Why Distributing Excess US Covid Vaccine Doses Is Harder Than Planned

It's not just a question of sending doses; recipient countries have specific requests based on their needs and perceptions of vaccines' efficacy. 

And they often insist on negotiating with manufacturer to reduce legal liability for both sides. The processes involved are taking longer than expected. JL 

Noah Weiland reports in the New York Times:

Since the donated doses were produced and sold under American legal and regulatory procedures, they have to be approved by the countries receiving them. The process involves working out kinks with foreign regulators. This phase of vaccine diplomacy is more procedurally complex than domestic inoculation. Among the challenges with bilateral deals is the recipient nation negotiating indemnity agreements with the manufacturers. Some countries have requested J&J’s vaccine because of easier storage and its appeal as a one-and-done. Others (want) vaccines used in the US, making the process faster.

When a commercial plane carrying 2.5 million doses of Moderna’s coronavirus vaccine took off on Wednesday from Dallas for Islamabad, Pakistan, federal officials had just finished a dizzying bureaucratic back-and-forth to get them there.

The United States had arranged a donation agreement with Moderna and Covax, the year-old vaccine-sharing initiative. Covax had previously worked out indemnity agreements with Moderna, which shield the company from liability for potential harm from the vaccine. American Embassy officials in Islamabad had worked with regulators there to evaluate the Food and Drug Administration’s review of the vaccine; Pakistani regulators had to pore over reams of materials on the vaccine lots and the factory where they were made before authorizing it for use there.

Once they signed off, the result was a so-called tripartite agreement: a type of deal that has increasingly come to consume the Biden administration’s pandemic response efforts, underscoring how demand for vaccines is lagging in the United States as many countries plead for help from those with a surplus.

Amid criticism from some public health experts that President Biden’s vaccine diplomacy efforts have been slow and insufficient, the White House plans to announce on Thursday that it has fulfilled the president’s pledge to share an initial 80 million doses by June 30. More than 80 million have been formally offered to about 50 countries, the African Union and the 20-nation Caribbean consortium, with around half already shipped and the rest to be scheduled in the coming weeks, said Natalie Quillian, the Biden administration’s deputy Covid-19 response coordinator.

The dose-sharing effort has evolved into a constant churn of activity across the federal government, with deputy-level meetings several times a week and daily operations calls. The White House can hold as many as 15 country-specific calls a day, beginning at 7 a.m. and often involving the National Security Council, the Centers for Disease Control and Prevention, the State and Defense Departments and other agencies.

About 75 percent of the doses are being routed through Covax, which has shipped more than 91 million doses in all, to both wealthier and lower-income nations. The rest are being shared through bilateral deals, in which countries can retrieve and distribute doses more directly.

Researchers have estimated that 11 billion doses of vaccines are needed worldwide to potentially stamp out the coronavirus pandemic. In recent months, tens of millions of doses of the three federally authorized vaccines have been sitting unused in the United States, with more continually coming off supply lines. White House officials said they were aiming to guarantee adequate supply for Americans this spring before completing the work of shipping excess overseas.

To date, more than three billion vaccine doses have been administered worldwide, equal to 40 doses for every 100 people. Some countries have yet to report a single dose, even as the highly contagious Delta variant spreads around the world, further exposing inequities.

“If this is the pace at which it will continue, then unfortunately, it’s much slower than what is needed,” Dr. Saad B. Omer, the director of the Yale Institute for Global Health, said of the U.S. effort.

Ms. Quillian said that more doses would be shipped over the summer, in addition to the 500 million doses of Pfizer-BioNTech’s vaccine the Biden administration pledged recently to distribute among about 100 countries over the next year. She described this phase of vaccine diplomacy as more procedurally complex than the domestic inoculation program. Among the challenges with bilateral deals, like with the three million doses of Johnson & Johnson’s vaccine sent to Brazil last week: the recipient nation negotiating indemnity agreements with the manufacturers.

As the doses bound for Pakistan were declared ready for shipment last week, attention shifted to packing and moving them to the Dallas airport. The health authorities in Pakistan and an organization behind Covax — UNICEF, the United Nations agency for children — will deliver them, an effort the Biden administration plans to monitor. Less than two percent of Pakistan’s population is fully vaccinated.

Dr. Hilary D. Marston, a member of the administration’s Covid-19 response team and a former official at the National Security Council and the National Institutes of Health who has helped coordinate the shipments, said that the State Department and the Centers for Disease Control and Prevention had also worked with Pakistani officials to understand how many doses the country was able to store. Pakistan was an obvious candidate for vaccine donation, Ms. Quillian said. As a neighbor to India, which faced a devastating surge of virus cases this spring, Pakistan was likely to be affected from the spread of the Delta variant, which was first identified in India. But the broader list of countries the United States has sent vaccines to required more deliberation.

Jake Sullivan, the White House national security adviser, said at a recent news briefing that the administration was initially prioritizing neighbors of the United States and Asian countries with surges in virus cases.

Sharing doses can sometimes take on the appearance of an international matchmaking scheme. Some countries have requested Johnson & Johnson’s vaccine because of easier storage requirements and its appeal as a one-and-done shot. Others have already authorized one or more of the vaccines used in the United States, making the process faster.

“Every country we’ve offered a vaccine to,” Ms. Quillian said, “when they’ve asked for a specific type, we’ve been able to meet that request.”

Officials can still run into significant hurdles. Since the donated doses were produced and sold under American legal and regulatory procedures, they have to be separately approved by the countries receiving them. The process often involves working out kinks with foreign regulators.

Use of Covax doses can sometimes stall, like in South Sudan and Congo, which both returned some to the initiative because of logistical problems and vaccine hesitancy. There have been clearer successes in bilateral deals the United States has already negotiated. South Korea, which received a million doses of Johnson & Johnson’s vaccine from the United States, reported that it had used 99.8 percent of the doses in a few weeks, White House officials said.

Dr. Omer said that because of the time it takes for vaccines to prompt an immune response, targeting donations to countries with outbreaks was inadequate.

“It took us six months, even since the start of the immunization program, to have certain substantive movement on this topic,” he said of the dose-sharing campaign.

Ms. Quillian defended the administration’s timing. “It’s hard to remember back to three months ago, or even February or January. We didn’t have enough vaccine for this country,” she said. “The president wanted to make sure we could take care of our own first and demonstrate that it can work here, and then we always wanted to share if we had surplus.”

The Biden administration, Dr. Omer said, needed to lean more on the C.D.C.’s expertise in global inoculation campaigns, including its successes in organizing the distribution of polio vaccines.

Dr. Michael H. Merson, a professor of global health at Duke University and a former director of the World Health Organization’s Global Program on AIDS, said that a useful model for distributing vaccines abroad would be the President’s Emergency Plan for AIDS Relief, or Pepfar, which has worked with The Global Fund to deliver, administer and monitor the safety of antiretroviral drugs.

The C.D.C.’s disease outbreak forecasting operations recently received a financial boost from Mr. Biden’s American Rescue Plan, which would improve the White House’s efforts to identify potential virus hot spots abroad, White House officials said. A more organized program to do that work is getting underway, they said.