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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