While frontline healthcare workers faced devastating cases of COVID-19 head on, researchers and infectious disease experts got to work behind the scenes. Less than a year later, Connecticut is distributing two vaccines approved for emergency use by the FDA.
How mRNA vaccines work
Long before the Pfizer and Moderna vaccines hit the market, researchers spent years developing the technology that would make these vaccines possible. Both consist of genetic material called mRNA, which stimulate the immune system to protect against the virus.
During a Yale New Haven Hospital community town hall, Arjun Venkatesh, MD, Associate Professor and Chief of the Section of Administration in the Department of Emergency Medicine at Yale School of Medicine, compared getting the vaccine to giving the body a playbook.
“It’s got a picture of a protein on it. Your body sees that protein and says I don’t like this, it looks like the COVID virus, I’m going to make some antibodies,” Dr. Venkatesh said. “Those antibodies are stored in your body, and that playbook is stored in your body.”
Then if someone is exposed to COVID-19, antibodies know how to respond. Not only does the vaccine help protect against infection, it can also help to reduce the chances of hospitalization or death. After one dose, these vaccines are around 53% effective. After two doses, they are around 95% effective.
“I think we’re all pleasantly surprised and blow away as to how the vaccines we developed for COVID have turned out to be super highly effective compared to many other vaccines we’ve had for years and years,” said Onyema Ogbuagu, MB.BCh, FACP, FIDSA, Associate Professor of Medicine, Infectious Diseases at Yale School of Medicine, during another community town hall for Greenwich Hospital.
Diversity in clinical trials
Yale School of Medicine and Yale New Haven Hospital took part in Phase 3 of the Pfizer COVID-19 vaccine trial and Dr. Ogbuagu was the principal investigator. Clinical trials for these vaccines took part around the world and the Pfizer vaccine trial included around 40,000 participants. As the trial progressed in Connecticut, researchers placed a critical spotlight on diversity among their participants.
“For COVID-19, we do know at least in the United States that ethnic and racial minorities bare disproportional impact. So infection rates, hospitalization rates and deaths definitely occur more frequently, particularly in African Americans and Latinx individuals,” said Dr. Ogbuagu. “So it would make sense in a preventative vaccine, enrolling individuals that look like the people that suffer from the disease would be critically important.”
The groundwork to ensure diversity in this trial was already set thanks to the Cultural Ambassadors Program, a partnership between Yale Center for Clinical Investigation (YCCI) and local leaders. For over a decade, the program has worked to break down mistrust in the community due to a history of racism in healthcare and the disparities that still occur in the U.S. to this day.
“One thing that is really the currency for enrolling ethnic and racial minorities in clinical trials is trust. You know trust is important and this is not usually established in the short term, this is established over long-term relationships,” Dr. Ogbuagu said.
Distribution in Connecticut
Trust will remain a key component to the vaccine distribution in Connecticut, which relies on teamwork between the state, department of public health and organizations like Yale New Haven Health.
Richard Martinello, MD, Medical Director of Infection Prevention for Yale New Haven Health is a member of the governor’s vaccine advisory committee that reviewed data from the clinical trials. The group recommended the immediate distribution of the vaccine.
“There’s a fear that the review process for these vaccines was rushed, but that is not true,” said Dr. Martinello. “In addition to the review process from the FDA, the governor’s own advisory committee reviewed the data separately before concluding the vaccines are safe and effective.”
The FDA will continue to monitor the Pfizer and Moderna vaccines. So far, millions of people across the U.S. have gotten the vaccine safely.
“The vaccine will help us return to normal life but enough people need to get vaccinated first,” Dr. Martinello said.
In order to do just that, the state is allowing healthcare organizations like Yale New Haven Health to make tough decisions about distribution, like prioritizing frontline workers who have the highest risk of contracting the virus. It also means using up every available dose, so that none goes to waste.
Learn more about COVID-19 vaccines