U.S. Urged to Share a Projected 300 Million Excess Vaccine Doses

The U.S. will have 300 million or more surplus COVID-19 vaccine doses by the end of July, a stockpile that could and should be shared with countries in need to reduce uneven vaccine distribution, says former FDA Commissioner Mark McClellan and the co-authors of a new report.

McClellan, who is now director of the Duke-Margolis Center for Health Policy at Duke University, and his three co-authors highlight the great disparity in global access to COVID-19 vaccines, claiming that the wealthiest nations have taken much of the inoculation supply for themselves while poorer nations have barely gotten their vaccination programs off the ground due to a lack of funding and shots.

The U.S., for example, is likely to accumulate 300 million extra vaccine doses or more by summer, they project, assuming that the FDA authorizes Novavax’s vaccine, which is the next candidate in line, and the country sets aside a supply of doses for children.

“With U.S. support, manufacturing capacity across the five manufacturers that have advance purchase agreements is continuing to ramp up, with nearly 200 million doses per month expected in June and July and over 300 million per month by fall. This will enable timely fulfillment of updated contracts to provide vaccines for any additional U.S. needs, such as a booster dose in the fall and/or in the first half of 2022,” the co-authors said. “It can also provide significant, relatively short-term vaccine supply for global needs.”

Sharing those additional doses would require the modification of the government’s existing vaccine supply contracts to extend existing features pertinent to drugmakers, like liability protection, to the nations receiving the excess supplies. But that should be doable, the experts said, considering that the U.S. has already reportedly “loaned” 4 million doses of the AstraZeneca (AZ) vaccine to Mexico and Canada.

Because the AZ vaccine is not yet authorized by the FDA and is not being used in the U.S., other nations, including EU member states, have urged the U.S. to share its doses on a large scale. The Biden administration’s decision to loan millions of AZ doses to Mexico and Canada appears to be the first thawing of its previous position against sharing U.S. vaccine supply with other nations.

The report also offers recommendations for improving COVID-19 vaccine access around the globe in the long-term. For example, the U.S. can contribute more funding to the COVAX initiative. The most pressing need for the program, the authors said, is an additional $2 billion in funding to hit its target of vaccinating 20 percent of the populations of 92 eligible nations.

The U.S. could also lead by example by making vaccine donations or loans to specific countries. The ideal program for this would include not only vaccine supplies, but technical and managerial support and funding as well, they said.

In addition, the U.S. could engage in public-private partnerships with COVID-19 vaccine makers in order to increase manufacturing capacity. Those efforts would need to address issues across the board, the authors advised.

“An effective partnership would need to be comprehensive: governments working with the private sector would need to address trade practices that complicate access to upstream supplies, and support specialized workforce training, in addition to expediting manufacturing of safe and effective vaccines. In such an initiative, the U.S. government (and other governments) would provide part of the advance financing to ramp up the process, similar to existing contracts,” they said. “Such an initiative should aim to assure adequate supply of the raw materials and consumables needed from start to finish in the vaccine manufacturing process.”

The U.S. is highly capable of lending even more support to the COVID-19 vaccination effort, the experts said, citing its history of rapidly developing and scaling up production for multiple safe and effective vaccines that gives it unique resources for “vaccine diplomacy.”

“The capacity and knowhow that is helping the U.S. contain the pandemic provides the foundation for an effective and timely strategy to help the world do so — an essential next step to assure COVID-19 containment and recovery at home,” they said.

McClellan’s co-authors include: Michael Merson, director of the Duke Global Health Institute, Krishna Udayakumar, director of the Duke Global Health Innovation Center, and Gary Edson, co-founder and CEO of the COVID Collaborative, which brings together “leading experts and institutions across health, education and the economy to turn the tide on the pandemic.” Edson served as deputy national security adviser and deputy national economic adviser to President George W. Bush.

Read the full report here: www.fdanews.com/04-20-21-USLeadershipGlobalVaccines.pdf. — James Miessler