Posted December 8, 2020 at 7:43pm
President Donald Trump signed a mostly symbolic executive order Tuesday specifying that the United States should get first access to any vaccine, formalizing with fanfare what experts say is already de facto U.S. policy.
“We are the most exceptional nation in the history of the world. Today, we are on the verge of another modern medical miracle,” Trump said in an address at an elaborate “vaccine summit” at the White House. “I’ll sign an executive order to ensure the United States government prioritizes the getting out of vaccines to U.S. citizens before sending it out to other nations.”
But the executive order won’t create any new rules or prevent pharmaceutical companies from entering into bilateral agreements with foreign nations, according to a background briefing with senior administration officials Monday. It’s not clear the administration could prevent pharmaceutical companies from drawing on U.S. plants to satisfy agreements.
“It is not clear to us that this spells out a significant departure in policy,” said Peter Maybarduk, an expert in the pharmaceutical industry and trade at Public Citizen, a consumer advocacy group.
Some global health experts say the “America first” message is counterproductive in a pandemic that easily seeps across borders. Advocates for greater global access to vaccine technology describe this position as “vaccine nationalism.”
“The notion that Trump will be able to prevent future exports of vaccine beyond his tenure as president is probably misguided,” said Gavin Yamey, a Duke University expert in global health. “This may all be jingoistic, nationalistic ‘America First’ chest thumping.”
The executive order comes amid the revelation that millions of doses of the first available COVID-19 vaccine, manufactured at a U.S. plant, will be shipped overseas in early spring, months before most Americans have gotten their first shot.
Former Food and Drug Administration Commissioner Scott Gottlieb, who sits on the Pfizer board of directors, said that some supply of the COVID-19 vaccine manufactured at a Michigan plant would be exported to fulfill the company’s contracts with foreign nations.
“All of the supply coming out of that Michigan facility will be going to the United States for the first quarter of 2021,” Gottlieb said in an interview with CNBC. “Pfizer did offer another allotment, basically the second quarter allotment coming out of that plant, to the United States government multiple times.
“There is supply from that [Michigan] plant that’s going to come into the United States in the second quarter. It’s just not all of the supply,” he added.
The U.S. government’s agreement with the company conserved 100 million doses, enough to inoculate 50 million people, should the FDA authorize it, Gottlieb said. That supply is expected to run dry by April 2021.
The most recent offer for more supply was extended after the company announced interim results that the vaccine was highly effective on Nov. 9. Pfizer entered into a supply agreement with the European Union for 200 million doses on Nov. 11.
“If a contractor is meeting dose requirements to the [U.S. government], then nothing in the contract would prohibit sale of a manufacturer’s excess doses to another country,” an HHS spokesperson said in a statement. “OWS is doing everything possible to responsibly obtain enough doses of FDA authorized vaccines for all Americans in record time. Additionally, most OWS contracts are rated under the Defense Production Act, meaning the contractors must prioritize the Government’s orders for doses above others.”
The spokesperson also said there are ongoing negotiations to procure more doses.
The backlash also comes amid further evidence that the vaccine, co-developed with German biotech BioNTech, is highly effective.
The FDA said that the drugmaker’s data satisfies its requirements for an emergency authorization in documents published ahead of a key meeting of its outside vaccine advisors Thursday. An authorization could follow in the days after that.
At the White House summit, which involved a key FDA official, governors, Operation Warp Speed officials and CEOS of shipping and pharmacy corporations, the president cheered the scientific achievement of developing vaccines in record time.
Conspicuously absent, as predicted, were executives from the manufacturers, Pfizer and Moderna.
Jesse Goodman, a vaccines expert and former FDA official, called the executive order’s message “extreme.”
“Obviously each country has to look out for its citizens, but this strikes me as extreme,” he said. “I think that it’s legitimate to make sure the U.S. benefits from U.S. investments but this seems more along the lines of protectionism than public health.”
Trump said the U.S. government could invoke the Defense Production Act to prevent supplies from being exported, but acknowledged that is unlikely.
Goodman said that could lead to retaliation by other nations that manufacture vaccine ingredients and other ancillary supplies essential for a national vaccination program like personal protective equipment.
“It could really backfire,” he said.
Operation Warp Speed top scientist Moncef Slaoui expressed uncertainty about what the executive order accomplishes in an interview with ABC Tuesday morning.
“Frankly, I don’t know,” Slaoui said in response to a reporter’s request for details.
The executive order included a section saying USAID, the Department of Health and Human Services, the State Department, the Export-Import Bank, the U.S. International Development Finance Corp. and other agencies are to work on making vaccine available to other countries after every American is vaccinated.
“We have great companies and we’re working with the world,” Trump said.
The executive order could also make it more politically risky for the incoming Biden administration to discuss participation in COVAX, a World Health Organization-backed effort to increase access to the vaccine in countries that are not as wealthy as the U.S.
“Trump’s laying a trap for people who are more globally minded,” said Maybarduk. “It’s obviously a difficult question to address global sharing when we’re still waiting for access at home.”
Maybarduk said it’s understandable that national leaders would seek to immunize their nation’s citizens first, but there are unused levers that can increase the supply for everyone.
“The U.S. government can expand the supply of vaccines everywhere by scaling up manufacturing, sharing technology with the World Health Organization, and teaching the world to make safe and effective vaccines,” he said.
The chief obstacle, Maybarduk said, is that Pfizer and Moderna plan to make a profit on the COVID-19 vaccines, and are safeguarding their intellectual property.
The U.S. has the worst COVID-19 outbreak in the world, according to WHO data.