The Biden administration is considering donating states’ unused doses of vaccine to countries in need, two senior officials involved in the discussions told POLITICO.
States have built up stores of unused Covid-19 vaccine doses in recent weeks as the number of people signing up for vaccinations has decreased. Some of those spare doses — including tens of thousands of Johnson & Johnson shots — are set to expire at the end of this month.
Senior Biden officials helping to plan how to share U.S. vaccines with other countries are deliberating shipping the surplus doses out before their expiration date, those same two officials said. Another senior administration official said the Biden team is also considering a plan to send abroad doses that will be delivered to states in the coming months but may go unused.
But sending states’ unwanted vaccine to other nations poses several problems. Any country on the receiving end must have a robust distribution infrastructure and the ability to dole out the shots before they expire. The Biden administration also would have to work with receiving countries on contract language that includes an indemnification clause that protects a Covid-19 vaccine’s maker against legal liability for things like adverse reactions to the shot.
The White House has faced growing pressure to donate coronavirus vaccines abroad amid devastating surges of infection in countries like India. Allowing unused doses to expire could further frustrate leaders abroad and American diplomats, and undermine President Joe Biden’s pledge to make America a leader in the world’s pandemic response.
The Biden administration has so far committed to sending 60 million doses of AstraZeneca’s Covid-19 vaccine abroad by July 4. The White House has also said it will send another 20 million doses — some combination of J&J, Pfizer and Moderna shots — by the end of June.
The White House is expected to announce which countries will receive the first U.S. donations as soon as Thursday. One senior administration official familiar with the situation said the administration is only prepared to announce the recipients of the 20 million doses because the Food and Drug Administration is still reviewing the safety of AstraZeneca vaccine manufactured by a contractor, Emergent BioSolutions, whose Covid-19 vaccine production line has been shut down over contamination issues.
The possibility of collecting unused J&J doses from states and redistributing them internationally represents a stunning turn of events for the drug maker. The nation’s only single-dose shot was originally heralded as a critical tool to fight the pandemic, but it has encountered a series of setbacks — including an ongoing shutdown of U.S. production after Emergent, J&J’s American production partner, inadvertently ruined 15 million doses, and an 11-day pause for an investigation of a potential link between the shot and blood clots.
The government has delivered more than 21 million J&J shots to states and federal partners, such as pharmacy chains and community health centers, according to data from the Centers for Disease Control and Prevention. Roughly 11 million have actually been administered.
Several states had discussed in recent weeks the feasibility of sending unused vaccine doses overseas on their own, said Marcus Plescia, the chief medical officer of the Association of State and Territorial Health Officials. But they abandoned those talks once it became clear the federal government was considering a similar approach. States concluded that the administration was better equipped to work out the complicated donation logistics.
“The big concern is that they are going to expire,” Plescia said of the shots. “Some of the doses are just a few weeks away from that.”
One major issue is that states have already distributed some doses to providers and community vaccination sites. Some states are also uncertain about the accuracy of the vaccines’ expiration dates, and how close to that deadline they can still be sent overseas.
“As they get close to expiration date, what are the ethics of trying to ship them off to another country?” Plescia said.
State health officials in Oklahoma are asking the CDC and the White House for help getting the shots into arms before they become unusable.
“We have made suggestions about the possibility of shipping it overseas. Or are there other states in need? Can you direct us where we can send it?” said Keith Reed, Oklahoma’s deputy health commissioner. “And we’ve essentially gotten no answers back at this point of options for us to do anything with this vaccine.”
Arkansas has about 60,000 J&J doses in its possession that are set to expire at the end of the month.
“We’ve been concerned about this for a while,” Jose Romero, the state’s health secretary, said. “The biggest issue is trying to get people to accept the vaccine or overcome the hesitancy that exists in our state.”
In West Virginia, about 25,000 J&J shots won’t be usable after the end of the month. The state has explored whether it can transfer the doses to other states, but there doesn’t appear to be a need, said Clay Marsh, West Virginia’s Covid czar.
The National Security Council — which is coordinating the interagency conversation about deliberation vaccine donations — did not respond to a request for comment. A White House spokesperson also declined to comment, and the Department of Health and Human Services did not respond to a request for comment.
There are several reasons why states have stores of J&J doses near their expiration date, according to state officials. Federal health officials called for a safety pause in the use of the J&J vaccine in April just as supply was beginning to surpass demand in many states across the country. The result was millions of unused doses and uncertainty among state officials about whether the pause reduced demand for J&J’s shot.
“That pause was very much during that shift,” Reed, of Oklahoma, said. “And I think that pause represented quite a bit of missed opportunity to get J&J out there to the public at a pretty critical time.”