President Joe Biden will set a new course for global vaccine allocation this week, hosting a summit on the shortage of shots in poorer countries even as the U.S. moves to give booster doses to millions of fully inoculated Americans.

The U.S. plan for boosters will steer tens of millions of doses into the arms of many U.S. adults starting as soon as Friday. That’s angered nations where many people are still struggling to obtain a first shot. 

As world leaders gather for the United Nations General Assembly in New York this week, Biden aims to counter their criticism by hosting a virtual summit on Wednesday where he’ll propose a target of fully vaccinating 70% of the world by September 2022.

The U.S. has already exported more doses of vaccines than any other country, and Biden’s team wants other wealthy nations to increase their donations to offset any strain on supply from the U.S. booster program. 

But the U.S. government’s booster policy could instead put political pressure on other countries to follow suit with their own plans for extra doses, further exacerbating global inequities.

“It’s like you and I have a life jacket, and they are throwing us one or two more when more than half the planet doesn’t have one,” said Tom Hart, acting chief executive of the ONE campaign, which advocates for vaccine exports to low-income nations.

“Not only is that morally outrageous, it doesn’t make any sense epidemiologically,” he said. “The best way to protect Americans is to extinguish this fire elsewhere as quickly as possible.”

Biden’s team, speaking on a private briefing call last week, stressed that Wednesday’s summit isn’t meant to be a one-day event, but instead the start of a months-long process to set clear international vaccination targets and paths to achieve them, people familiar with the call said.

FDA Vote

In a hearing Friday, U.S. Food and Drug Administration scientists acknowledged the political pressure building around the booster plan. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, began the hearing by asking the panel to focus on the science of booster shots without veering into “issues related to global vaccine equity.”

The panel voted to recommend boosters of the Pfizer Inc.-BioNTech SE vaccine for people 65 years old and older, as well as those with conditions that would put them at higher risk of severe COVID-19. The panel voted 16-2 against recommending boosters for all U.S. adults, as Pfizer had requested.

The FDA will still need to grant final clearance. An outside advisory panel to the Centers for Disease Control and Prevention will also make detailed recommendations for the use of booster shots at a meeting next week. 

The U.S. consumed the first hundreds of millions of doses made on its soil before pivoting sharply to exports once domestic demand slowed. So far, the U.S. has donated and shipped more than 140 million doses abroad.

But the world needs billions of doses to curb the pandemic — a tough goal to meet with donations alone. Many advocates for greater global vaccine equity say Biden should relax legal protections for vaccine formulas and forge deals between manufacturers and facilities in other countries. 

And the UN General Secretary, Antonio Guterres, warned against a U.S. plan for booster shots that would mean fewer vaccinations abroad.

“If to have booster shots in one country means that others will not have shots, of course this is not the best way to deal with the disease,” he said in an interview.

Biden will meet with Guterres on Monday before addressing the UN General Assembly on Tuesday and hosting the vaccine summit.

Donation Red Tape

The U.S. has enough vaccines to give Americans boosters without withdrawing its donation pledges, but “the scope of that expanded access is going to reverberate through the global system,” said Tom Bollyky, director of the global health program at the Council on Foreign Relations.

Some donations have been bogged down by red tape. To send 3.5 million Moderna doses to Argentina in July, for example, U.S. officials had to hash out a nine-step process, including regulatory approval, legal agreements, amending contracts, and even a change in local vaccine regulations. Argentina’s president, Alberto Fernandez, signed a decree smoothing over legal and technical terminology to pave the way for the donation.

U.S. donations have shipped daily or near daily. From the time of production, there is a 96-hour window to pack, ship and deliver frozen vaccines before they spoil. Trucks, planes and even Coast Guard ships are making the deliveries. 

Some countries can’t accommodate Pfizer’s shot, which requires the coldest storage, and some request the Johnson & Johnson vaccine, which only requires one shot. 

“We’re feeling proud of all the work that the U.S. government has done to fulfill the president’s commitment to share vaccines with the world, and we’re looking forward to doing more,” Natalie Quillian, a senior White House official involved in the Covid response, said in an interview last month.

But U.S. officials acknowledge that more needs to be done. The vaccine industry was built to produce between 4.5 billion and 5 billion doses per year, and now needs much greater capacity, one U.S. official said. 

“The U.S. has at least moved 140 million doses of vaccine so far,” said Krishna Udayakumar, founding Director of the Duke Global Health Innovation Center. “That’s still nowhere near the size and scope needed, but puts other countries to shame.” 

‘We Have To Do Both’

Surgeon General Vivek Murthy refuted criticism that the U.S.’s booster program ran counter to helping vaccinate the rest of the world. 

“The notion that somehow us providing adequate protection for the American people is not right, I don’t accept that premise,” Murthy said. “We have to do both. We can’t choose between one and the other.”

But Lawrence Gostin, a Georgetown University law professor and director of the World Health Organization Collaborating Center on Public Health Law & Human Rights, faulted Biden’s booster plan and Murthy’s claim. 

“It defies common sense to suggest that, in the face of extreme global scarcity, that if you use a lot more vaccine at home, that it’s not going to impact the ability to vaccinate abroad,” Gostin said. “The overwhelming reason for the injustice is supply scarcity.”