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0519 Biden COVID
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Policy, Politics & Law

Biden administration acting slowly to address global needs for COVID vaccines

Global health policy groups call for bolder U.S. leadership on COVID-19 vaccine supply, manufacturing

Global health policy groups call for bolder U.S. leadership on COVID-19 vaccine supply, manufacturing

May 19, 2021 | 12:29 AM GMT

The Biden administration has promised to lead a global initiative to bring COVID-19 vaccines to billions of people in Africa, Asia and South America. The plans it has announced, however, do not come close to matching the scale or the urgency that global health policy groups say is needed.

They argue the administration’s policies — supporting a WTO waiver for COVID-19 vaccine IP, promising modest shipments of American-made vaccines, and calling for other wealthy countries to collaborate to increase manufacturing capacity — will not put the U.S. on a course to make a large dent in global demand.

President Joe Biden’s promise of American pandemic response leadership “is a good start, but it is a small start. It doesn’t reflect either the global need or the resources the U.S. can bring to bear,” Krishna Udayakumar, head of the Duke Global Health Innovation Center, told BioCentury.

To make headway on ending the pandemic, the U.S. should mobilize financial and technical resources and form collaborations with biopharmaceutical companies at a magnitude and speed similar to the Operation Warp Speed push that made it possible to vaccinate every American and has produced a surplus of vaccines that can be shared internationally, Udayakumar said. 

Global health policy organizations affiliated with Duke University have mapped out a strategy for the U.S. to take a bolder approach than the Biden administration has described.

The health policy think tanks estimate that the U.S. could provide hundreds of millions of doses of COVID-19 vaccines to the rest of the world this summer and that it could start shipping them immediately.

The U.S. could also play a more robust role in ending the pandemic worldwide by increasing financial support to COVAX, an international initiative that seeks to provide equitable global access to COVID-19 vaccines, and by increasing manufacturing capacity at home and around the world, the Duke teams recommend.

80 million doses

In a speech Monday,  the president said the U.S. will share 80 million COVID-19 vaccine doses with the rest of the world over the coming six weeks, increasing a commitment the U.S. made in April by 20 million doses.

The U.S. has shipped four million doses of vaccine from AstraZeneca plc (LSE:AZN; NASDAQ:AZN) to Canada and Mexico, and in April the Biden administration announced its intention to supply an additional 60 million doses of the vaccine, enough to vaccinate 30 million people, to countries that have urgent unmet needs.

Export of the AstraZeneca vaccine doses is on hold pending sign-off from FDA.

FDA has not authorized use of the AstraZeneca vaccine in the U.S., but authorization is not necessary for vaccines to be shipped to other countries.

The doses that are slated for shipment overseas were manufactured under contract from the U.S. government by Emergent BioSolutions Inc. (NYSE:EBS) at a facility that has experienced repeated, serious safety and quality problems. FDA has not publicly identified problems with the AstraZeneca vaccine manufactured at the facility.

Udayakumar is critical of both the timing and the scale of the vaccine sharing commitment, suggesting that FDA is not clearing the AstraZeneca vaccine doses as quickly as it could. “We have doses we can send tomorrow. Why do we have to wait six weeks? People are dying today.”

He added that there is no clear timeline on when the AstraZeneca doses will be made available. “There seems to be a lack of urgency in how quickly we are moving here.”

An FDA spokesperson told BioCentury the agency cannot comment on the timing or procedures for clearing the AstraZeneca vaccine doses. 

To reach the 80 million doses, the U.S. will supplement the AstraZeneca doses with doses of FDA-authorized COVID-19 vaccines manufactured in the U.S. by or for Pfizer Inc. (NYSE:PFE), Moderna Inc. (NASDAQ:MRNA) and Johnson & Johnson (NYSE:JNJ), Biden said.

An analysis conducted by researchers at institutes affiliated with Duke University estimates that the U.S. could meet domestic demand, including vaccinating children and providing booster shots in the fall, and still share with the world 300 million or more doses of vaccines by the end of July. Additional doses could be available later in the year.

The estimate assumes authorization of the COVID-19 vaccine that Novavax Inc. (NASDAQ:NVAX) is developing, and that Pfizer and BioNTech SE (NASDAQ:BNTX), Moderna, Johnson & Johnson and AstraZeneca all meet their production goals.

Too little, very late

Biden’s announcements came hours after the release of an open letter urging the U.S. government to assert leadership to address the global COVID-19 crisis. The letter was signed by leaders of the Center for Global Development, Duke-Margolis Center for Health Policy, Duke Global Health Innovation Center, Duke Global Health Institute, the Center for Strategic and International Studies, and the COVID Collaborative, a group that includes scores of academic centers, companies and trade associations.

The signers urged Biden to reject the America First policies of the Trump administration and engage with other world leaders to bring vaccines to the entire world. “The world is now in great need of high-level engagement that up to now has been conspicuously absent — to mitigate death and suffering in the short term, chart a sustained exit from the COVID-19 pandemic in the medium term, and insure against another global pandemic in the long term.” They added: “American leadership is required to ensure universal global access to high-quality and safe vaccines, support rapid vaccine distribution and administration, and build a sustainable global network of vaccine manufacturing capacity.”

The letter pegs U.S. spare COVID-19 vaccine capacity over the next three to six months at “several hundred million doses.” The estimate assumes that the U.S. will require sufficient doses for its entire population and for booster doses. 

The Duke policy groups estimate that by fall, COVID-19 manufacturing in the U.S. will exceed 300 million doses per month.  

In addition to releasing these doses, the letter calls on the Biden administration and Congress to lead a global program to increase worldwide vaccine manufacturing capacity to meet the needs of people living outside the world’s wealthiest countries.

“Forty-six percent of Americans and over a quarter of Europeans have received at least one dose of a COVID-19 vaccine, but only 14% of those in South America, 4.8% in Asia, and 1.2% in Africa,” the letter notes. “Addressing this inequity requires an urgent mobilization that adapts the successes achieved in the U.S. to bring the same benefits to all those in dire need as quickly as possible.”

The open letter called for the Biden administration to appoint a White House Global Coronavirus Response Coordinator who would work closely with the White House Coronavirus Response Coordinator Jeff Zients. Biden did this by expanding Zients’ job to include responsibility for a global portfolio. 

“It isn’t clear that a single individual can handle both jobs, but if anyone can do it, Zients can do it,” Udayakumar told BioCentury.

The Duke policy groups highlighted the need to go beyond the goals set by COVAX, stating that “even if COVAX, the global COVID-19 vaccine mechanism, were to be fully funded this year, it would still vaccinate only 20-25% of the population of the world’s 92 poorest countries. At the current rate, these countries may not reach 60% coverage until 2023 or later.”

One billion doses possible this year

The U.S. will work with COVAX “and other partners to ensure that the vaccines are delivered in a way that's equitable and follows the science and public health data,” Biden said.

He also alluded to a broader initiative to increase COVID-19 vaccine supplies.

“In the weeks ahead, working with the world's democracies, we'll coordinate a multilateral effort to end this pandemic. I expect to announce progress in this area at the G-7 summit in the United Kingdom in June, which I plan on attending.”

A White House fact sheet states that “over the coming weeks, the U.S. will use its leadership working with our G7 partners, the EU, COVAX, and others to coordinate a multilateral effort focused on ending the pandemic. Specifically, we seek to garner concrete, deliverable commitments from other governments and private sector partners to make available more vaccines, spur production and manufacturing for vaccines and raw materials, get shots into arms around the world, and provide health security assistance to save lives, stop the spread of COVID-19, reduce the lifespan of this pandemic, and recover economically.”

Biden did not disclose his goals for the meeting.

The open letter from U.S. global health and COVID groups suggested that the U.S. “could significantly boost global efforts by collaborating with other G7 nations to pledge at the June G7 Leaders’ Summit to collectively share at least 1 billion doses by the end of 2021.”

Biden said that in addition to donations of surplus vaccines, “what we need to do is lead an entirely new effort, an effort that works with the pharmaceutical companies and others and partner nations to vastly increase supply.”

Biden said the U.S. will lead an initiative to create vaccine manufacturing capacity “that can beat this pandemic worldwide” and suggested that much of the manufacturing will be conducted in the U.S. “in a way that creates jobs here at home and saves lives abroad.”

The open letter calls for the U.S. to expand domestic production while coordinating with manufacturers in other countries that could plug gaps that are limiting the amount of vaccine available to the world. It says the U.S. should  “finance the accelerated buildout of additional short-term manufacturing capacity for U.S.-authorized vaccines, including ingredient processing, bulk drug production, and fill-finish, with the explicit commitment by partners that the vast majority of short-term supply will support global access at non-profit pricing.”

The letter also calls on the Biden administration and Congress to provide “seed financing for high-quality regional manufacturing, led by the U.S. International Development Finance Corporation (DFC), to expedite expanded capacity in existing plants in regional hubs in low- and middle-income countries.”

COVAX Manufacturing Task Force

While manufacturing in the U.S. and Europe will be critical to meeting COVID-19 vaccine needs in the coming months, longer term resiliency depends on expanding manufacturing around the world.

The Coalition for Epidemic Preparedness Innovations (CEPI), WHO, Gavi, and UNICEF have taken the lead in creating a COVAX Supply Chain & Manufacturing Task Force that is planning and investing in an ambitious ramp-up of global manufacturing. Partners in the project include the Bill & Melinda Gates Foundation, International Federation of Pharmaceutical Manufacturers & Associations, Developing Countries Vaccine Manufactures Network, and BIO.

The task force has started short-term projects that are intended to coordinate supply chains and enhance existing manufacturing capacity. It is identifying and working to overcome shortages of raw materials and single-use materials.

For example, it is creating a voluntary partnership to “improve visibility of the supply of manufacturing inputs,” a precondition for optimizing allocations of scarce supplies and ensuring that COVID-19 vaccine manufacturers are not engaging in competition that increases costs and reduces capacity.

It is also seeking to play a global matchmaking role, helping manufacturers obtain supplies and setting up a voluntary scheme for matching fill/finish capacity between manufacturers internationally.

Another short-term goal, according to the task force, is “facilitating the establishment of global trade processes for free movement of single-use and raw materials, vaccine components, assay reagents, and skilled workforce required for vaccine manufacture by resolving the impact of import-export authorizations or bans and other cross-border trade-restrictions.”

The COVAX Manufacturing Task Force is also acting on longer-term plans to expand vaccine manufacturing capacity and resilience.

These including establishing vaccine manufacturing capabilities facilities in low- and middle-income countries (LMIC), starting with mRNA vaccines and later expanding to additional technologies. COVAX expects its LMIC network to begin manufacturing vaccines in 2023-24.  

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