In the year since the novel coronavirus ignited a pandemic, Rosalind Franklin University clinicians and researchers have provided frontline services to the community, including testing, diagnostics and, beginning in winter, administering the COVID-19 vaccine. Out of that spirit of service, trusted voices have emerged on the science behind the vaccine and the ongoing discovery that will ultimately vanquish the virus.
Vaccines developed at record speed by Pfizer-BioNTech, Moderna and Johnson & Johnson subsidiary Janssen Biotech are helping to turn the corner on COVID, which by March had claimed more than 500,000 lives in the United States and more than 2.5 million worldwide. The Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) — a mechanism to speed the availability of medical interventions for individuals — has been harnessed to develop countermeasures for the population at large during the public health emergency, a move that highlights the expertise of Archana Chatterjee, MD, PhD, dean of the Chicago Medical School.
“It’s an open question whether people will develop natural immunity that will protect against future infections.”
A specialist in pediatric infectious diseases, Dr. Chatterjee is a member of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), a panel of independent scientists and medical experts that reviews and debates safety and effectiveness data. She was thrust into the national spotlight after her Dec. 10 vote against the recommendation to authorize the Pfizer vaccine, which, as she explained in multiple national media interviews, was based on the limited data for clinical trial participants ages 16–17.
“I want to make it very clear that I am fully supportive of the Emergency Use Authorization of this vaccine for use in adults 18 and older,” Dr. Chatterjee told CNN news anchor Erin Burnett some two hours after the votes were cast. “We are facing a deadly pandemic, and the vaccine in addition to public health measures are needed. We need the science and the data.”
Dr. Chatterjee, who commended Pfizer for including children as young as 12 in its clinical trials and supported the collection of additional safety and efficacy data for review, received pushback on her vote.
“Yes, I received hate mail,” she said. “That happens. It was not unexpected. Anyone who does this work in the vaccine world gets criticized.”
A member of VRBPAC since 2018, Dr. Chatterjee has become a trusted messenger on the COVID-19 virus and vaccine, sitting for numerous television and radio interviews and weighing in via virtual discussions — local, regional, national and international.
“I have developed expertise in my field that can help benefit humanity,” she said. “As a physician, as a scientist, this is what you do. I am so grateful that RFU has been supportive of this work, understands the value of this work — both the FDA committee and our public education effort.
“Why am I getting so many requests? People view me as someone who is reliable and who has accurate information. The message has to be accurate. It has to be science-based, but it has to be in language people understand.”
Dr. Chatterjee was tapped in January and again in March by the Chicago public radio station WBEZ for its “COVID Conversations” virtual outreach to communities of color disproportionately affected by the virus. She joined Dr. Ngozi O. Ezike, director of the Illinois Department of Public Health, Dr. Allison Arwady, commissioner of the Chicago Department of Public Health, and community-based physicians in answering questions, including concerns about safety.
“Our strategy can be prophylactic but may be therapeutic as well. Inducing cellular immunity would kill infected cells, while post-infection inhibitors would prevent infected cells from producing viruses for transmission or new infection to achieve a complete cure.”
“The currently authorized vaccines do not contain the virus,” Dr. Chatterjee explained. “They are a blueprint for part of the virus — the spike protein. It cannot get into your DNA or become part of your genome. It gets into cells and helps make those proteins that our immune system recognizes, and makes antibodies to help fight the virus.”
Whether she’s discussing the platforms used to make vaccines or the threat posed by variants of the virus, Dr. Chatterjee frequently pauses and asks, “Does that make sense?” She works to counter what she calls the “chatter,” often on social media, that feeds vaccine hesitancy.
“There’s lots of misinformation and disinformation out there, and a lot of it is anecdotal,” Dr. Chatterjee said. “We’re hearing it from family, friends and neighbors. So how do we manage that? Each of us has a sphere of influence. Encourage people who are hesitant to talk to a doctor, talk to the people who actually know. Go to the websites where you find accurate information: the Centers for Disease Control and Prevention (CDC), the FDA, the World Health Organization (WHO).”
Dr. Chatterjee has published and presented extensively on the efficacy and safety of vaccines and has worked for decades to address vaccine hesitancy. She stressed the rigor of the EUA process — used previously just once, for an anthrax vaccine in 2005 — during a Feb. 9 Instagram Live conversation with David Everly, PhD, associate professor, Center for Cancer Cell Biology, Immunology and Infection.
VRBPAC routinely reviews applications for approval of new vaccines and also determines which viruses to include in the annual influenza vaccines for the northern and southern hemispheres — an undertaking that typically draws “zero interest” from the public or the media, Dr. Chatterjee noted. But faced with a deadly pandemic, the FDA very intentionally expedited its evaluation, bypassing the more time-consuming Biologics License Application (BLA) process typically used for approval of vaccines, while maintaining procedures for a rigorous, independent review. Vaccine manufacturers also accelerated their timeline, manufacturing millions of doses before receiving FDA authorization.
“They made a bet that the vaccines would work,” said Dr. Chatterjee, who is frequently asked if corners were cut in developing the new vaccine. The short answer is no. The science behind the current vaccines was already in use. The mRNA platform used by Pfizer and Moderna was developed a decade ago. The adenovirus vector technology, used by Johnson & Johnson, has been in the pipeline for years. So it was easy to quickly pivot to the development of COVID vaccines.
People also want to know how long the immunity stimulated by current COVID vaccines will last.
“We don’t know,” says Dr. Chatterjee in agreement with Dr. Everly, who cited emerging evidence of reinfection from new strains and variants.
“The virus counteracts the ability to make antibodies and our ability to fight it,” Dr. Everly said. “The important question is as new strains of the virus emerge in different parts of the world, whether existing immunity will work against those new strains. It’s an open question whether people will develop natural immunity that will protect against future infections.”
RFU researchers are quietly tackling the question of COVID immunity and investigation of potential therapeutics. Johnny He, PhD, director of the Center for Cancer Cell Biology, Immunology and Infection, is investigating a potential vaccine strategy based on the parasite Leishmania with Dr. Ying Liu, Dr. Kwang Poo Chang, Dr. Joseph Reynolds and a collaborator at Tulane University.
“The vaccines currently on the market are all based on the antibody response, but we don’t know if antibody immunity will last,” Dr. He said. “We’re exploring the possibility of using Dr. Chang’s platform, which is based on cellular immunity that primes specific T cells in the human body against COVID-19. The beauty of cellular immunity is its permanence.”
Dr. He and his lab partners are also pursuing a research platform to understand the basic science of the virus and to identify or screen post-infection inhibitors.
“The vaccine is a first step, it’s a start,” Dr. He said. “So many people infected with COVID have lingering symptoms or other issues. We need to allocate resources for basic research to develop new therapeutics. Our strategy can be prophylactic but may be therapeutic as well. Inducing cellular immunity would kill infected cells, while post-infection inhibitors would prevent infected cells from producing viruses for transmission or new infection to achieve a complete cure.”
As new COVID-19 vaccines move through the pipeline, including the 64 now in clinical development according to WHO, does Dr. Chatterjee foresee a final break in the chain of transmission?
“I always tell people I am not a virologist,” she said. “I am an infectious disease specialist. And in infectious diseases, we tell you what we know today; things may change by this afternoon. We will probably continue to boost people with new cocktails of viruses to fight new strains. Depending on what is circulating in the population, we may need a vaccine every year. ‘Stay tuned’ is my advice.”
Judy Masterson is a staff writer with the RFU Division of Marketing and Brand Management.