Vaccine recall, Biden export plans collide at the top

US President Joe Biden will set a new direction for global vaccine allocation this week, hosting a summit on vaccine shortages in poorest countries as the US prepares to give booster doses to millions of fully immunized Americans.

The U.S. plan for boosters will direct tens of millions of doses into the arms of many U.S. adults starting Friday. This has angered nations where many people are still struggling to get a first hit.

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 will propose a goal to fully immunize 70% of the world by September 2022. .

The United States has donated more doses of the vaccine than any other country, UNICEF data shows, and Biden’s team wants other wealthy countries to increase their donations to offset any pressure on supply of the American recall program. The administration is negotiating with Pfizer Inc. to purchase 500 million more vaccines to donate globally, which would double the United States’ commitment to help poorer countries.

But the US government’s recall policy could instead put political pressure on other countries to follow suit with their own plans for further doses, further exacerbating global inequalities. The Pfizer deal is expected to be announced in the coming days, ahead of Wednesday’s virtual vaccine summit. The White House declined to comment on any planned purchases.

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

“Not only is it morally outrageous, it makes no epidemiologic sense,” he said. “The best way to protect Americans is to put out this fire elsewhere as quickly as possible.”

Biden’s team, speaking on a private conference call last week, said Wednesday’s summit was not meant to be a one-day event, but rather the start of a process of several months to set clear international immunization goals and pathways to achieve them, people familiar with said the call.

In a hearing on Friday, scientists from the U.S. Food and Drug Administration acknowledged growing political pressure around the stimulus package. 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 injections without looking at “issues of global vaccine fairness.” .

People line up at a COVID-19 vaccination site in Managua, Nicaragua on Monday. | REUTERS

The panel voted to recommend recalls of the Pfizer Inc.-BioNTech SE vaccine for people 65 years of age and older, as well as those with conditions that would put them at a higher risk of severe COVID-19. The panel voted 16-2 against the recommendation of boosters for all American adults, as requested by Pfizer.

The FDA will still need to grant final clearance. And an advisory group outside the Centers for Disease Control and Prevention will also make detailed recommendations for the use of reminders at a meeting next week.

The United States consumed the first hundreds of millions of doses produced on its soil before switching sharply to exports once domestic demand slowed. So far, the United States has donated and shipped over 140 million doses overseas.

But the world needs billions of doses to curb the pandemic – a goal difficult to achieve with donations alone. Many advocates for greater global vaccine fairness say Biden should relax legal protections for vaccine formulations and strike deals between manufacturers and facilities in other countries.

And UN Secretary-General Antonio Guterres has warned of a US recall plan that would mean fewer vaccinations abroad.

“If having boosters in one country means others won’t have vaccines, of course, that’s not the best way to fight the disease,” he said in an interview.

Biden met with Guterres on Monday before addressing the United Nations General Assembly on Tuesday and hosting the vaccine summit.

The United States has enough vaccines to give Americans reminders without withdrawing their pledges, but “the scope of this expanded access is going to spill over into the global system,” said Tom Bollyky, director of the global health program at the United States. Council on Foreign Relations.

Some donations have been bogged down by bureaucracy. To send 3.5 million doses of Moderna to Argentina in July, for example, US officials had to put in place a nine-step process, including regulatory approval, legal agreements, contract changes, and even a change in policy. local vaccine regulations. Argentine President Alberto Fernandez signed a decree smoothing legal and technical terminology to pave the way for donation.

American donations were dispatched daily or almost daily. From the time of production, there is a 96-hour window to package, ship and deliver frozen vaccines before they spoil. Trucks, planes and even Coast Guard ships make the deliveries.

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

“We are proud of all the work the US government has done to fulfill the President’s commitment to share vaccines with the world, and we look forward to doing more,” said Natalie Quillian, senior official at the House. Blanche involved in the COVID-19 response, said in an interview last month.

But US officials recognize that more needs to be done. The vaccine industry was designed to produce between 4.5 billion and 5 billion doses per year, and now needs much more capacity, a US official said.

“The United States has so far moved at least 140 million doses of vaccine,” said Krishna Udayakumar, founding director of the Duke Global Health Innovation Center. “It’s still a long way from the size and scope needed, but it puts other countries to shame.”

Surgeon General Vivek Murthy has rebutted criticism that the US recall program runs counter to vaccinating the rest of the world.

“The idea that somehow we are providing adequate protection to the American people is not fair, I do not accept that premise,” said Murthy. “We have to do both. We cannot choose between one and the other.

But Lawrence Gostin, a law professor at Georgetown University and director of the World Health Organization’s Collaborating Center on Public Health Law and Human Rights, blamed Biden’s recall plan and Murthy’s assertion.

“It defies common sense to suggest that, in the face of an extreme global shortage, if you use a lot more vaccines at home, it won’t impact the ability to vaccinate abroad,” Gostin said. . “The main reason for the injustice is the scarcity of supply. “

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