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Western NY Responds to COVID
Western NY Responds to COVID: Vax Trials, Informing and Vaccinating the Public
Randi Minetor
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COVID-19, the biggest public health crisis of our lifetime, requires the most comprehensive response ever mobilized in every region around the world—and health systems throughout the Buffalo, Niagara Falls, and Rochester metropolitan areas have risen to the challenge.
The pace has not slackened since early March 2020, when the first cases appeared in Monroe and Erie counties. Hospitals have worked tirelessly to care for the sick, employing new therapies as soon as they become available. Clinical trials have allowed local residents to participate in vaccine development. Medical personnel are learning valuable lessons about a set of lingering symptoms that persist long after the virus has passed—what news networks call the “long haulers”—and what these mean to each patient’s ability to recover. Every day brings new information and a greater understanding of the disease, from university research labs to primary care physicians’ offices.
Vaccines: development and distribution
As the first vaccines arrived in early 2021, the focus remains on prevention: conducting clinical trials of additional vaccines against the virus and its variants. Scientists at the University of Rochester Medical Center continue to work with AstraZeneca/University of Oxford on clinical trials for its vaccine.
The University has a long history of participating in the development of effective vaccines, including its leadership in trials of the HPV vaccine, which works to prevent several types of cancer caused by the human papilloma virus. Ann Falsey, MD, a professor at the University of Rochester School of Medicine, and Angela Branche, MD, assistant professor in the UR Department of Medicine, Infectious Diseases, lead the phase 3 coronavirus vaccine study, which recruited 1,000 in Rochester between the ages of 18 and 85. Preliminary results reported by AstraZeneca in November 2020 found the vaccine to be up to 90 percent effective with “no serious safety events.”
Meanwhile, virus mutations have emerged in the United Kingdom, South Africa and Brazil—an expected development, said Dr. Falsey in a recent report to UR alumni on January 28. “RNA viruses mutate rapidly—it’s just what they do,” she said. “This is not a new phenomenon.”
On February 25, the University of Rochester Medical Center and Rochester Regional Health announced that they would participate in a new clinical trial to study the effectiveness of a booster dose of the Pfizer vaccine in protecting people from COVID-19 variants for the long term.
The new South African variant may become the dominant strain, Dr. Falsey said, because of its ability to bind to the spike protein, where it attaches to the ACE receptor. “Perhaps this strain binds more tightly; that might be why it seems to be taking over as the dominant strain,” she said. Concerns that this mutation may be more deadly than the original virus, however, have not been borne out by data yet. “This is very multi-factorial,” she cautioned. For example, “if a healthcare system is overwhelmed, you can have increased mortality because of scant resources.” She quoted the United Kingdom’s chief science advisor, Patrick Vallance: “If you took…a man in their 60s, the average risk is that for 1,000 people who got infected, roughly 10 would be expected to unfortunately die with the virus. With the new variant, for 1,000 people infected, roughly 13 or 14 people might be expected to die.”
Current vaccines from Pfizer and Moderna appear to neutralize this new strain as well as the original, she said, but
scientists need more data before saying with certainty that they are as effective. “There may be reduced efficacy rather than no efficacy,” she said, meaning that individuals who are vaccinated might still contract COVID, but they could have a much milder case.
Reaching the patient
Getting vaccines into the arms of western New York’s 2.3 million residents represents its own monumental challenge, even as larger volumes of the vaccine begin to arrive through the federal government’s purchase and distribution effort. Thanks to efforts to inform the medical community and the general public about various vaccines’ safety, demand has been high, said Dr. Branche. “When we were learning, 72 percent of people said they would definitely or probably get a vaccine,” she said in the January 28 presentation. “Since then, people were wary of the rapid rate of development; changes in the political administration might have affected development. This created hesitancy. So the rate dropped to 51 percent. In November 2020, the acceptance rate increased after the election to 60 percent.”
This would not be enough to achieve the herd immunity rates that will allow normal life to resume throughout the area, Branche said. “Gender, race, political party are all factors
in acceptance,” she said. “One of the biggest problems we’re I was going to be the first taking this, and my wife, who works working through is that there are differences in whether here, would be the second. I have children working here, and people will accept the vaccine based on race and ethnicity, and they were going to be vaccinated, too. They asked about inferwe’re dealing with a pandemic that disproportionately affects tility, Bell’s palsy, all the things they’d heard about. I told them people of color.” 24 million people had already been vaccinated and there were
Branche and her team began the process with surveying no deaths, so do the math.” URMC employees in all departments to determine where Dr. Vazquez managed to change many minds with clear they would find resistance to the vaccine. Just 60 percent said information. When vaccines began to arrive, however, he they were willing to be vaccinated, a level of acceptance that only received 150 doses as part of phase 1a. He vaccinated as would still leave many employees at risk. To respond to this, many staff members as he could. “Then we had a town hall UR leadership scheduled a series of town halls for employees a week later,” he said. “Now 95 percent were happy they got over three or four days, with presentations focused on the the vaccine, and said they would be ambassadors for it in the areas in which each group worked. “We had 21,733 people community. That changed everything.” eligible for phase 1a vaccines, and to date, 81 percent have He managed to procure another 500 shots on the verge of received the vaccine,” she said. “Only 15 percent declined it expiration from a local hospital, and quickly vaccinated the after the town halls. This is pretty extraordinary.” rest of the staff. Second shots were easier to come by, complet-
Taking this approach to reducing hesitancy out into the ing the cycle with front-line staff; getting vaccines for patients community is a much larger and more complex process, she has been more difficult. said. “That’s requiring a lot of community engagement, working with the advisory committee of leaders in the community,” including the collaborative organization Common Ground Health and its CEO, Wade Norwood. “We’ve been able to be fully engaged in all of this—[for example] I participated “The governor created a pop-up site at the Belle Center,” a in a Zoom talk with community center in downtown Buffalo not far from his the Barbershop and practice, Dr. Vazquez said. “We gave 360 vaccines, reaching a Cosmetology Asso- lot of black and brown populations. If you have someone who ciation of Rochester. looks like you going through the process, it makes a differIt will take a lot more ence. I can say, ‘Listen, this is just amino acids and a little fat Raul Vazquez, MD, FAAFP effort to get us to the droplet. And I got it myself.’” 80 percent vaccinations we’re looking for.”
A similar approach generated an equally positive effect in Buffalo, where Raul Vazquez, MD, FAAFP, president and CEO of G-Health Enterprises, sent a survey to his staff members and found that between 60 and 70 percent of them said that they would not get the vaccine. G-Health’s Urban Medical Practice serves as the health home for 9,000 people living in Buffalo’s inner city communities, so with so many staff members resistant to the vaccine, he knew they could put their patients at serious risk. “We had a virtual town hall for staff,” Dr. Vazquez said. “I had a pharmacist who described the vaccine itself. I told them
The power of primary care
For Richard Charles, MD, chief medical officer at the Buffalo primary care practice General Physician, frustration with the process stems from the vaccine distribution being entirely out of primary care doctors’ hands. “We could have managed this quickly,” he said. “We vaccinate people for everything else.”
Instead, the vaccines are going from the state to the University at Buffalo for community clinics, and to pharmacies. “They had no built-in process for this,” he said. “They had to build it all from baseline. So we are working to help our
Richard Charles, MD
patients navigate this system. It’s a very disjointed process. I’ve had people be on the phone for hours and not get their appointment, and others get one in ten minutes. My father walked in and got a vaccine, and my mother can’t get scheduled. We are mostly gatekeepers.”
To make things more complicated, the novel approach used by the RNA vaccines developed by Pfizer and Moderna makes many of General Physician’s patients wary, he said. “How much stronger a recommendation can I give than that I ran to the hospital and got it as soon as I could?” Dr. Charles said. “I had one patient in his nineties who said, ‘I’ll wait to put some miles on the tires before I get it.’ I explained that this technology dates back to Ebola and SARS; it’s just the storage situation [requiring that the Pfizer vaccine be stored at temperatures below -70° C, and the Moderna vaccine between -25° C and -15° C] that it’s not being used. Then he got online and got his appointment.”
Dr. Charles serves on a 34-member COVID task force with state and local officials, working to create guidelines before the vaccine goes into wide distribution to the general population. “What’s critical is that as the vaccine becomes more plentiful, how do we make sure that the patients get it? The weather will be improving, people will be able to move around again, but the critical nature of getting these people vaccinated will not change. One way we can make our community a better place is to make sure people get what they need and get vaccinated. That’s going to have an impact on our society being able to function.”
Comorbidities and lingering symptoms
As of February 15, New York State had moved into phase 1c of its vaccination rollout, making people with a long list of health issues and comorbidities eligible to be vaccinated: pregnancy, heart conditions, hypertension, diabetes, cancer, kidney or liver disease, pulmonary disease, a weakened immune system, severe obesity, and neurological disorders.
Comorbidities like these can increase the risk of getting COVID, and they can also lead to a range of symptoms that linger long after the initial virus has passed. These have given rise to what many call “long haul” illness, a condition that can strike COVID survivors of any age.
These symptoms can be very different from one patient to the next, involving an ongoing cough, crippling fatigue, overall achiness and joint pain, shortness of breath, insomnia, headaches, loss of the senses of taste and smell, recurring fever, and the “brain fog” that many patients have difficulty describing: confusion, forgetfulness, and inability to concentrate. Some experience persistent nausea and diarrhea, while others report erectile dysfunction. For some, the symptoms appear even after several weeks of feeling fairly well after recovering from the virus.
Very little research exists on this sequelae phenomenon, elevating the importance of one pre-publications study in Seattle, as detailed in a research letter in JAMA Network Open. While this information is not peer-reviewed yet, it offers some early insights: Almost a third of people with COVID experienced lingering symptoms six months after they contracted the virus, with fatigue and loss of smell or taste the
most persistent complications. The study has piqued interest in part because it examines all patients with COVID in this medical center, while previous studies have only followed those who were hospitalized. “Many of these individuals are young and have no pre-existing medical conditions, indicating that even relatively healthy individuals may face long-term impacts from their illness,” wrote co-author Denise McCullock, MD, MPH, at the University of Washington.
This adds validity to local physicians’ observations of what has become known as “post-COVID syndrome,” underscoring that it can affect people who had no comorbidities before they contracted COVID.
Dr. Vazquez shared one theory that may account for this syndrome in people with comorbidities. “When your hypertension is out of control, for example, it creates ACE receptors in the lungs. ACE receptors let the virus in. Once COVID gets in the lung, it creates an inflammatory process throughout the body, and starts to form micro-clots. Wherever you have the clots, that’s where the damage occurs.” A patient with tiny blood clots in the heart may have a heart attack; one whose clots occur in the reproductive system may become infertile, and so on.
Patients with cardiovascular disease may be more at risk for a complicated course with COVID infection, said Vijay Iyer, MD, PhD, chief of cardiovascular medicine at the Jacobs School of Medicine & Biomedical Sciences at the University at Buffalo. “Even for those who have no heart disease, cardiovascular involvement is possible.”
Dr. Iyer has seen patients with COVID who have developed myocarditis, an inflammation of the heart muscle—even in young athletes, making them unable to play their sport. Others develop pericarditis, a condition in which fluid accumulates in the wall around the heart. “There is also increased propensity to form clots in the blood vessels leading to clots in the lungs and even strokes,” he said.
While most people do not develop these issues, they can happen in otherwise healthy people who contract COVID, Dr. Iyer said. “Actual incidence is pretty low, perhaps less than five percent overall,” he said. “But no one medication changes the course of COVID and cardiovascular disease. Nothing is a panacea to any of these problems other than social distancing, masking and eventually vaccination.”
A December meeting sponsored by the National Institutes of Health in Baltimore and covered by the New York Times brought together researchers, public health officials, and patients for a first-ever workshop focused on this syndrome. “This is a phenomenon that is really quite real and quite extensive,” said Anthony Fauci, MD, the country’s top infectious disease expert. This acknowledgement from the top came as a
Vijay Iyer, MD, PhD
relief to patients experiencing the syndrome, many of whom had been dismissed by emergency room doctors and primary care physicians who defined their symptoms as anxiety or PTSD. A number of these patients formed Body Politic, an online COVID-19 support group at www.wearebodypolitic. com/covid-19, where patients share information about their symptoms, medical treatment, and early research.
University medical centers in western New York are not currently involved in researching post-COVID syndrome. In New York City, however, the Icahn School of Medicine at Mount Sinai has created the Center for Post-COVID Care, with the opportunity for patients experiencing the longterm effects of the virus to participate in a registry and share information with the medical staff. This program may become a model for other medical centers to emulate as they tackle this disease’s ability to compromise health long after the virus itself has passed.
With research taking place on so many aspects of this virus, however, more understanding may come soon. “We have advanced very quickly in this space,” said Stephen Dewhurst, moderator of the UR presentation on January 28. “It’s astounding how far we’ve come in a very short time.”
Randi Minetor is the author of Medical Tests in Context: Information and Insights (Greenwood, 2019) and is a freelance journalist in upstate New York.
