Amidst a charged polarized political landscape, concern for the COVID-19 pandemic extends beyond the task of developing effective and safe therapeutics and vaccines. Once proven therapies and vaccines emerge, ensuring widespread access and acceptance by the public may turn into a daunting task. And given the competition among nations to garner sufficient supplies for their populations—even with the recognition that global cooperation is needed to climb out of this public health and economic mess—herd immunity through an effective and safe vaccine is the goal.
Adding to the difficulty in the United States is the mixed messaging from government institutions like the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) charged with informing the public about the safety and efficacy of agents and vaccines. With anti-vaccine sentiment already a challenge faced in the US, lacking a coherent, unified message from these institutions an added barrier to providers and others who may need to convince their patients and the public at large of the critical need for vaccination.
Health Affairs hosted a webinar on August 24, 2020 in which a panel of experts spoke about innovations underway to meet the therapeutic and preventive needs to adequately address COVID-19 and SARS-Cov-2. Among the key issues discussed was the need and challenge of ensuring equitable access to the vaccines and therapeutics that make it through the pipeline to the public.
A major theme emerging from the webinar was the critical need for national and global collaboration in terms of drug and vaccine development, manufacturing, and, importantly, distribution. Without such collaboration, even the best of drugs or vaccines won’t stop the virus.
“The advent of vaccines to prevent and drugs to treat COVID-19 is meaningless without a well-articulated strategy to ensure these products are safe, effective, affordable, and accessible to all,” said Rena M Conti, PhD, associate professor, department of markets, public policy, and law, Questrom School of Business, Boston University. “Equity of access must go hand-in-hand with new product development.”
Equity of Access: Repurposing Generics
Dr Conti spoke during the webinar on the value of repurposing drugs for COVID-19 to ensure affordability and access. Recently she and her colleagues undertook a review of all therapeutics in development for the treatment of COVID-19 and found that out of nearly 300 drugs in development, 138 are older generic drugs of which 50% are deemed by the World Health Organization (WHO) as essential for treating other chronic diseases globally. To date, 29 of these agents are in phase 3 clinical trials and are showing a positive signs of efficacy.
“These drugs have established safety profiles and this may lead to faster, cheaper trials [to assess their efficacy for COVID-19],” said Dr Conti. Not only will this save critical time in getting an effective agent into the hands of doctors, but the cost will be much lower than a novel agent.
“It costs approximately $300 million to bring a repurposed drug to market representing a savings of 85% to the $2.6 billion for a new drug if the cost of failed projects is taken into account,” said Dr Conti.
Unlike novel agents—many of which carry high price tags, running into the thousands of dollars per treatment course making them potentially unaffordable to some patients—lower cost repurposed agents permit wider access and affordability.
The United States is behind on this, not only by focusing on funding clinical trials of novel agents but by distractions of unproven agents such as hydroxychloroquine that have used up the limited pool of eligible patients needed for conducting clinical trials.
All the clinical trials on repurposed agents are currently being conducted overseas. “This effectively forecloses Americans from learning about the use of these drugs to treat COVID-19 in real time,” Dr Conti said. “We need an all-in strategy to address COVID-19. Not investing in understanding how and when to use these drugs does Americans a great disservice and hampers our ability to get back to our lives.”
Dr Conti and colleagues recently published a white paper titled, “Generic Drug Repurposing for COVID-19 and Beyond” in which they lay out a three-part plan on how to advance a low-cost, high-impact response to COVID-19 and future pandemics.
The white paper offered the following suggestions among others:
“Public agencies will fund studies aimed at identifying promising drug repurposing targets and coordinate clinical trials of promising candidates alone and in combination with new therapeutics. Government will also contract for the manufacturing of promising candidates, paying costs plus a premium to ensure sufficient capacity for the exploration of new uses without undercutting the adequacy of supply for existing uses.”
Equity of Access: Vaccine Distribution
Once a vaccine becomes available, a major challenge will be to target populations where the vaccine is most needed. On August 26, 2020 the CDC proposed guidance based on recommendations from the Advisory Committee on Immunization Practice (ACIP) on distribution within the US prioritizing health-care workers, essential personnel, and vulnerable Americans.
Among vulnerable populations are people of color who are disproportionately affected with severe COVID-19, which can be fatal. During the Health Affairs webinar, Garth Graham, MD, vice president and chief community health officer, CVS Health, underscored the challenge of ensuring these populations receive the vaccine once one becomes available. “A lot of early survey data show a high antivaccine sentiment among minorities and that speaks to the history that minority communities have had with the health care system and issues of mistrust going all the way back to the Tuskegee experiments.”
Recent data from the Pew Research Center shows that 44% of Black adults would not get the vaccine if available today. Further data show the significant disparities that exist across race and geographical areas in the US in people’s willingness to accept a COVID-19 vaccine.
To help reach these populations, Dr Graham explained a four-pronged strategy: (1) mobilize community partners; (2) launch targeted specific health messages using trusted sources; (3) have sites and locations for vaccination in the community; and (2) engage health care providers.
To that last point, Dr Graham emphasized that trust is critical in reaching these populations. Data on flu vaccinations, highlight the importance, particularly among Black communities, of trusting the person who talks to them about and delivers the vaccine. “Providers who are in contact with communities are key to educating communities about the vaccine,” he continued, adding that education needs to start now and should be a part of counseling patients about vaccines in general.
Overall, he stressed the need for strategies that allow increased access, particularly for communities of color. Along with the CDC/ACIP suggested guidance on distribution, further guidance was released on September 1, 2020 by the National Academies of Sciences, Engineering, and Medicine along with the National Academy of Medicine. Although minorities are not listed as a priority group for vaccination, the guidance does prioritize people with vulnerabilities associated with minority communities such as populations with underlying medical problems.
Gavin Mark Yamey, professor, practice of global health, Sanford School of Public Policy, Duke University, emphasized the need to prioritize vaccine distribution to high-risk, vulnerable populations including people of color as well as the incarcerated population. “In the US today, all ten of the worst outbreaks are in jails and prisons,” he said.
Mr Yamey cautioned rushing vaccine development, voicing what many are concerned about—approval of an unsafe vaccine that would not only be dangerous to the public but a huge setback, particularly given existing antivaccine sentiment.
“A key to addressing vaccine hesitancy is to ensure that everyone in the health professionals community feels it is safe and effective,” Mr Yamey said. “Research shows that when health providers express confidence, this influences community decision-making.”
Angela K Shen, ScD, MPH, visiting research scientist, Vaccine Education Center, Children’s Hospital of Philadelphia, and Captain (Ret.), US Public Health Service, also spoke on distribution challenges and the well-established vaccine distribution and logistics network in the US for getting vaccines to providers, pharmacists, hospitals, and health systems.
“Building on the assets of the current immunization delivery system will be important to leverage,” she said, such as increasing vaccination services with providers who see adults.
Ms Shen underscored the need to rely on immunization information systems, or registries, for tracking vaccine products and the people receiving them. “This is essential as most of the vaccine candidates will require more than one dose and these vaccines are not interchangeable.”
Drawing on lessons learning during H1N1, she said it will be critical for the agencies responsible for distributing the COVID-19 vaccine to clearly articulate detailed plans so states and localities can adapt their plans. “This is one clear lesson from H1N1 as the supply of vaccine and associated supplies fluctuated greatly.”
As for providers, Ms Shen encouraged listening to patients about their concerns about a COVID-19 vaccine as many of their concerns may not be addressed by presenting facts. “Education is not sufficient to change minds,” she said, suggesting the need for deeper understanding of a person’s reluctance to get vaccinated that may not be alleviated by data.
“Concerns about vaccines are very specific to vaccine types,” she explained. “For COVID-19 vaccines, many are concerned about the speed in which development is occurring, which may be quite different from concerns about other vaccines like flu or certain childhood vaccines.”
Equity of Access: Collaborate
Given the global reach of this pandemic, only a global response will bring it to a close. For that to happen, effective and safe therapeutics and vaccines need to be developed and distributed strategically and equitably. “To reach herd immunity worldwide, and thus bring the pandemic to an end, a safe, an effective vaccine must be delivered to all countries,” said Mr Yamey, who stressed the need for nations to participate in COVAX Facility.
Lead by three organizations (the Vaccine Alliance, the WHO, and the Coalition for Epidemic Preparedness Innovations or CEPI), COVAX aims to distribute two billion doses of vaccine to all participating nations by the end of 2021. It is estimated that this should be enough to vaccinate 20% of the populations (ie, health workers, high risk populations) of these nations. To date, 172 countries have joined this effort, 80 higher-income countries and 92 low-and middle-income countries, according to WHO.
As of September 1, the White House and Trump administration issued comments stating that the country will not be participating in the COVAX initiative or further vaccine initiatives organized by WHO.