October 29, 2020
COVID-19 Vaccines & Clinical Trials: The First Step Toward Being Well Is Being Educated
Since the outbreak of COVID-19, millions of Americans have been in search of the best ways to protect themselves from contracting and spreading the virus. Over the course of nearly seven months, that has meant following their local government’s shelter in place guidelines, practicing social distancing, wearing masks, and taking other precautions to remain healthy.
As government officials and health advocates educate and urge people to take the health crisis seriously, researchers and medical professionals are working diligently toward solutions to flatten the curve. One potential preventative tool is a messenger RNA (mRNA) based vaccine candidate (BNT162B2) being developed by Pfizer in partnership with BioNTech. Critical to the success of any vaccine is doing the work that must be done to encourage people from all communities, particularly underserved communities, to consider the value proposition of taking the vaccine if it is authorized or approved by the FDA as safe and effective.
Two of the women doing this work are Judith Absalon, M.D., MPH, FIDSA, Senior Medical Director in Vaccines Clinical Research and Development, and Dara Richardson-Heron, M.D., Chief Patient Officer at Pfizer. Dr. Absalon is directly involved in the clinical development of the vaccine candidate, while Dr. Richardson-Heron is leading patient engagement, specifically as it relates to diversity in clinical trials. With decades of experience in their respective fields, Dr. Absalon and Dr. Richardson-Heron are committed to their work—which includes advancing preventative measures for keeping Americans healthy—and educating the Black community on the importance of participating in clinical trials to inform scientific advancements through diversity.
MRNA vaccines use synthetic mRNA to introduce a component of the virus, which triggers the body’s cells to produce the viral protein that can be recognized by the immune system. If that occurs, the body is more prepared to fight the real virus.
In other words, “Vaccines trick your body into generating an immune response. Meaning, what you would do naturally is what vaccines do. They allow your body to go through the same process that happens naturally when confronted with an infectious organism,” explains Dr. Absalon.
She went on to further break down how the mRNA vaccine works to fight against COVID-19. “With this investigational vaccine, we’re taking a piece of the virus (or protein on top of the virus) that helps that bug get into the body and make people sick. We take a piece of that protein and wrap it up with a messenger RNA. It [then] goes into the body through injection and the body makes that protein.
“We are evaluating in clinical studies whether a person’s body then recognizes that there’s something that’s not supposed to be there and mounts a response. [Our bodies] make antibodies because we recognize something that’s not a normal part of the body. So, this vaccine is intended to train the body to elicit an immune response. The messenger RNA is a unique mechanism because [when] it enters the body, it uses the body’s cells to make that protein so that the body can react to it.” Pfizer was able to quickly focus on developing a COVID-19 vaccine candidate because of its established relationship for two years with BioNTech, which developed the mRNA platform.
Fighting COVID-19
As the fight against the virus persists and new information arises about the severity of the long-term effects on those infected, biopharma leaders and researchers are working expeditiously to develop a vaccine. And before a vaccine can be market-ready it must first be studied for safety and efficacy in clinical trials.
As outlined by Pfizer on its website, the study involves injecting participants with an investigational (study) vaccine and comparing outcomes against a placebo (injection with no active ingredient) to see if the vaccine can prevent COVID-19. Those eligible to participate in the current clinical trial are people 12 and older who are not pregnant, in good general health, and have not been previously diagnosed with COVID-19. Participants must also be willing and able to comply with all scheduled visits, the vaccination plan, laboratory tests, and other study procedures for two years.
Representation Matters in Vaccines, Too
As of Oct. 5, 2020, there have been 36,576 participants in Phase 2/3 in 120 clinical trial sites in four countries, including 39 states within the U.S. Additionally, Pfizer recently expanded the enrollment of its Phase 2/3 COVID-19 vaccine trial to approximately 44,000 participants, which allows for the enrollment of new populations including people living with chronic, stable HIV (human immunodeficiency virus), HCV (Hepatitis C virus), and HBV (Hepatitis B virus) infections.
The expansion of Phase 2/3 in the clinical trial presents an opportunity to evaluate the safety and efficacy of the vaccine candidate in a broader group of individuals.
“To that end, we have designed our COVID-19 vaccine candidate study in a way that is inclusive to meet the needs of potential study volunteers from diverse racial and ethnic backgrounds, including African Americans. We have selected investigator sites in diverse communities that have been disproportionately affected by COVID-19, and we are providing tools and information to help the clinical study site teams understand and align with our commitment to diverse representation in the study,” Dr. Richardson-Heron adds.
Moreover, Dr. Richardson-Heron expressed the importance of population diversity in clinical trials. “Studies have shown that race, environment, ethnicity, culture, age, and gender are all factors that may impact patient outcomes. But historically, many groups have not been fully represented in clinical trials for many different reasons. African Americans account for roughly 13% of the U.S. population but make up only 5% of clinical trial participants. Similarly, Latinx populations comprise roughly 18.5% of the U.S. population but make up only 1% of clinical trial participants. Underrepresentation makes it more difficult for researchers, regulators, and physicians to understand the extent to which a medicine or vaccine can help subsets of the population. As I always say, if you are not part of the research, you risk being left out of the cures or opportunities for prevention.”
“Let’s be clear, vaccine hesitancy is not a new issue. Only an estimated 45% of American adults received the flu shot in the 2018-2019 flu season. That number is even smaller when you look at adults who are people of color: just an estimated 39% of Black Americans and 37% of Hispanic Americans received the vaccine in the 2018-2019 flu season,” says Dr. Richardson-Heron. “So, there is a great deal of work that needs to be done now to rebuild trust, particularly for many communities of color. We fully recognize that it won’t happen overnight but it is certainly something we all have a responsibility to address. It’s on all of us to make the value proposition clear and to share how participating in clinical trials can help us all learn more and help eliminate health disparities.”
There is also the alarming truth that 1 in 1,000 Black people have died during the pandemic, according to research conducted by AMP Research Lab.
With this reality, Dr. Richardson-Heron says, “It should not be surprising that some people may be nervous and hesitant about participating in a clinical trial. Medical transgressions from the past understandably raise concerns in many communities and I clearly understand this. But it is very important to note that policies and procedures have been put in place to protect clinical trial participants from unethical activities. And as I said earlier, if we are left out of the research, we may be left out of the cures or preventions, potentially leading to an increase in the already unacceptable health disparities we see in the Black community and other communities of color.” She continues, “Given where we are, it is critically important to develop a COVID-19 vaccine candidate that is safe and effective for the populations it seeks to protect. That won’t be possible for a COVID-19 vaccine or any other medication or vaccine if Black people and other minority populations are not sufficiently included in the clinical trial. Coming out of this, we will take our learnings from the COVID-19 investigational vaccine trial and apply them to help us improve our efforts to achieve even greater diversity in all our clinical trials.”
When breaking down the value proposition, Dr. Richardson-Heron adds that it is key to seek credible and reliable health information.
Spreading the Word
To spread awareness about its robust vaccine development program and the clinical trial, Pfizer has formed strategic partnerships with organizations focused on the advancement of the Black community.
“In partnership with the Pfizer Multi-Cultural Center of Excellence, we are holding conversations with various medical, government, and community-based organizations to share more information about our trial, answer questions, and hear their perspectives. We are providing these organizations with resources based on that feedback to help raise awareness of the importance of participating in clinical trials,” says Dr. Richardson-Heron. She shares, “The NAACP sent a statement to its chapters indicating its support for clinical trial participation. We also partnered with the National Black Nurses Association to share information about the importance of participation in clinical trials via our ‘Ask the Expert’ FB Live series, and worked with Black Health Matters to share information via social media posts, banner ads, and the Black Health Matters newsletter.”
Expanding Vaccine Outreach
To have a greater impact, Pfizer is committed to expanding its outreach efforts.
“We are working with many of our sites on a 1:1 basis to better understand and enhance their efforts to develop impactful strategies to address local needs and mitigate any barriers unique to the underrepresented communities in their areas. Many of our investigator sites have established community networks and engagement strategies to engage diverse populations. To increase awareness about COVID-19 and what participants can expect when participating in the clinical trial, based on feedback from our site partners, we have developed patient-focused materials that have been translated into Spanish, Haitian Creole, Tagalog, Simplified Chinese, and Japanese. New languages can and will be added if identified as a need by our site partners,” says Dr. Richardson-Heron.
Dr. Absalon adds, “In the context of COVID-19, there’s been a renewal of commitment, and more effort, in terms of focus on what African American, Latinx, and other racial and ethnic minorities need to know so that they’re more willing to participate in clinical trials. One of the other things that we’re doing as a company is starting to build stronger relationships on the investigator side.” For Pfizer that means “working with the FDA Office of Minority Health and Health Equity; funding and sponsoring partnerships with historically Black medical schools; and establishing mentorship and fellowship programs. So, we are advocating across the board, not just with study participants, but with investigators as well.”
Giving Back Through Their Work
As Black women physicians in a science-based company, Dr. Richardson-Heron and Dr. Absalon do not take the impact of their work lightly.
“What I hope to achieve and what I’ve focused on to guide my career is making sure everyone has access: the Black community [and] people of lower socioeconomic status—every race, and every ethnicity. My goal is to make sure that everyone has access to preventative treatments, such as vaccines, as well as therapeutics.” Dr. Absalon adds, “Given how important this is for Black Americans, if they’re going to believe anybody, I hope they would believe a Black woman physician-scientist. We will do everything we can to bring forward research with scientific rigor. But it needs to be for everybody—and we in the Black community have to participate. We have to be well informed, and we have to participate.”
“I also want to reinforce that Pfizer is committed to developing and testing potential vaccines in accordance with high ethical standards and sound scientific principles. Safety is and will always be paramount in our clinical trials. As with all of our trials, we are following all of the rules and regulations in place to safeguard participant safety; for instance, the trial protocols are reviewed by regulatory authorities and approved by Institutional Review Boards or ethics committees, independent groups that review the methods proposed for each research study. In addition, the conduct of the trial is closely monitored by both Pfizer and an outside group of independent experts called a Data Monitoring Committee,” says Dr. Richardson-Heron.
Further, says Dr. Richardson-Heron, “At the end of the day, we want Black Americans and other communities of color to have the opportunity to benefit from biomedical research and the resulting medical advances so that we all can be healthy and live our best lives.”
To learn more about Pfizer clinical trials and how you can participate, visit Pfizer.com/science/find-a-trial.
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