Even more distressing has been the outcry by many American citizens voicing their mistrust of eventual SARS-CoV-2 vaccines that are being rapidly developed and studied as part of Operation Warp-Speed (e.g.- New York Times article– Accessed November 6, 2020).  While anti-vaccination sentiment is not uncommon in our country, and around the world, this most recent episode focused on COVID-19 vaccines is acutely grounded in the perception of political interference with the scientific process, as well as remembered abuses of American citizens of color, particularly African-Americans (More than Tuskegee: Understanding Mistrust about Research Participation – J Health Care Poor Underserved. 2010 Aug; 21(3): 879–897).  Ultimately, this mistrust may prove to be a losing proposition for African-Americans, Hispanic/ Latinos, and Native American Indians since these communities have mortality rates that are 2.2 times (African-Americans) to 1.5  times ( Hispanic/ Latinos, and Native Indians) that of their Caucasian counterparts (See Image 1).  Vaccinations offer an opportunity to defend against the critically deleterious health outcomes that may be associated with natural human infection from SARS-CoV-2.  To refuse the SARS-CoV-2 vaccine certainly increases the chances of succumbing to serious long-term health complications, or even death.

Communication from the African-American Scientific Community  (Enhanced Transparency)

Recognizing the potentially negative impacts of perceived interference in the scientific process to create these vaccines, multiple national organizations have created ad hoc committees to provide oversight into the clinical research and manufacturing practices of the companies and entities developing the vaccines. The American Medical Association directly engaged the US Food and Drug Administration (FDA) by sending a letter encouraging increased transparency and communication into COVID-19 vaccine development.  This engagement seeks to assuage the fears of the public that the SARS-CoV-2 vaccine development is rushed and politicized, which increased the public’s concerns that the vaccines may be unsafe or not effective.

In thorough acknowledgement of the profound historical mistrust from African-American communities with scientific clinical research, the National Medical Association (NMA) formed an interdisciplinary  COVID-19 Task Force to directly engage the FDA, as well as the pharmaceutical companies involved in COVID-19 vaccine research and development. The task force includes NMA physicians who serve on the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), Infectious Disease Society of America, Pediatric Infectious Disease Society, and the CDC Health Equity Workgroup. Also included are pharmacists, nurses, and epidemiologists all with the goal of reviewing any SARS-CoV-2 vaccine developed will be safe and effective for all American citizens, and particularly those of color, that choose to receive the vaccine.

The goal of the NMA COVID-19 task force will be to provide timely recommendations to physicians and people in communities about any Emergency Use Authorizations (EUA) and eventual approvals by the FDA for COVID-19 vaccines and therapeutics presently being evaluated in clinical trials.  Next, effective and accurate communication can be provided directly to communities of color about the safety end effectiveness of these vaccines through their trusted health providers.  Hopefully, this will overcome the mistrust that many from the mentioned communities are feeling, and thus give themselves a chance to prevent becoming infected with this terrible virus.

Different Types of Vaccine Mechanisms for Antibody Stimulation

While people in communities may be waiting for “A Vaccine”, actually there are multiple companies developing several types of vaccines with different immunological mechanisms of action.  A small number of companies are in Phase II or III in their clinical research process.  In actuality, there are over 200+ COVID-19 vaccines in development worldwide.  Almost 40 are in some phase of clinical trials. The general perception from the public is that vaccine development just started once the COVID-19 pandemic occurred.  In truth,  serious coronavirus vaccine development began when the original SARS was prevalent in 2002-04 (Tripp RA,  et al.  “Monoclonal antibodies to SARS-associated coronavirus (SARS-CoV): identification of neutralizing and antibodies reactive to S, N, M and E viral proteins” Journal of Virological Methods. 128 (1–2): 21–28 , Sept 2005. doi:10.1016/j.) Once this current COVID-19 pandemic began, world-wide researchers had a 15-year history of studying coronavirus vaccine platforms.

For illustrative purposes, I show only four companies with SARS-CoV-2 vaccine clinical trials in the United States (See Image 2); I have no financial relationships with any of the companies shown.  People receiving COVID-19 vaccines in the near future must be notified, in lay terms, of the type of vaccine being provided, the company, and generally how it will produce immunity.  Two of the vaccines utilize messenger RNA platforms to elicit an antibody-producing immune response in the recipient. This is a new vaccine technology, and can be manufactured relatively quickly when compared to the other vaccines.  It is expected that the two companies that produce this version of the SARS-CoV-2 vaccine, Moderna and BioNTech/Pfizer, will file their Phase III results with the FDA first, and likely seek Emergency Use Authorization approval before the end of 2020.  To date, the messenger RNA vaccines appear to be safe in clinical trials.  The other companies in Image 2 are likely to file for FDA approval in early 2021.  It should be noted that of the companies shown in Image 2, only BioNTech/Pfizer did not receive any public money from the US Government to fund their research.

For many of the companies, mass manufacturing of their vaccines began in summer 2020 in order to get an early boost in producing enough doses for large scale distribution once approved.  All of the research AND manufacturing processes are certain to be scrutinized by the organizations mentioned earlier (NMA and AMA) for overall safety and effectiveness of the vaccines. These companies have taken the financial risk of their vaccines not enduring the rigor of clinical trials, which could in turn lead to their product not being approved by the FDA.

Equitable Distribution of Manufactured Vaccine Product

On the opposite side of the mistrust of COVID-19 vaccines, there are many health-focused and community organizations that will be monitoring and advocating for the equitable distribution of the vaccines once they have been approved by the FDA.  Some lead organizations are the National Academies of Science, Engineering, and Medicine.  They formed a group called the Committee on the Equitable Allocation of Vaccine for the Novel Coronavirus, which issued a guidance document that provided a four-phase allocation plan for COVID-19 vaccines. The goal is to account for the most vulnerable and most impacted individuals and communities affected by the pandemic (See Image 3).  The earliest vaccine allocations will most likely be provided to front-line healthcare workers, and those individuals at highest risk for severe morbidity and mortality (underlying health conditions (chronic included) and older adults living on congregate living conditions).  African-Americans carry a disproportionate share of chronic cardiovascular conditions such as diabetes and hypertension, greatly increasing their mortality potential once infected by SARS-CoV-2.  Subsequent allocations should be provided to a larger majority of Americans in numerous components of society (teachers, essential workers, etc), and those with moderate health conditions.  The next allocations shall go to young adults, lower transmission-risk employees, and finally all persons residing in the United States (National Academies of Sciences, Engineering, and Medicine 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press).  Again, input and vigilance from organizations such as the National Medical Association and the American Medical Association will be critical to insure that all Americans that choose to be vaccinated will have equitable access.

Taking the Opportunity to Live a Quality Life

In my previous article “Coronavirus Vaccines – ‘Trust, But Definitely Verify!‘”, the attempt was made to convey that COVID-19 vaccination offers the best opportunity to significantly bend the arc of poor health outcomes caused by SARS-CoV-2 in a more positive direction.  The metric of measuring deaths from COVID-19 is not the only concerning statistic, as potentially hundreds of thousands of infected patients may find themselves coping with long-term health challenges well after their infectious state has resolved ( Rubin R. As Their Numbers Grow, COVID-19 “Long Haulers” Stump Experts. JAMA. 2020;324(14):1381–1383). With the known possible negative effects on multiple organ systems in the human body (See Image 4), individuals should make every attempt to protect themselves against this virus through vaccination.  Additional and continual communication with the public will certainly be necessary to achieve this public health outcome.  In order to achieve this level of trust, the FDA must be overly cooperative and transparent with the NMA, the AMA, and the public during the vaccine approval process once they are adequately proved to be safe and effective for the majority of patients that receive them.  Healthcare providers across the country, as they have done and will continue to do throughout the pandemic, stand ready to serve the public health interests to maintain as healthy a society as possible.

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Greater than 198,000 Americans have died as a result of being infected by the novel Coronavirus (SARS-CoV-2) as of late September 2020.  The first confirmed case in the United States occurred on January 20, 2020 ( N Engl J Med 2020; 382:929-936). According to the University of Washington Institute for Health Metrics and Evaluation (IHME), the projected number of Americans that may die from Coronavirus disease (COVID-19) by November 1, 2020 is greater than 229,000 (covid19.healthdata.org Accessed Sep 20, 2020).  Unfortunately, the IHME model has proven to be fairly accurate during the duration of the national pandemic.  As for the racial/ethnic mortality demographics of COVID-19, the largest percentage of the cases have been people of color, and in particular African Americans. (Yancy CW.  JAMA. 2020;323(19):1891–1892; Journal of National Black Nurses Association. 31(1):1-12, 2020 Jul).  From information posted on covidtracker.com (a link connected to CDC.gov), Blacks are 2.4 times more likely to die than Whites; Latinos and Native Indians are dying at 1.5 times the rate (See Image 1).  This disproportionate effect on racial and ethnic American populations further spotlights the stench of health inequities that have befallen our country for decades, if not centuries (Smedley BD, Stith AY, Nelson AR, eds. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. : National Academies Press (US); 2003).  In the midst of the current SARS-CoV-2 pandemic, this is a moment that now demands that the entire healthcare system – (patients, healthcare providers and institutions, public officials, and insurers) – all implement actions to drastically slow the death rate and the potentially lasting deleterious health effects of this virus.

During the past several months, a focus on vaccine development to combat the SARS-CoV-2 pandemic has reached a feverish pitch.  The United States’ enhanced SARS-CoV-2 vaccine creation initiative, known as Operation Warp Speed, is focused on public-private partnerships with biotechnology pharmaceutical companies for COVID-19 vaccine development. As the name implies, the goal of this initiative is very rapid vaccine development.  Commonly, new vaccine development can take anywhere from 5 – 10 years; the effort here is to develop a COVID-19 vaccine in approximately 9 months.  While this seems quite expedient, much of this work actually began 15 years earlier during the original SARS-CoV outbreak in 2005. SARS-CoV (2005) was highly lethal, but not nearly as infectious (WHO Consensus document – (SARS) – 2003).  While the SARS-CoV (2005) vaccine development initiatives greatly slowed during the past 15 years, the scientific platforms that were developed helped launch the current world-wide race to create a vaccine.  When we add in predictive analytics, supercomputing, and advanced manufacturing practices, it becomes understandable how this may be achieved.  It also becomes quite apparent why there may be heightened skepticism by the American general public concerning the safety of a vaccine developed this quickly.  This skepticism is also quite elevated in the communities of color.  Many individuals may ask themselves “Do I risk receiving a vaccine, or risk catching the virus?”  With the deadly potential for COVID-19, or even the risk of long-term bodily injury by this novel Coronavirus, I implore everyone to strongly consider receiving an eventually approved vaccine that has undergone the appropriate FDA approval process.  Here are my reasons.

Updates on The Current Coronavirus Research Clinical Trials

There are SARS-CoV-2 vaccine clinical trials emerging across the United States, and the globe.  To date, no deaths directly attributed to the vaccine have been documented in the current clinical trials; there have been mostly mild to modest adverse effects documented for patients during the clinical trials (pain at injection site, elevated temperature, etc).  These conditions were effectively managed with acetaminophen, and the duration of symptoms were short.  More serious adverse effects have been noted in several phases of the trials; the numbers of these more serious effects have been very low when compared to the number of people that have received the test vaccinations worldwide.  Continual reviews of possible adverse effects for all companies administering vaccine in clinical studies are conducted by their respective independent Data and Safety Monitoring Boards (DSMB) to determine if these challenges were due to the vaccine.  DSMBs work independent of the companies to avoid conflicts of interest with pharmaceutical product testing during clinical trials.  With tens of thousands SARS-CoV-2 vaccine doses having been given worldwide thus far in clinical trials, there is growing observational evidence that the vaccines are at least not producing widespread serious adverse effects.  Now, more clinical trial research is needed to confirm the safety profiles of all of the various types of SARS-CoV-2 vaccines being developed, while simultaneously producing evidence that they will protect the user from developing COVID (Coronavirus disease).

Taking a Chance to Live – Time to Engage in the Solutions

Early in the onset of the COVID-19 pandemic, progressive respiratory failure was the most known and recognizable clinical manifestation of COVID-19. Other very noticeable bodily effects began to emerge as the virus continued to spread throughout the globe.  Cardiac disorders (mycarditis- inflammation in the heart; blood clots; heart attacks) have surfaced; neurological disorders (loss of smell and taste; mood disorders; headaches and dizziness); clotting disorders (blood clot development in the lungs and brain; small vessel clots); and gastrointestinal disorders (diarrhea, abdominal pain; nausea/ vomiting) among other disorders. (See Image 2) As the image shows, COVID-19 is far more than “just” a respiratory disease, and can produce very serious illness, bodily damage, and potential death of the infected individual.

Given that the beginning of SARS-CoV-2 has primarily occurred over the past seven months, scientists and clinician researchers have not had enough time to follow patients to see if these medical conditions will completely resolve in all patients.  Persons infected by SARS-CoV-2 that have additional chronic health conditions (high blood pressure, diabetes, obesity, etc.) are at significant risk to experience the most severe health problems.  Because of significant disparities in healthcare, including lack of access to quality healthcare and poorer social determinants of health (factors include: education, food access, neighborhood environment, socioeconomic status, etc.), African-Americans, Latinos, and American Indians (Image 1)  have been most negatively affected (See Coronavirus And Health Equity- Again This (Too) Is Predictable).   The potential for death following SARS-CoV-2 infection is elevated in these racial/ ethnic groups, despite the expanding use of therapeutic treatments (medications).  And with the continued re-opening of the American economy, there is no reason to expect that infection rates will go down in our communities of color.  More must be done to protect the most vulnerable among us.

I am urging individuals from Black/African-American, Hispanic/Latino, Native American, Asian Indian, and any other identified communities of color to participate in the clinical trials for SARS-CoV-2 vaccines.  Before widespread distribution of any vaccine can be achieved, we must first gather credible data and information about the safety and efficacy of these vaccines.  This can only be achieved through clinical research.  While mistrust of clinical research in all of these communities has valid historical reason to exist, we must actively participate in the process to transparently gather and distribute all of the safety and efficacy data that is owed to every individual in all communities that seek to have such information (Scharff DP et al, More than Tuskegee: understanding mistrust about research participation. J Health Care Poor Underserved. 2010;21(3):879-897). Clinical researchers such as myself must be ever-present to watch and protect people from all communities.  We must be available to help the restoration of trust in not only the clinical trial process, but in the healthcare system overall. Trust the Process, But Definitely Verify All Actions with Accountability and Transparency!

We are all faced with a foe in SARS-CoV-2 that has already proven to be deadly, and may leave the afflicted with long-term health ailments.  As I mentioned in a recent community webinar, the most fundamental task we must attempt to accomplish each day is to stay alive.  To live as productive a life as possible.  And to be present for our children and loved ones as they proceed into a world that is changing more rapidly than our ability to keep up with it.  This Coronavirus does not know color or ethnicity; it doesn’t know political affiliation; it doesn’t know rich or poor.  It only knows its eventual victim as being a human being.  We owe it to ourselves to fight back against it.  Please Join Us in the battle against this virus. (See WE-CARE for more information in Florida)

Part II of Coronavirus Vaccines – “Trust, but Definitely Verify!” will follow shortly.  There I will discuss the different types of Coronavirus vaccines presently being developed and studied, along with the necessity to hold all companies and our government accountable for equitable distribution of the vaccine to all communities once they are proven worthy for human application.  Stay Tuned, and Stay Safe!!

Image 1. (Adapted from covidtracking.com/race – Accessed 9/20/2020)

Image 2 (Adapted from the journal Nature Medicine)