Rapid manufacturing and distribution of a COVID-19 vaccine will rank as one of the most challenging U.S. government initiatives ever undertaken, though it can successfully happen with aggressive planning, management, and funding, concludes a newly released report that includes a powerful indictment of the Trump administration’s current efforts.
Experts think two doses of vaccine will be needed, requiring the manufacturing, financing, distribution, and administration of 462 million doses to achieve herd immunity and 660 million doses for the entire U.S. population, according to the Center for American Progress (CAP), the independent, nonpartisan policy institute that on July 28 released the report, A Comprehensive COVID-19 Vaccine Plan.
“Unfortunately, the Trump administration’s effort so far has been plagued by needless delays, questionable decisions, and a lack of planning and transparency,” wrote report authors Topher Spiro, CAP’s vice president of health policy, and CAP Senior Fellow Zeke Emanuel. “To date, the administration has not released a comprehensive vaccine plan.”
The CAP report authors said that “a massive coordinated effort” at both the federal and state levels is needed to produce a vaccine.
And challenges remain despite the Trump administration in May establishing Operation Warp Speed, which coordinates the component agencies of the U.S. Department of Health and Human Services (HHS), the U.S. Department of Defense, private industry, and other federal agencies to develop, manufacture and distribute COVID-19 vaccines quickly, according to the report.
For instance, Operation Warp Speed currently has selected five vaccines: the Moderna (RNA), Pfizer (RNA), Johnson & Johnson (nonreplicating vector), the Oxford/AstraZeneca (nonreplicating vector), and the Novavax (protein) that are eligible for federal support of clinical trials and manufacturing. Yet the CAP report authors pointed out that Operation Warp Speed did not consult the National Institutes of Health’s Accelerating COVID-19 Therapeutic and Interventions and Vaccines committee, a key group of scientific experts.
Additionally, the five selected vaccines use three different technologies, with just one of them using a technology that a licensed vaccine uses (the Novavax vaccine), wrote Spiro and Emanuel.
“Since the U.S. is currently relying heavily on vaccines that use unproven technologies, it is critical that additional vaccines that use traditional technologies be developed as a hedge,” they wrote.
The portfolio of U.S. vaccines must be diversified to ensure that at least one vaccine is safe and effective, explained Spiro and Emanuel.
“Moreover, it is unlikely that the first vaccine authorized by the FDA will be the best vaccine, and some vaccines may be inappropriate for certain populations,” the report authors wrote. “If the virus becomes endemic and immunity wanes, several vaccines will be needed.”
Widespread vaccination faces many challenges and could take many months, Spiro added in a statement, saying the CAP report “lays out a clear roadmap for the federal government to scale and coordinate manufacturing, boost purchasing efficiency, and ensure the distribution of a vaccine saves as many lives as possible.”
Specifically, the report summarizes what the federal government should be doing right now to safely facilitate production of a vaccine as fast as possible.
Among several key recommendations in the report are that the Executive Branch and Congress accelerate the development of alternative vaccine technologies and map the nation’s manufacturing and fill-finish capacity, including manufacturing capacity for brewing equipment.
The federal government also should invest up to $400 million to retrofit four existing facilities for the production of 50 million doses per facility; $100 million to expand the capacity of manufacturers of brewing equipment; up to $1.4 billion to build two new manufacturing facilities; an additional $70 million to expand manufacturing capacity for syringes and needles; and appropriate $20 billion for the purchase of COVID-19 vaccines and related supplies for the U.S. population, $10 billion for community vaccination clinics, and $1.5 billion for the cost of administration for uninsured individuals, according to CAP recommendations.
Another $7.2 billion should be appropriated for the World Health Organization’s international financing mechanism for low- and middle-income countries, while also securing commitments from U.S. allies, recommends CAP.
At the same time, the U.S. government should issue guidelines for states on how to target distribution and operationalize targeting and use the Defense Production Act to coordinate vaccine manufacturing capacity and supply chains.
Toward releasing a comprehensive vaccine plan, the government also should:
- Map the nation’s manufacturing capacity for vaccine supplies and materials, including vials, syringes, needles, stoppers, adjuvants, and cold storage;
- Expand the supply of more rapid sterility and potency tests;
- Utilize the Vaccines for Children Program as a model to bulk purchase 660 million doses;
- Contract with a technology company to upgrade the Vaccine Tracking System;
- Partner with state health departments and the private sector to establish 7,300 community vaccination clinics; and
- Plan a massive vaccination campaign by recruiting medical experts, sports stars, celebrities, and community leaders and partnering with grassroots organizations and medical organizations.
To develop CAP’s vaccine plan, Spiro and Emanuel wrote that they interviewed representatives of vaccine manufacturers, pharmacies, manufacturers of vaccine supplies, and other experts and reviewed all publicly available information.
“But we were limited in the information that we could obtain because we are not government officials, and some information is proprietary or confidential,” they wrote. “Accordingly, policymakers should use this assessment as a guide to seeking additional information and to inform planning efforts.”
The report is available in its entirety here.