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Jill Wechsler is Pharm Exec's Washington Corespondent
As biopharma companies and research institutes advance the development of promising vaccines against COVID-19, policy makers and health officials have intensified deliberations on strategies for ensuring fair and equitable distribution of anticipated preventives.
As biopharma companies and research institutes advance the development of promising vaccines against COVID-19, policy makers and health officials have intensified deliberations on strategies for ensuring fair and equitable distribution of anticipated preventives. The issue is important to health authorities across the globe and has emerged as a seminal topic in the U.S. amidst growing debate over health care disparities and whether high costs will limit access to critical treatments.
To build public support for a vaccine distribution plan even before any test product gains market approval, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) have called on a special expert panel to tackle the allocation issue. At the agencies’ request, the National Academy of Sciences, Engineering and Medicine (NASEM) has formed a blue-ribbon committee of leading bioethicists, economists, geneticists and public health authorities to quickly develop a framework for priority vaccine access to assist policymakers in the U.S. and other nations achieve equitable distribution of anticipated vaccines. This project was launched July 24, 2020 with the aim of providing a final report by early October.
The NASEM panel will contribute to similar discussions by the Advisory Committee on Immunization Practices (ACIP), which regularly advises the CDC on overall vaccination policy. An ACIP COVID working group is collecting and analyzing information on pandemic vaccines under development and has held discussions and public meetings to identify high-priority groups for initial vaccination. There will be further open public meetings in August and September, and the ACIP committee will collaborate with the NASEM panel to avoid confusion and build public confidence in their recommendations.
The resulting distribution framework aims to identify first tier vaccine recipients as well as populations that should be added as more vaccine becomes available. Individuals at higher risk will include those in higher age groups, with underlying health conditions, engaged in high-risk occupations, affected by racial and ethnic disparities, and in hard-hit geographic locations. The experts also will consider how best to communicate the allocation recommendations to promote a sense of equity and to mitigate vaccine hesitancy. The NASEM panel is holding its second meeting Aug. 7, moving quickly in order to issue a draft report by early September and then final recommendations by early October. The very tight timeline is designed for the panel to present its framework in time to have an impact.
At the opening meeting of the NASEM expert panel in July, NIH director Francis Collins directed the group to consider the needs of individuals at highest risk of complications from COVID-19 and of essential workers in setting a distribution policy well in advance of having an approved vaccine. Collins also proposed early access for participants in late-stage vaccine clinical trials who receive a placebo, instead of treatment. Whether there are 10 million or 100 million doses available early on will determine how far down the priority list health authorities can go, he explained, but with taxpayer money funding vaccine manufacturing ahead of time, the aim is to have millions of doses ready to go when authorities determine that one or more vaccines are safe and effective.
Even with an agreed-on plan for equitable access to vaccines, federal and state agencies and industry face a monumental task of transporting, distributing and administering millions of vaccine doses as fast and as efficiently as possible at the appropriate time. A serious complication is that there may be more than one approved vaccine, with products carrying different indications and dosing protocols. Delivery requirements will vary depending on product temperature, storage and handling requirements. With some vaccines requiring two doses, it will be important to keep track of who needs a second dose and when and where. Systems also are needed to track and report adverse events, as well as overall immune response.
While the CDC normally manages vaccine distribution to state agencies, especially for children, uncertainty has been generated by talk of the military stepping in to handle main logistics, as proposed by the administration’s Operation Warp Speed initiative. State and public health officials are wary of federal pandemic planning efforts so far, given the lack of coordination and effectiveness in distributing COVID-19 test kits and personal protective equipment to health care providers and facilities. Shortages continue in those categories, and in supplies of those medicines that have demonstrated some effectiveness in treating sick patients.
The National Governors Association has advised state officials to start planning now for vaccine administration efforts, but acknowledges that uncertainty over who will be in charge complicates such efforts. Meanwhile, vaccine manufacturers will be looking for information on where to ship vaccines when available, initially for emergency use and more widely following product approval. That will require decisions on priority populations and locations to receive early vaccines, which hopefully will emerge in time to support efficient distribution efforts.