Romano Law Nurse Corner #27
More Vaccine Studies and Long Term Health Effects
Vaccine Trials and Antibodies
Last Tuesday, AstraZeneca had to suspend one of its leading COVID-19 vaccine trials due to an unexplained illness in one of its participants. The vaccine was developed with the University of Oxford and is considered one of the most promising and the most advanced in terms of development. This was discouraging news but not something scientists were surprised about.
Scientists say pauses in clinical trials are common and the time out is needed to be sure that it is safe to continue. By Saturday, the university said it had been deemed safe to continue the trial. They said that it was “expected that some participants will become unwell in such large trials.”
As an added measure of safety for participants of this and similar trials, the pause or stop of a trial and whatever potential safety issue arises is evaluated by an independent safety review committee. This is an important safeguard so that whatever the issue might be, it is not evaluated by a party interested in pushing the outcome in a direction for their own purposes. The rush to find a vaccine can never be more important than safety in human subjects. This pause shows that even with the highest stakes, the scientists are not ignoring important safety concerns to get a vaccine more quickly. As of today, the AstraZeneca trial has been resumed.
As the COVID-19 spread continues at an alarming rate here in the US, there is constantly more virus data available for doctors and scientists trying to make sense of this disease. We learn more about how COVID-19 affects the body and how the body reacts in response to an infection with the virus. Production of antibodies by the body is essential data in terms of developing a vaccine.
Early research suggested that antibodies that the body makes in response to COVID-19 infection could fade quickly in people and that those who were asymptomatic might not make any antibodies at all.
Recently, a more encouraging study was published in the New England Journal of Medicine suggesting that antibodies against the coronavirus could remain stable for at least 4 months after a diagnosis. This study involved more than 30,000 people in Iceland and found that antibody levels rose for 2 months after infection and plateaued through the 4 month mark.
Some other interesting trends were noted in this study including that antibody levels were higher in older and hospitalized patients, women had lower antibody levels than men, and smokers had lower antibody levels than non-smokers.
Given the large group of patients, it is also interesting that one third of people reported no symptoms. Another interesting note is that not everyone infected developed antibodies, which might be indicative of a weaker immune response to the virus. It could also be a result of a false positive test, never having had the virus at all. Not surprisingly, they found that measuring actual antibodies in the blood is more effective than using testing like nose swabs to find the virus.
This encouraging study is important because it provides hope that host immunity to this unpredictable and highly contagious virus may not be fleeting and may be similar to that elicited by most other viral infections, experts from Harvard University and the U.S. National Institutes of Health who did not participate in the study wrote in a commentary published alongside the research. This would mean that a safe and well-developed vaccine could be very effective.
Something important that we do not know from this study is how the antibodies reflect immunity against and inhibition of the virus. Just because antibodies exist does not mean that they will protect from future infections. Cases of re-infections, while in the news, are very rare.
More Information about Long Term Health Effects from COVID-19
Stories are now emerging about longer-term repercussions and health issues in those recovering from COVID-19 infections. Interviews on the news and social media show the physical devastation these people have had to withstand. Many people have a hard time shaking symptoms. Others just cannot get their energy back. Whether it is a “brain fog”, heart and lung damage, mental and neurological issues, general weakness, this virus takes its toll on the health of those who have it in many varied ways.
Many of the patients have lingering or even permanent symptoms. In fact, as many as 1 out of 3 patients who are recovering from COVID-19 could experience neurological or psychological after-effects of their infections. These symptoms range from headaches, dizziness, and lingering loss of smell or taste, no energy, brain fog, depression, etc. Doctors are concerned that patients may suffer long lasting damage to their heart, kidneys, and liver from the inflammation and blood clotting the disease causes.
Dr. Wes Ely, a pulmonologist and critical care physician at Vanderbilt University Medical Center says that the problem for these people is not over when they leave the hospital.
As doctors and scientists strive to learn more about this virus on a daily basis, no one really knows when or even if patients with lasting neurological and other symptoms will get better.
Teodor Postolache, professor of psychiatry at the University of Maryland School of Medicine, says that approximately 30 to 50% of people with an infection with clinical manifestations are going to have some form of mental health issue…either anxiety or depression but also nonspecific symptoms that include fatigue, sleep, and waking abnormalities, a general sense of not being at your best, not being fully recovered in terms of the abilities of performing academically, occupationally, potentially physically.
Doctors and researchers cannot say how to treat and prevent neuropsychological manifestations of COVID-19 nor why the brain is affected.
Lena Al-Harthi, chair of the Department of Microbial Pathogens and Immunity at Rush Medical College, opines that if you have an uncontrolled level of inflammation that leads to toxicity and dysregulation… I am concerned about long term effects. She talks about the long-term effects in both the patients who were hospitalized but also the ones who were never hospitalized, generally the younger group of patients.
With mounting evidence that COVID-19 survivor’s face months or years of debilitating complications, healthcare experts are beginning to study possible long term costs.
Bruce Lee of the City University of New York (CUNY) Public School of Health estimated that if 20% of the U.S. population contracts the virus, the one-year post-hospitalization costs would be at least $50 billion, before factoring in longer-term care for lingering health problems. Without a vaccine, if 80% of the population became infected, that cost would balloon to $204 billion.
Similar to the health effects of HIV or the health impacts of the 9/11 Twin Tower Attack first responders, it will be years before the costs for those who have recovered as well as society as a whole, can be fully calculated. This comes from the wide toll COVID-19 takes on multiple organs and body systems including heart, lung and kidney damage that will require costly care.
One Journal of the American Medical Association Cardiology study of COVID-19 patients in Germany aged 45-53, found 75% of them suffered from heart inflammation, which could lead to future heart failure. Another Kidney International study found that over one third of COVID-19 patients in a NY medical system developed acute kidney injury with nearly 15% requiring dialysis.
Dr. Marco Rizzi in Bergamo, Italy, one of the early epicenters of the pandemic, says his hospital has seen 600 COVID-19 patients for follow up and has found that 30% have lung issues, 10% have neurological problems, 10% have heart issues and 9% have lingering motor skill problems.
In Milan, Dr. Moreno Tresoldi of San Raffaele Hospital has seen over 1,000 COVID-19 patients in follow-up. Few had major cardiology problems, however 30-40% have neurological problems and at least 50% have respiratory conditions. It seems clear that there will be some multitude of wide ranging post COVID-19 diagnoses and immeasurable impacts to our health system.
Data is evolving at all levels. COVID-19 has changed every aspect of our world. Last week’s remembrance of 9/11 Attacks reminded us of a time where Americans pulled together as a nation and cared for each other in ways we never imagined. We need to be there again. We continue to be in this together. We will continue to promote safety to decrease spread, wear masks to protect those around us in public, always frequent handwashing and social distancing.
MY MASK PROTECTS YOU: YOUR MASK PROTECTS ME
Susan Ramsey is both an attorney and an RN. Ms. Ramsey’s professional experience began as a Registered Nurse in the Intensive Care Unit at Yale New Haven Hospital. While pursuing her Bachelor’s Degree, she was a counselor with the New Haven Rape Crisis Program. During her time with the Program, Ms. Ramsey counseled sexual assault survivors and performed seminars for local police departments, universities, and high schools. During her time working as a registered nurse, Ms. Ramsey decided to attend law school. Ms. Ramsey graduated from CUNY Law School, and has practiced law in several different State and Federal Courts. She is a Florida Heath Care Risk Manager and a member of the Palm Beach County Sober Home Task Force. Ms. Ramsey actively litigates cases involving catastrophic injuries and wrongful death on behalf of survivors, cases include injuries suffered by victims of professional negligence, product liability and medical negligence.
Amie Goldberg is both an attorney and a certified APRN. After completing a Bachelor of Arts Degree at Whittier College, Ms. Goldberg attended nursing school at Emory University. Ms. Goldberg’s professional experience started as a Registered Nurse at Egleston Children’s Hospital taking care of children with congenital heart disease. After a few years, she continued working in all areas of the hospital while attending Kennesaw State University on weekends in order to get her Master’s Degree in Nursing with a specialty of Primary Care Nurse Practitioner/Family Nurse Practitioner. During her time as an APRN, Ms. Goldberg decided to attend law school at St. Thomas University in Miami, Florida. Since graduating, she has mainly practiced in the areas of personal injury and worker’s compensation, fighting for the rights of injured people. Since joining the Romano Law Group, Ms. Goldberg has been the Director of the Opioid Litigation Project. Ms. Goldberg also practices in the area of medical malpractice and nursing home negligence, bringing an inside perspective and knowledge to help get justice for our clients.