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Expert Meeting Highlights Key Challenges in COVID-19 Vaccine Development

A recent discussion, focused on ensuring sufficient investment and interest in vaccine development for the next infectious threat, brought to light the incredible complexity involved in developing, manufacturing and distributing a vaccine on a massive scale in an equitable way.

Vaccine

More than half a year into quarantine, COVID-19 has altered nearly every aspect of our everyday lives and continues to dominate the news cycles daily. One area of particular interest is that of a COVID-19 vaccine, a key factor in ameliorating the current threat of the virus and returning our lives to some semblance of “normalcy.” That possibility has driven my fixation, and that of others around the world, on news of the hundreds of vaccines in development, the progress and setbacks of clinical trials underway, and the anticipated timing for the vaccine’s availability.

The COVID-19 vaccine, once approved, will most likely be made available to essential workers first, with a vaccine for the general public not available until late 2021. Nevertheless, it’s tempting to envision a “finish line” to this cycle of uncertainty. And yet, any envisioned distant finish line is an illusion. While we are currently laser-focused on developing and distributing a COVID-19 vaccine, it is equally important, if not incredibly daunting, to begin preparing now for the next infectious threat. What incentives do we need to have in place to ensure sufficient investment and interest in vaccine development, beyond COVID-19? That question was the leading motivation behind an invitational discussion hosted by AcademyHealth’s Research Insights project, supported by the Agency for Healthcare Research and Quality (AHRQ).

The virtual meeting brought together research and policy experts to review existing research on vaccine development, manufacturing, and distribution, including financing mechanisms and policies to promote equitable access to vaccines both in the United States and abroad. While the focus of the discussion, which is summarized in an issue brief, was on learning from the current pandemic to prepare for the next threat, the meeting discussion also highlighted the complexity involved in developing, manufacturing and distributing a vaccine on a massive scale in an equitable way.

A few key challenges and opportunities stood out to me from the presentations and discussion.

The way out is through, together.

The virus’ spread demonstrates how interconnected we are at a global level, and this interconnectedness holds true for the vaccine, as well. One participant in the recent meeting noted, “We're not safe unless everybody is safe, and so we've got to talk about vaccines for the world, not just for the U.S., and we have to talk about vaccines for high-, middle- and low-income countries.” The United States initiated Operation Warp Speed, a U.S.-focused effort that aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. Yet, it’s clear that even if the operation can achieve its aims, the threat of COVID-19 will remain until vaccines are available and distributed around the world equitably. Other public-private partnerships, including those led by the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance, are leading the global collaboration efforts for vaccine development, production and access.

Adding further complexity, once an effective vaccine is developed, it has to receive regulatory approval. Then, it will need to be manufactured and distributed at a scale never before attempted—potentially billions of doses. Each dose will require a glass storage vial and a syringe, which given the demand, may be in short supply. As an economist at the meeting noted, “Having lived through the last few months, none of us would like to bet our lives on the supply chain working properly…If we can't make masks, how are we going to be sure we can make other things?” Additional research is needed to help policymakers ensure global supply chains are up to the challenge of producing billions of doses of vaccines as efficiently as possible. It’s clear that global collaboration is key.

Inequities laid bare.

The pandemic has laid bare the inequities that exist in the United States as a result of systemic and structural racism and discrimination. People of color disproportionately work in essential roles, limiting their ability to work remotely and increasing their risk of exposure to the virus. According to a recent analysis by the Kaiser Family Foundation, people of color fared worse than white patients at every stage of the COVID-19 pandemic, including higher rates of infection, hospitalization, and death. Equitable access to the vaccine is paramount to address these growing inequities.

But vaccine acceptability, particularly among communities of color, may pose an additional challenge to equitable distribution and access. Differences in people’s willingness to get a COVID-19 vaccine also can impact equity. A May 2020 Pew survey found that Black Americans are less likely than white and Hispanic Americans to say they would get a vaccine. The survey findings are unsurprising given the historical legacies of abuse/maltreatment that Black Americans have experienced in the U.S. health care system. That legacy dates back to slavery, the Tuskegee experiments, and is further exacerbated by the current experience with the COVID-19 pandemic. Among the recommendations to support equitable access, a physician researcher at the meeting noted the importance of identifying partners, such as trusted community organizations beyond traditional sources in health care and government, to help distribute the vaccine where people live. The physician researcher also noted the importance of public campaigns, led by trusted messengers, to overcome vaccine hesitancy. Recently, the National Medical Association, a national association of African American physicians, has formed an independent, expert task force to review government approvals of COVID-19 drugs and vaccines and make sure decisions are based on sound science.

The physician researcher also noted, “Vaccines serve a dual purpose—they save lives and they interrupt disease transmission, so the first question in designing policies to promote equitable access is to identify the objective. Are we seeking to protect lives? In which case, our top priority should be the elderly and those with chronic conditions, who we know are more susceptible to the virus. Or is the objective to interrupt transmission? In which case, we would prioritize allocation of the vaccine for our front-line or essential workers or groups that we know may be super spreaders.” A federal advisory panel convened by the National Academies of Medicine recently released a framework to guide the equitable allocation of the vaccine in the United States. Their initial guidelines indicate a four-phased approach to vaccine distribution when the vaccine supply is limited, starting with front-line health workers and first responders, followed by people with underlying health conditions that put them at high risk, as well as older adults in dense living settings.

When, not if.

It’s difficult, and uncomfortable, to envision living through another pandemic while we are still in the midst of the current one. But, if recent experience has shown us anything, it’s not a question of if another pandemic will arise, but when. As one participant in the meeting noted, “The whole field [of preparedness] is characterized by repeated cycles of panic and neglect, and panic and neglect, and each time, we kind of say never again, and then things happen again.”

There have been painful lessons from the COVID-19 pandemic about preparedness, response, ensuring adequate funding and investment upfront, and confronting the legacies of systemic and structural racism that lead to inequities in health outcomes for people of color. There has also been, as one preparedness expert at the meeting noted, an “incredible brain trust in academia, in foundations, and the private sector” that has risen to document, examine, and learn from the current pandemic to inform current and future decisions. Going forward, it will be critical to maintain not only this brain trust, but the preparedness infrastructure, investment, and incentives for new vaccine development that will be needed when the next infectious threat emerges.

Staff

Megan Collado, M.P.H.

Director - AcademyHealth

Megan Collado is a director at AcademyHealth, where she manages a number of Robert Wood Johnson Foundation gra... Read Bio

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