The fast development of COVID-19 vaccines from Moderna, Pfizer and Johnson & Johnson has been remarkable — but it raised questions from all sides of the country about the vaccines’ safety and efficacy.
For you and other members of our Black communities, the skepticism may not just be about the quick-moving process, but a deeper distrust rooted in a difficult history.
As a health care provider, we do not ignore or deny the medical mistreatment that has happened in America. But we hope to earn the trust of all our patients and community members through our faith-based mission, scientific research and whole-person approach.
We all want to stop losing our neighbors to the virus, get back to visiting our loved ones in person, sending kids safely back to school and regaining our lives.
Here’s what we need to do to make that happen.
Vaccine Transparency and Regaining Trust
The next step in finding relief from the pandemic is to vaccinate 80 to 85% of the population, achieving what’s known as herd immunity. Of course, before taking that step and having a shot injected into your body, it makes sense for you to wonder what’s in that vaccine and how it’s made.
There are currently some vaccine production methods for COVID-19 that have been using mRNA to trigger the body’s immune system to produce protective antibodies without using the actual virus.
How mRNA Works in the Vaccines
While vaccines for some other illnesses — such as the varicella (chickenpox) vaccine — actually use bits of the virus in the vaccine to create what’s called a “live virus vaccine,” the COVID-19 vaccines being produced do not contain any virus material, live or inactivated.
Instead, some coronavirus vaccines essentially work by using synthetic mRNA to direct the body to produce a small amount of the spike protein. Once the vaccinated person’s immune system detects this protein, their body begins producing protective antibodies to defend against coronavirus.
Experts say that the protective antibodies will recognize and prevent COVID-19 from getting into the body’s cells in the future, should that person be exposed to coronavirus.
“I’m the chair of our scientific review committee for COVID-19,” says Alric V. Simmonds Jr., MD, AdventHealth General Surgeon, Chief Health Equity Officer and Chief Medical Officer. “We’ve had a lot of time to really look at the scientific data — the effectiveness and the risks versus benefits of this vaccination,” he explains, adding, “Quite honestly, I did have some initial hesitancy [about the COVID-19 vaccine], but I’m a scientist, and I believe in the science.”
Achieving Emergency Use Authorization
This is the first time a synthetic mRNA vaccine is being widely distributed. The technology allows mRNA vaccines to be developed faster than traditional methods of vaccine development.
But the path of development and distribution is not faster because any safety checks have been skipped — it’s faster because of the technology used to create it and the emergency use authorization (EUA) process followed for distribution.
Diversity in Vaccine Development and Trials
Once a vaccine application is approved, the vaccine can begin testing in clinical trials on adult volunteers. Clinical trials are conducted in three phases, and by Phase 3, the trial enlists thousands of people to learn more about how the vaccine works and how their immunity to the disease compares to those who have not received the vaccine.
Moderna, the biopharmaceutical company behind one of the available COVID-19 vaccines, shared that their 30,000-person Phase 3 study included more than 11,000 people from communities of color, including over 3,000 Black participants.
Pfizer, also a biopharmaceutical company behind an available COVID-19 vaccine, has stated that approximately 42% of their overall trial participants, and 30% of U.S. participants, have diverse backgrounds, with 10% being Black Americans.
The trial stage is important for providing the information the FDA needs to approve the vaccine.
At any stage, if the vaccine doesn’t seem to be safe or effective, the FDA may stop the study.
Safe Enough for EUA
The vaccines currently available are EUA approved but they do not yet carry FDA approval. During a public health emergency, the FDA can use EUA authority to allow the use of unapproved products to treat or prevent serious, life-threatening diseases, such as coronavirus.
According to the FDA, before they can issue an EUA for a vaccine, the Secretary of Health and Human Services must make a declaration of emergency or threat to justify authorization of emergency use.
The FDA also explains that an EUA is a different standard than an FDA approval; however, in the case of an investigational vaccine developed for the prevention of COVID-19, both require submitting data demonstrating the vaccine’s safety and effectiveness.
So that means that none of the COVID-19 vaccines currently available have bypassed safety screenings — they’ve just gone through the authorization process quicker because coronavirus is a worldwide medical emergency.
“Vaccinations have helped populations of people survive serious illnesses,” Dr. Simmonds explains. “If you’ve gone to school or if you’ve played team sports, you’ve been vaccinated for measles, mumps, chickenpox and other illnesses. Our bodies tolerate vaccines very well and they keep us safe.”
History of Medical Mistreatment in America
Understanding the science behind the COVID-19 vaccines may help ease some hesitancy around getting vaccinated, but for our Black communities, we know it’s about much more. Dr. Simmonds agrees, explaining that “People of color in this country have received intentional medical wrongdoing from government officials, and the community remembers that.”
There’s a long history of racist mistreatment that has led to distrust when it comes to medical care, such as the Tuskegee experiments from 1932 to 1972 where Black patients were unknowingly used for syphilis research purposes and then never given treatment to cure their illness. “These atrocities are historic, but not forgotten,” says Dr. Simmonds. “This is especially true during a pandemic when you think about a treatment being something that someone has to put into their own body. That distrust and hesitance are very real.”
“We understand, and we want to help people get to where they need to be to prevent this disease,” he explains.
As a Black American, the facts and statistics support believing that you — your neighbors, your family members, your ancestors — have been treated unfairly based on race or ethnicity when seeking medical care.
When we look at women who are more likely to die from pregnancy-related causes, for example, there’s a clear discrepancy. The deaths per 100,000 live births for Black, American Indian and Alaska Native women older than 30 was four to five times as high as it was for white women, according to the Centers for Disease Control and Prevention (CDC).
“The term ‘justified skepticism’ sums it up perfectly,” Dr. Simmonds says. “We understand why many people are skeptical of medical treatment.”
And although he understands why some are still unsure about the vaccine, Dr. Simmonds urges the community to look at the science behind it.
“Please don’t let your fear prevent you from getting a vaccine that can save you,” he says. “If you do, you may end up like many of the patients who are in my ICU now — people whose families cannot be with them when they’re taking their last breath.”
According to the CDC, Black and Hispanic individuals are 2.8 times more likely to die from COVID-19. Over 375,000 Americans, including many people of color, have already died as a result of the disease. “So make the right choice — roll up your sleeve and get the shot,” Dr. Simmonds urges.
Choose to Get Vaccinated When Possible
We’re here for you every step of the way as new COVID-19 developments arise. Visit the Coronavirus Resource Hub for more news and updates from your trusted team of medical experts. We are distributing vaccines as quickly as possible based on CDC and state government guidelines. For more information about when the vaccine will be available for you, we encourage you to sign up for email alerts at www.CoronavirusVaccineAlerts.com.