting deadlocked over next steps for the Framework. Several attendees argued passionately that the document should be elevated immediately to the National Security Council’s Principals Committee, comprising the president’s top advisers and Cabinet secretaries. The argument for doing so was obvious: The longer the virus proliferates around the globe, relatively unimpeded by vaccines, the more likely it is to mutate and spawn dangerous variants. “The people who really live and breathe global health understand how dire it is,” said the senior official. But those involved in the White House’s domestic COVID-19 response apparently made clear to the group: Now is not the time.

Said the senior official with knowledge of the meeting, “They’ve put the brakes on, until someone higher can figure this out.”

A series of scares in the early 2000s, including the 2001 anthrax attacks on members of Congress and the press and the 2004 worldwide outbreak of H5N1 “bird flu,” prompted Congress to pass the Public Readiness and Emergency Preparedness (PREP) Act. The 2005 law gives manufacturers of vaccines and therapeutics developed in response to public health emergencies sweeping protection from liability, and makes the U.S. government a guarantor of that protection.

The law provides an “almost Star Trek–level ‘shields up,’” said Nicholas Pace, a senior social scientist at the RAND Corporation. But “the moment that vial walks across the border, PREP has no effect. The cross-border liability problem is a huge one.”

According to a briefing document prepared during the Trump administration for the National Security Council, a portion of which was obtained by Vanity Fair: “This type of liability protection is unique in the world; most other countries provide no protection at all and only in some cases provide some level of legal protection.” 

In the wake of such woebegone public health campaigns as the U.S. government’s 1976 mass vaccination against swine flu, which led to numerous cases of paralysis from Guillain-Barré syndrome, liability exposure has become the “third rail for these companies,” a senior Biden official acknowledged. “They are not going to do business unless they’re protected.” Paul Mango, a Trump administration Operation Warp Speed official, put it another way: “If I am a vaccine manufacturing CEO, I did not sign up to do this so that I would be liable to Ethiopia.”

Operation Warp Speed seemed to bend over backward to avoid that possibility, agreeing to a sweeping restriction that prevents the United States from sharing its bounty and thereby reaping any diplomatic rewards.

Experts say the Trump administration—which, after all, was in the position of doling out billions of dollars in development funds—was not required by any law to roll over for the vaccine makers. Sam Halabi, a scholar at the O’Neill Institute for National and Global Health Law at Georgetown University, who is currently advising several international organizations involved in the global vaccination effort, said the U.S. had been in “a very good position to call the manufacturers’ bluff: ‘if you want the billions in procurement dollars then we want the flexibility to send’” doses overseas. But U.S. negotiators likely “didn’t have any interest in sharing outside of U.S. territory.”

By contrast, during the H1N1 flu outbreak in 2009, a U.S. donation campaign was planned early and geographic restrictions were not imposed, said a former Obama administration official who had helped plan H1N1 vaccine donations. Given that history, “I am really surprised the U.S. would agree to constrain its options,” said the official, after being read the contract language by Vanity Fair.

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