Behind Biden’s pledge to share 80 million vaccine doses: Lots of bureaucratic hurdles

WASHINGTON – When a commercial plane carrying 2.5 million doses of Moderna’s coronavirus vaccine departed from Dallas for Islamabad, Pakistan, on Wednesday, federal officials scrambled a dizzying bureaucracy back and forth to get them there.

The United States had arranged a donation agreement with Moderna and kovax, the year-old vaccine-sharing initiative. Kovax previously worked out an indemnity agreement with Moderna, which protects the company from liability for potential harm from the vaccine. US Embassy officials in Islamabad worked with regulators there to evaluate a vaccine review by the Food and Drug Administration; Pakistani regulators had to pay attention to the plethora of ingredients before authorizing vaccines for use in the lot and factory where they were made.

Once they signed, the result was a so-called tripartite agreement: a deal of sorts that has increasingly come to consume the Biden administration’s pandemic response efforts, outlining how Demand for vaccines is lagging in the United States As many countries ask for help from people in surplus.

amid criticism from some public health experts that President Biden’s Vaccine Diplomacy Efforts have been slow and insufficient, with the White House planning to announce 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 nearly 50 countries, the African Union and the African Union. Of the 20-nation Caribbean consortium, about half have already been shipped and the rest will be determined 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 churning of activity in the federal government, with sub-level meetings and daily operations calls several times a week. The White House can hold up to 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 routed through Covax, which includes Over 91 million doses shipped overall both rich and low-income countries. The rest is being shared through bilateral deals, in which countries can receive 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, millions of doses of the three federally authorized vaccines have been lying unused in the United States, and are constantly coming off supply lines. White House officials said they were aiming to guarantee enough supplies for Americans this spring before completing additional shipping overseas.

So far, more than three billion vaccine doses have been administered administered worldwide, equivalent to 40 doses for every 100 people. Some countries have yet to report a single dose, even when highly contagious Delta version spread around the world, further exposing the inequalities.

Dr. Saad B. Omar, director of the Yale Institute for Global Health, said of the US effort, “If this momentum continues, it is, unfortunately, too slow.”

Ms. Quillian said more doses would be shipped in the summer, in addition to Pfizer-BioNtech’s 500 million doses of vaccine The Biden administration pledged to distribute this month to about 100 countries next year. He described this phase of vaccine diplomacy as more procedurally complex than the domestic vaccination programme. Among the challenges with bilateral deals, such as 3 million doses of Johnson & Johnson’s vaccine sent to Brazil Last week: The recipient nation is negotiating indemnity agreements with manufacturers.

Since the doses bound for Pakistan were declared ready for shipment last week, the focus shifted to packing and transporting them to the Dallas airport. Health officials in Pakistan and the 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 The population of Pakistan has been fully vaccinated.

Dr. Hilary D. Marston, a member of the administration’s COVID-19 response team and a former official with the National Security Council and National Institutes of Health who helped coordinate the shipment, said the State Departments and the Centers for Disease Control and Prevention It also worked with Pakistani authorities to understand how many doses the country was capable of storing.

Pakistan was an obvious candidate for vaccine donation, Ms Quillian said. as a neighbor India, which suffered a devastating surge in virus cases this spring, was likely to be affected by the spread of Pakistan’s delta variant, which was Identified for the first time in India. But the list of countries to which the United States has sent vaccines warrants further deliberation.

White House National Security Adviser Jake Sullivan said at a news briefing this month that the administration was initially prioritizing the United States and its neighbors in Asian countries with a surge in virus cases.

Dose sharing can sometimes take the form of an international matchmaking scheme. Some countries have requested Johnson & Johnson vaccines because of its easy storage requirements and its appeal. one-and-done Shot Others has already authorized one or more vaccines to be used in the United States, speeding up the process.

“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.”

Officers can still run into significant roadblocks. Because donated supplements were produced and sold under US legal and regulatory processes, they have to be approved separately by the countries receiving them. This process often involves coordinating with foreign regulators.

Covax dosage use can sometimes be stopped, such as in South Sudan and Congo, which both returned something to the initiative due to logistical problems and vaccine hesitation. There have been clear successes in bilateral deals that 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. Omar said targeting donations to countries with outbreaks was insufficient, because of the time it takes for vaccines to boost an immune response.

Regarding the dose-sharing campaign, he said, “Since the start of the vaccination program, it took us six months to have some concrete movement on this topic.”

Ms Quillian defended the administration’s timing. “It is difficult to remember 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 ourselves first and demonstrate that it could work here, and then we always wanted to share when we had a surplus.”

Biden administration, Dr. Omar said, needs to lean more on CDC’s expertise global vaccination campaign, including its successes in streamlining the distribution of polio vaccines.

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

White House officials said the CDC’s disease outbreak forecasting work has recently received a financial boost from Biden’s US rescue plan, which will improve the White House’s efforts to identify potential virus hot spots overseas. He said a more organized program is underway to make that work.

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