BCMS Alliance

Better Together

By Nichole Eckmann, 2021 BCMS Alliance President

Founded in 1917, the Bexar County Medical Society Alliance has been serving the medical community of San Antonio for over 100 years! BCMSA began as a group of physician spouses sewing surgical gowns, rolling bandages & knitting mufflers for WWI soldiers. We sure have grown as an organization since then! Our members now are physician spouses with various skills and passions, who are also dedicated to their families and supportive of the physician’s rigorous schedule and frequent absenteeism from the household. The organization has evolved from spouses being home taking care of the family 100% of the time to being business owners and professionals, putting equal amounts of work into their careers, a balancing act that is often challenging.

When I first joined this organization around 4 years ago, I wasn’t really sure what to expect. I was newly married to my husband Dr. Maxim Eckmann, and I had no idea what it was like to live the medical life. I was adapting to that and to our new blended family of 6 boys! I had moved to San Antonio about a year before we were married and I didn’t have many friends. I was looking for a supportive group with like-minded individuals who could give me pointers on juggling this life and who understood the complexities of being married to medicine. I was at a birthday party one day and the wife of one of my husband’s co-workers, Dr. Lori Boies, asked me if I knew about the Bexar County Medical Society Alliance. I said no I did not, but I was interested in hearing more about it. She did a great job of explaining what the Alliance was all about, and when I left that birthday party, I told my husband I was really going to think more about joining, because I felt it was important for me to meet new people. A few weeks later I joined the organization, and I was welcomed with open arms. I quickly made friends that I still have today, and I had an instant support system.

So why do I spend my time sitting on boards like the BCMSA with my often-crazy schedule of making breakfast for 6 kids every morning, taking time for exercise, managing a real estate business, keeping up with school functions and trying to make dinner every night? The answer is simple: camaraderie and a way to give back to the community. The medical life is one of a kind, one that you don’t understand unless you are living it. When I attend a board meeting or an event, I always connect with a member that “just gets it.” As President this year, that is, in a nutshell, what I’m hoping to achieve with my amazing Board in 2021. I want us to continue to make connections with other physician spouses and welcome them with open arms into this supportive group the way I was welcomed four years ago. Although times are challenging and have been a bit uncertain, we as an organization can be there for one another and continue to work together to give back to the community.

Danielle did a fantastic job in 2020 keeping the organization moving forward despite the fact we have not been able to have in-person events or meetings since March. We, as an organization, realized that the best way to deal with the uncertainty and worry was to continue to do what we do best — reach out to the community and give back. We continued to meet and create ideas for reaching out to our members and the community while setting an example of masking and social distancing. One example of this has been working with The Mitchell Chang Foundation to provide masks to low-income families and health care workers, specifically families in zip codes with the highest COVID-19 rates and economic need.

For decades we’ve provided scholarships for students pursuing healthcare careers. Our Scholarship Committee met virtually this past Spring, awarding 5 allied health scholarships and we established two new medical student scholarships. In March, BCMSA created a “we come to you” PPE Drive with volunteers spanning the county to pick up donations in their area of town. Nearly 2,000 items of personal protective equipment were collected and donated to the University of Texas Health Science Center at San Antonio whose physicians and other medical team members staff our county hospital.

The goal is to continue creating ideas in 2021 that will allow us to stay connected with each other as members and with our community as well. If anything, the truth is we ARE better together! Thanks so much to my presidential advisors and friends Dr. Lori Boies, Jenny Shepherd, Jennifer Lewis and past President Danielle Henkes for your continued support, and to my husband Dr. Maxim Eckmann for always bringing out the best in me and encouraging me to continue to fulfill my goals in life even if they sometimes seem out of reach. If anything, 2020 has shown us that if we stay connected, even if it is virtually, we can get through this! So, here is to 2021 and adapting to the unexpected!

Development of COVID-19 Vaccinations

By Alan Preston, MHA, ScD

Operation Warp Speed has resulted in the creation of two, soon to be three or more, COVID-19 vaccinations. This is excellent news for all who are anxious to get back to normal without the restrictions imposed on small businesses and individuals. Operation Warp Speed's goal is to have private industry develop a vaccine and quickly allow the supply chain to deliver 300 million doses of safe and effective vaccines. Many people are, however, skeptical as to the safety of the vaccinations. Even with a vaccine for H1N1, only 50% of the population decides to take a vaccine to prevent the disease.

The FDA has created the gold standard for the approval of prescription drugs. The objective of all clinical trials is two-fold; one to assure safety to the patients, and the second to ensure the intervention works as intended. The last goal is what we call efficacy.

Efficacy can be thought of in two ways for a vaccine: 1. Efficacy can attempt to prevent the disease and the transmission of such. 2. In the rare case someone gets COVID-19, does the vaccine protect against severe symptoms?

To test the hypothesis as to whether the trial is both safe and effective, four study phases are required for approval from the FDA: 1. The pre-clinical phase is the animal studies to determine safety and efficacy 2. Phase-1: Small human trials to assure safety and no adverse side effects (usually less than 100 subjects)

a. The proper dosage of the vaccine is tested at this phase to find the correct dosage 3. Phase-2: Moderate sample size of 100 to over 1,000 a. Trying to match the demographics of the target population who will receive the vaccine 3. Phase-3: Testing vaccine on humans a. Large sample size (30,000 to 60,000) b. The sample matches the demographics of the population c. Monitor how effective the vaccine is d. The population will have both the active and placebo vaccine

If all goes well, the trial goes to approval for the Emergency Use Authorization (EUA) from the FDA. Once the EUA is achieved, then the distribution of the vaccination is cleared. There is a lot of confusion at this step. Our country is based on a republic that separates the federal government's roles from that of the States and local municipalities. The federal government can set "guidelines" as to what the priorities should be as to who gets the vaccination first; however, it is up to each state and local officials to work with the private community to coordinate the vaccination of patients, frontline caregivers and the vulnerable.

The early distribution of the vaccinations has been smooth in some communities and a disaster in others. Blaming the federal government for the local municipalities' inadequacies will not make the process easier or more effective.

The two vaccinations that have EUA from the FDA are Pfizer and Moderna. Both companies use a similar approach to the development of the vaccination. Both locate the Messenger RNA from one of the many found on the COVID-19 virus proteins and use that protein, which contains the messenger RNA, to introduce it to the human host. The objective of vaccination is to have the host create antigens to attack the COVID-19 protein. Then the human host will develop antigens to fight off the foreign RNA, and by producing antigens to fight off the m-RNA, your body is one step ahead if you encounter the real COVID-19. How does this work?

Here is how it works. The scientist takes a lipid nanoparticle to introduce the m-RNA into a protective casing. To maintain the integrity of the lipid nanoparticle, the manufacture must keep it very cold; otherwise, the efficacy is lost in a few days of the vial of the vaccine. This creates a transport vehicle to introduce to the human hosts. The COVID-19 S-Protein is contained in the lipid nanoparticle. Once it gets into the host cell, the good news is that it does not enter into the cell's nucleus, where the cell's DNA is located.

The mRNA will begin making proteins using the cell's ribosomes. The ribosomes help decode the message. The process of making proteins from the mRNA is called translation. The new proteins get expressed on the cell membrane on two types of proteins. One of the existing cells' proteins is called MHC-2 protein, which is only found on antigen-presenting cells. The MHC-2 protein is only found on B-cells and Dendritic Cells, which act as messengers between the innate and the adaptive immune systems.

The body's response to attract is to attack the S-protein. But how does that work? The Thelper cell and the T-cell become activated, which begins to release a lot of cytokines. Interleukin 2 and 4, and 5 are created. It tells the B-cells to proliferate and to differentiate and have the plasma cells to make antibodies. The antibodies go after any virus that has an S-protein. It also stimulates the T-cells to produce memory antibodies.

How long will the antibodies stick around?

We don't know yet. It may be six months or nine months or longer, but time will tell. What we do know based on the clinical trials is that it is effective, over 95% for Moderna and 94.5% for Pfizer. Again, there are two ways to look at efficacy. One is against getting the disease, and the other is stopping the severity of the disease.

As an example, Moderna tested nearly 30,000 patients. They were divided into two groups; one group had the vaccine injected, the other had saline (the placebo) injected. For those who had symptoms and tested positive, this is what they found. For the placebo group, about 185 tested positive. For the vaccine group, only 11 tested positive; but in the vaccine group none had severe symptoms of COVID-19. In the placebo group, about 30 were severe cases. Therefore, Moderna’s efficacy against getting the disease is 185-11=174/185= 94%. Moderna vaccine’s efficacy for preventing severe symptoms of COVID-19 was 100%!

The challenge of keeping the vaccination cold is a real challenge to many communities throughout the USA. To store the vaccines and be viable, it needs to be -4 Fahrenheit for the Moderna, and it needs to be – 94 degrees Fahrenheit for Pfizer. And therein lies part of the problem with the distribution system. Which providers have the necessary freezers to keep the vaccine vials at such a low temperature?

Additionally, each vial can administer about ten patients. One of the issues is making sure that all ten doses are give to patients who show up at the same time to receive the vaccination. Another challenge is making sure that once patients receive the first injection, they return about 21 days later (Pfizer) or 28 days later (Moderna) for the second injection. The first injection is only about 57% efficacious and requires to have the second vaccination to become 95% effective. Managing this population to assure compliance with these parameters will be a challenge for the doctor's offices and other institutions that administer the vaccine.

What will it take to get to “herd immunity”?

There is not a definitive answer to that question; however, the consensus is about 75% of the population vaccinated can substantially mitigate the transmission of COVID-19. And of course, if the vaccine is administered to the vulnerable population in more significant percentages, the COVID-19 death rate should plummet. The other tremendous benefit of a vaccine is that it should mitigate the impact on hospitals and, in particular, the ICU beds. I suspect there is a significant population that needs attention to many other diseases that are not being addressed during this pandemic. If we continue to scare people from getting the necessary care they need, far more of those individuals will die from not being vaccinated than from those who actually get the COVID-19 disease.

Let's hope that these and other vaccines put an end to the COVID19 pandemic. We need to be patient and understanding as the local infrastructure evolves to manage the vaccines' dispensing. It is time to get the country opened up again and allow people to get back to work. The nature of people is to socialize; isolation is never good for a healthy society.

Alan Preston, MHA, Sc.D. works in the area of Population Health Management and has a doctorate in Science in Epidemiology and Biostatistics from Tulane University and has spent his entire career in the healthcare space.

Vaccine Acceptance –An Historical Perspective

By Kelly G. Elterman, MD

With the much-awaited arrival of the COVID-19 vaccine in December 2020, vaccination has become a frequent topic of conversation – discussed in hospitals, pharmacies, on social media, and around the dinner table. Everyone has questions, concerns, and opinions. Despite the ongoing pandemic and known risks of COVID-19 infection to both individuals and society, vaccine acceptance appears neither universal nor outright, even among healthcare workers.

In a recent JAMA study, scientists found that only 51%-61% of Americans would accept a COVID-19 vaccine if offered, depending on vaccine efficacy; 51% would accept a vaccine with 50% efficacy and 61% would accept one with 90% efficacy. The Lancet published a similar study, demonstrating a 67% acceptance rate. Internationally, vaccine acceptance varied depending on the country’s trust of its government, but was still less than the 70% needed to achieve herd immunity.

The reluctance or refusal to accept vaccination when it is available has been termed “vaccine hesitancy,” by the World Health Organization and has been identified in 90% of countries worldwide. In 2019, the WHO listed vaccine hesitancy as a top ten global health threat. While this phenomenon may seem a product of the modern age fueled by the spread of misinformation on the internet, it has actually afflicted society for centuries.

Vaccination has a long and complicated history. The first precursor to modern day vaccination appears to have occurred as early as 1000 AD in China, where smallpox sores were ground and inhaled. In the 1700s, small pox variolation – the practice of deliberate infection using dried smallpox scabs from an afflicted individual – was practiced in Asia, India, and the Ottoman Empire. The practice was promoted in England by Lady Mary Wortley Montagu, who variolated her son in Turkey, and in the colonies by Boston clergyman Cotton Mather, both of whom were heavily criticized despite evidence than only 2-4% of those variolated died, compared to 20-30% of those who became ill naturally.

Smallpox continued to kill many in Europe and the colonies throughout the 1700s. In 1796, Edward Jenner successfully demonstrated prevention of smallpox using vaccination with cowpox material. Four years later, Benjamin Waterhouse, a Harvard physician, introduced the practice to the United States when he performed the first vaccinations on his own children. Within a matter of years, the term “vaccination” emerged and the first U.S. Vaccine Agency established.

By the middle of the 19th century, vaccination of schoolchildren against smallpox became mandatory in the United Kingdom and in Massachusetts, the first US state to pass a vaccination law. Less than thirty years later, in 1882, a group known as the Anti-Vaccination League held its first meeting in New York at which speakers propagated the notion that smallpox was spread by filth, rather than contagion. Much like in modern-day, this idea spread successfully despite evidence to the contrary.

Another historical parallel to modern-day vaccine hesitancy is the 1905 case of Jacobson v. Massachusetts, in which the defendant argued that the Massachusetts law requiring smallpox vaccination violated his individual rights to decide what was best for his own body. The Supreme Court determined, however, that individual rights must fit within a framework of what is best for society as a whole, particularly during an epidemic. Interestingly, this case was settled in favor of public health over 100 years ago, yet the same argument persists a century later amidst a global pandemic.

Since smallpox, other diseases plaguing humankind have been successfully controlled if not eliminated through vaccination. In 1917, little more than a decade after Jacobson v. Massachusetts, the influenza pandemic began in the United States. Then, as now, public health measures such as masking were instituted with mixed acceptance, and scientists raced to develop a vaccine as the virus claimed the lives of more than half a million Americans. Unlike current times, however, it was 20 years before scientists could successfully isolate the virus and develop a vaccine, then another decade before the vaccine could be publicly available. Fortunately, vaccine development science has advanced such that we need not wait decades to find the tools to successfully prevent similar tragedies.

Various childhood diseases that previously resulted in death or disability are another example. Prior to vaccination, polio resulted in 15,000 cases of paralysis annually in the United States. Measles caused 3 to 4 million cases of illness, 48,000 hospitalizations and 500 deaths

each year. Through wide-spread vaccination, polio was eliminated from the United States in 1979 and measles in 2000. Ironically, it is this success that has allowed vaccine hesitancy to flourish. As time passes, disease prevalence declines and the public forgets the disease, the proven risks of illness become unrealistically compared to the perceived risks of vaccination. Measles illustrates this phenomenon well: after elimination in 2000, cases peaked in 2019, with the majority occurring in unvaccinated communities where many fear vaccine-related autism more than measles despite scientific evidence that the concern is unfounded.

While some vaccination fears are born from misinformation, others are based on actual, albeit minute, risk. Historically, smallpox variolation carried a risk of death. In 1955, a manufacturing error resulted in 11 deaths and hundreds of cases of paralysis among children vaccinated with the injected, killed poliovirus. More prominent in the public’s eye, however, are the cases of influenza that occur each year despite vaccination. With such events scattered throughout history, it is not difficult to understand why vaccine hesitancy exists.

In sharp contrast to those who refuse vaccines are the scientists and volunteers who accept risk for the sake of societal benefit. These too, are found throughout history. Centuries ago, it was those subjecting themselves and their children to variolation. More recently, it was Dr. Mikhail Chumakov and his wife, Dr. Marina Voroshilova, a pair of Russian scientists who tested Dr. Albert Sabin’s live-attenuated polio vaccine on themselves and their children to prove its safety and efficacy when neither the United States nor the Soviet Union would conduct trials of a live vaccine on children. Their confidence and bravery ultimately led to the development of trials and the approval of the oral polio vaccine, which subsequently benefited countless children worldwide. Today, it is the COVID-19 vaccine trial volunteers and the frontline workers willing to take the vaccine immediately despite the concerns of their families, friends, and colleagues.

Vaccination, its acceptance and refusal have an interesting history that appears, as all unstudied history, to repeat itself. Over time, the diseases change but the arguments remain the same. Despite many forms over the centuries, it is still the spread of misinformation, little of which is fact-based, that is responsible for fear and mistrust leading to vaccine hesitancy and the resultant public health consequences. Nonetheless, the facts and numbers remain: throughout history and in modern day, vaccination results in the decline of disease and illnessrelated death.

We are fortunate to live in a time where our scientific advances allow us to forget the scars of childhood diseases and to develop tools to fight new viral foes within a matter of months. If only we could fight vaccine hesitancy as quickly.

Kelly G. Elterman, MD is a board-certified anesthesiologist and independent contractor in San Antonio and is a member of the Bexar County Medical Society. References: 1. Kreps S, Prasad S, Brownstein JS, et al. (2020). Factors Associated

With US Adults’ Likelihood of Accepting COVID-19 Vaccination. JAMA Network Open, 3(10), e2025594. https://doi.org/10.1001/jamanetworkopen.2020.25594 2. Malik AA, McFadden SM, Elharake J, Omer SB. (2020). Determinants of COVID-19 vaccine acceptance in the US. EClinicalMedicine, 26, 100495. https://doi: 10.1016/j.eclinm.2020.100495. 3. Lazarus, J.V., Ratzan, S.C., Palayew, A. et al. (2020). A global survey of potential acceptance of a COVID-19 vaccine. Nat Med, 1-4. https://doi.org/10.1038/s41591-020-1124-9 4. MacDonald, N. E. (2015). Vaccine hesitancy: definition, scope and determinants. Vaccine 33(34), 4161-4164. https://doi.org/10.1016/j.vaccine.2015.04.036. 5. World Health Organization. (2019). Ten threats to global health in 2019. The World Health Organization. https://www.who.int/news-room/spotlight/ten-threats-toglobal-health-in-2019 6. The Lancet Child & Adolescent Health. (2019). Vaccine hesitancy: A generation at risk. The Lancet Child & Adolescent

Health, 3(5):281. https://doi.org/10.1016/S23524642(19)30092-6. 7. The College of Physicians of Philadelphia. (2020). The History of Vaccines – An Educational Resource. https://www.historyofvaccines.org/multilanguage/timeline 8. Edwards KM & Hackell JM. (2016). Countering Vaccine Hesitancy. PEDIATRICS, 138(3):e20162146. https://doi.org/10.1542/peds.2016-2146. 9. Centers for Disease Control and Prevention. (2020). Measles.

Centers for Disease Control and Prevention. https://cdc.gov/measles 10. Centers for Disease Control and Prevention. (2020). Global immunization. Centers for Disease Control and Prevention. https://cdc.gov/polio 11. Kramer, A. (2020 June 24). Decades-Old Soviet Studies Hint at

Coronavirus Strategy. The New York Times. https://www.nytimes.com/2020/06/24/world/europe/vaccine-repurposingpolio-coronavirus.html

Mistrust of the COVID-19 Vaccine in African American Communities: A Problem that Stems Far Back from this Pandemic

By Antonio Webb, MD

With thousands of front-line workers and other members of our society already receiving the first round of COVID-19 vaccinations around the world, there is a subset of our population that still have doubts and hesitancy surrounding it: African Americans.

The Issue at Hand

This hesitancy and lack of trust is multifactorial, stemming way back to the 1800s. During this time, James Marion Sims, a national and renowned doctor who later became known as the “Father of Gynecology,” performed medical experiments on enslaved women. These women, who by his definition of their position in society, could not provide informed consent. During this time he performed experimental operations, many times without anesthesia. This was in part because he didn't believe black women experienced pain in the same way that white women did. Between 1930 and 1970, 65% of the 7,600 plus sterilizations ordered by the state of North Carolina were carried out on black women.1 For nearly half of the 20th century, black women were forcibly sterilized often without their knowledge. Some of these women were sterilized during cesarean sections and were never told; others were threatened with termination of welfare benefits or denial of medical care if they didn’t “consent” to the procedure; others received unnecessary hysterectomies at teaching hospitals as practice for medical residents. In the south, it was such a widespread practice that it had a euphemism: a “Mississippi appendectomy.”

The US Public Health Service began the Tuskegee study in 1932. Black males in Macon County, Alabama, who had already contracted syphilis, were recruited to participate in the study.2 These men were told that the purpose of the trial was to study and understand whether syphilis progressed differently in black people as compared to white people. Although a novel treatment at the time, penicillin became widely available a few years later in 1943, but these black males were intentionally not treated. Unfortunately, many of these black males died from untreated syphilis by the time the study was halted in 1972. Many others went on to infect their wives, some of whom then transmitted the disease to their children.

Fast forward to 2021, there are a lot of similarities between Dr. James Sims’ experimental operations in the mid 1800s, the unconsented sterilizations of black women and Tuskegee experiments in the 1930s, and disparities in COVID-19 - all which highlight the systematic and structural discriminations that have and currently exist in the United States. It is well known that black and minority patients are more likely to die of preventable diseases such as heart disease and stroke. They also have higher rates of cancer, asthma, influenza, pneumonia, diabetes, and HIV/AIDs. For many of them, structural racism and unequal treatment remain a contributing factor to disease and death. There is an abundance of literature also showing that racial and ethnic minority groups are being disproportionately affected by COVID-19.3-5 It is said that black Americans are infected with COVID-19 at nearly three times the rate of white Americans and are twice as likely to die from the virus. This is due to many of the inequities in social determinants of health. These include discrimination, lower rates of health insurance coverage, barriers to accessing healthcare, educational inequalities, income and wealth gaps, and limited access to quality housing to name a few. These factors and others are associated with more COVID-19 cases, hospitalizations, and deaths in areas where racial and ethnic minority groups live, learn, play, and worship.6 Beyond these factors, research shows that historic and widespread abuse and mistreatment of communities of color by the medical system and ongoing racism and discrimination drive disparities in healthcare. This contributes to lower quality of care, distrust of the healthcare system along with stress and trauma.7

Dr. Susan Moore, an African American physician, is just one example. She died in Dec 2020 following multiple hospitalizations for complications from COVID-19. Acutely aware of her deteriorating condition, she repeatedly asked for medications to treat her pain; imaging studies to assess her dyspnea and routine checks while admitted to the hospital, all while under the care of a white physician. She noted on widely shared social media posts that her pain was dismissed during her stay and that she didn't trust the hospital system. She expressed being treated like a drug addict and was reportedly told to be discharged home from the hospital despite her reported symptoms. She publicly cried for help by stating, "I put forth and maintain, if I was white, I wouldn’t have to go through that. This is how black people

get killed, when you send them home and they don’t know how to fight for themselves.” Despite being a physician herself and saving countless lives during her medical career, her outcry for adequate and fair treatment could not save her own. This highlights the fact that even being an educated physician in our country does not exclude one from the systemic and structural racism.

A recent pew research report highlighted the fact that black Americans are less inclined to receive the COVID-19 vaccination than other racial and ethnic groups: 42% would do so compared to 63% of hispanics and 61% of white adults. Another recent report from UnidosUS, the NAACP, and COVID collaborative revealed that just 14% of Black Americans and 34% of Latino Americans say they have trust in the safety of a new COVID-19 vaccine. The study also found that 18% of Black and 40% of Latino respondents trust the COVID19’s vaccine effectiveness.8 The unfortunate reality is that Black people in this country have been trained, over many centuries, to distrust both the government and medical community on the issue of healthcare and hence the hesitation and lack of trust of the COVID-19 vaccine.

Our Roles as Clinicians

As clinicians, our job is to first assimilate knowledge about various conditions, treatments, medications and then impart this information to our patients in a shared decision-making manner. To date (as of this writing), 300,000+ people have lost their lives to this deadly virus.9 Black Americans have been disproportionately affected by pandemic morbidity and mortality, and this experience is reflected in hesitancy attitudes and behavior towards the COVID-19 vaccine. As leaders in our communities, we must first build trust. Having healthcare providers from diverse backgrounds that are of the same race and gender is critical. Studies show that black patients have better outcomes when treated by black doctors. For example, a Stanford University study looked at black men in Oakland, California and paired them with either Black or non-Black doctors. The men seen by Black physicians were more likely to engage with them, and even consent to preventive services like cardiovascular screenings and immunizations. They found that the effects were most pronounced for men who have little experience obtaining medical care and among those who mistrust the medical system.10 To those points, we must work directly with our community leaders and amplify the voices of people of color to ease fears, build trust and disseminate factual evidencebased information about the vaccines. Only then will we be able to start healing and recovering from the mistrust, physical, and psychological damage imparted on the black race and culture for hundreds of centuries in the past.

Dr. Antonio Webb is an Orthopedic Spine Surgeon located in San Antonio, Texas with the South Texas Spinal Clinic. To contact Dr. Webb, please email toniowebb@gmail.com or more information about Dr. Webb can be found at www.antoniowebbmd.com or www.youtube.com/antoniowebbmd. Dr. Webb is a member of the Bexar County Medical Society.

REFERENCES 1. Stern AM. Sterilized in the name of public health: race, immigration, and reproductive control in modern California. Am J Public

Health. 2005;95(7):1128-1138. doi:10.2105/AJPH.2004.041608 2. https://www.cdc.gov/tuskegee/timeline.htm 3. Stokes EK, Zambrano LD, Anderson KN, et al. Coronavirus Disease 2019 Case Surveillance — United States, January 22–May 30, 2020. MMWR Morb Mortal Wkly Rep 2020;69:759–765. 4. Killerby ME, Link-Gelles R, Haight SC, et al. Characteristics Associated with Hospitalization Among Patients with COVID-19 —

Metropolitan Atlanta, Georgia, March–April 2020. MMWR Morb

Mortal Wkly Rep. ePub: 17 June 2020. 5. Gold JA, Wong KK, Szablewski CM, et al. Characteristics and

Clinical Outcomes of Adult Patients Hospitalized with COVID19 — Georgia, March 2020. MMWR Morb Mortal Wkly Rep 2020;69:545–550. 6. https://www.cdc.gov/coronavirus/2019ncov/community/health-equity/race-ethnicity. html#fn2 7. Institute of Medicine. 2003. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington, DC: The National Academies Press. https://doi.org/10.17226/12875. 8. https://static1.squarespace.com/static/5f85f5a15 6091e113f96e4d3/t/5fb72481b1eb2e6cf84 5457f/1605837977495/VaccineHesitancy_BlackLatinx_Final_11.19.pdf 9. https://coronavirus.jhu.edu/ 10.https://siepr.stanford.edu/research/publications/does-diversity-matter-health-experimentalevidence-oakland

Vaccine Implementation

By Bryan Alsip, MD

On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization for the PfizerBioNTech COVID-19 vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). From a public health standpoint, this represented a significant turning point in our war against COVID19, marking a deliberate shift in strategy from defense to offense. Having been on the defensive for over a year, that was a refreshing change. The authorization of the Pfizer-BioNTech vaccine also brought its own challenges. Although praised for early data which suggest the vaccine is safe and effective, it has strict storage and handling requirements. Specifically, vials of vaccine must be kept frozen between -112ºF and -76ºF, which requires an ultra-low temperature freezer not readily available to most immunization providers. As federal and state governments made decisions regarding allocation, only those organizations that had enrolled as vaccine providers and had indicated they could meet the ultra-low temperature storage requirements were designated to receive the Pfizer-BioNTech vaccine. Therefore, week 1 allocations of the COVID-19 vaccine in Texas went almost exclusively to hospitals.

Those hospitals and health systems began immunizing their staff as recommended by both the CDC’s Advisory Committee on Immunization Practices (ACIP) and the Texas Expert Vaccine Allocation Panel (EVAP), but the supply of vaccine did not initially meet the demand. Some hospitals did not receive enough doses, or even any vaccine. Furthermore, Health Care Workers, as defined by the Texas EVAP for Phase 1A, includes an extensive range of staff and providers working both inside and outside of the hospital setting.

As we have seen throughout this pandemic, our community found ways to collaborate. Several organizations that received initial allocations began to share vaccine and to immunize others. University Health partnered with the Southwest Texas Regional Advisory Council (STRAC), the City of San Antonio, Bexar County, and other healthcare providers, to offer vaccinations to EMS providers who en-

gage in 9-1-1 emergency services like pre-hospital care and transport, staff in outpatient care settings who interact with symptomatic patients, and healthcare workers in corrections and detention facilities.

On December 18, 2020, the FDA issued an emergency use authorization for the Moderna COVID-19 vaccine, which demonstrated similar safety and efficacy as the Pfizer-BioNTech version with some logistical advantages. Although it is shipped frozen (between -13ºF and 5ºF), the Moderna vaccine does not have the same ultra-low temperature storage requirements. The Moderna vaccine also does not require dilution and, after being thawed, can stay refrigerated for up to 30 days prior to use. This makes the vaccine easier to store and administer, which enables more organizations to play a role in offering the vaccine. Week 2 allocations of the COVID-19 vaccine in Texas included the Moderna product and were shipped to a larger group of immunization providers including physician offices, urgent care clinics, and pharmacies. Unfortunately, many of these allocations were very small, with several locations receiving only the minimum supply of 100 doses.

During the same week, the Texas Department of State Health Services (DSHS) published their recommendations for Phase 1B COVID19 vaccine allocation. As with several other states, these guidelines differed from those published by the CDC’s Advisory Committee on Immunization Practices (ACIP), by not recommending the vaccine next for frontline essential workers, but rather focusing “on people for whom there is strong and consistent evidence that COVID-19 makes them more likely to become very sick or die.” Although this extensively broadened the population for which the COVID-19 vaccine was indicated, it also further exacerbated the COVID-19 vaccine supply and demand inequity.

COVID-19 vaccines offer great promise in our battle against the adverse health effects of this pervasive disease, but we still have several immediate needs: we need more vaccine supply; we need more organizations to enroll as vaccine providers to administer the vaccine; and we need more clear communication regarding where those who are recommended to receive the vaccine can do so. I have the privilege of working with many dedicated leaders and professionals in our community who are committed to addressing these issues.

As of this writing, University Health has begun to offer the COVID-19 vaccine to individuals in the Phase 1B category through a large vaccination setting and other organizations are also finalizing plans to provide immunizations to this vulnerable population. The state of Texas is communicating that if vaccine providers administer the vaccine they will get more, and so is strongly encouraging that no doses be held in reserve. With the timing of the second dose of approaching for those who were immunized early, and a larger eligible population, we need a consistent and growing supply of vaccine to be provided.

Just recently, the COVID-19 vaccine developed by the University of Oxford and AstraZeneca was authorized by regulators in the U.K. and in India, bringing yet another weapon to the global fight against this novel coronavirus. It is the most logistically forgiving of the three major vaccines to date since it only requires refrigeration for storage, which opens up supply to a vast network of existing immunization infrastructure. However, researchers are estimating that FDA authorization of the Oxford AstraZeneca vaccine may not come until April 2021. Until then, we must maximize the availability and administration of both the Pfizer-BioNTech and Moderna vaccines in the coming months.

As more organizations in Bexar County enroll to become immunizers, more vaccine is provided by the state and federal governments, and more venues become available to our community residents, we can protect more people against symptomatic COVID-19 disease. At a time when hospitalizations for COVID-19 patients in Texas are at an all-time high, this is more important than ever. If you or your organization traditionally offers immunizations, please become a part of this endeavor. Enroll as a COVID-19 vaccine provider with the Texas Department of State Health Services (DSHS) at https://enrolltexasiz.dshs.texas.gov/emrlogin.asp and immunize your staff and eligible patients as guidelines recommend. We need more community contributors to expand our vaccination efforts and help make 2021 the year we turn the tide on this historic pandemic.

Bryan Alsip, MD MPH FACPM is Executive Vice President and Chief Medical Officer for the University Health System and is a member of the Bexar County Medical Society.

The Importance of COVID-19 Vaccination for Healthcare Personnel Updated Dec. 15, 2020 (CDC)

Based on recommendations from the Advisory Committee on Immunization Practices (ACIP), an independent panel of medical and public health experts, CDC recommends healthcare personnel be among those offered the first doses of COVID19 vaccines.

Healthcare personnel include all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials. This recommendation pertains to paid and unpaid healthcare personnel working in a variety of healthcare settings—for example, acute care facilities, long-term acute care facilities, inpatient rehabilitation facilities, nursing homes and assisted living facilities, home health care, mobile clinics, and outpatient facilities, such as dialysis centers and physicians’ offices.

Examples of healthcare personnel include: Emergency medical service personnel, nurses and nursing assistants, physicians, technicians, therapists, dentists, dental hygienists, and assistants.

Who is included under the broad term “healthcare personnel”? Phlebotomists, pharmacists, students, and trainees, contractual staff, dietary and food services staff, environmental services staff, and administrative staff. Healthcare personnel are at risk of exposure because they are on the front line of the nation’s fight against this deadly pandemic. Healthcare personnel’s race and ethnicity, underlying health conditions, occupation type, and job setting can contribute to their risk of acquiring COVID-19 and experiencing severe outcomes, including death.

By providing critical care to those who are or might be infected with the virus that causes COVID-19, healthcare personnel have a high risk of being exposed to and getting sick with COVID19. As of December 3, the day CDC published these recommendations, there were more than 249,000 confirmed COVID-19 cases and 866 deaths among healthcare personnel. View more recent numbers on the toll COVID-19 has taken on healthcare personnel by visiting the CDC website.

Vaccinating healthcare personnel protects healthcare capacity.

The Phases of COVID-19 Vaccine Administration By Centers for Disease Control (CDC)

The first vaccines for prevention of coronavirus disease 2019 (COVID-19) in the United States were authorized for emergency use by the Food and Drug Administration (FDA) (1) and recommended by the Advisory Committee on Immunization Practices (ACIP) in December 2020.* However, demand for COVID-19 vaccines is expected to exceed supply during the first months of the national COVID-19 vaccination program. ACIP advises CDC on population groups and circumstances for vaccine use.†

PHASES

On December 1, ACIP recommended that 1) health care personnel§ and 2) residents of long-term care facilities be offered COVID-19 vaccination first, in Phase 1a of the vaccination program (2).

On December 20, 2020, ACIP recommended that in Phase 1b, vaccine should be offered to persons aged ≥75* years and frontline essential workers (non–health care workers), and,

In Phase 1c, persons aged 65–74 years, persons aged 16–64 years with high-risk medical conditions, and essential workers not recommended for vaccination in Phase 1b should be offered vaccine.**

These recommendations for phased allocation provide guidance for federal, state, and local jurisdictions while vaccine supply is limited. In its deliberations, ACIP considered scientific evidence regarding COVID-19 epidemiology, ethical principles, and vaccination program implementation considerations. ACIP’s recommendations for COVID-19 vaccine allocation are interim and might be updated based on changes in conditions of FDA Emergency Use Authorization, FDA authorization for new COVID-19 vaccines, changes in vaccine supply, or changes in COVID-19 epidemiology.

Following ACIP’s interim recommendation for vaccine allocation in Phase 1a (2), the Work Group proposed vaccine allocation for Phases 1b and 1c. A description of the population groups in these phases, supporting scientific data, consideration of ethical principles, and considerations for vaccination program implementation are presented in this report, and supporting evidence is available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19/evidencetable-phase-1b-1c.html.

Phase 1b

Approximately 49 million persons, including frontline essential workers (non–health care workers) and persons aged ≥75* years are recommended to receive vaccine in Phase 1b of the COVID-19 vaccination program (Table). Essential workers perform duties across critical infrastructure sectors and maintain the services and functions that U.S. residents depend on daily. The Cybersecurity and Infrastructure Security Agency (CISA) of the U.S. Department of Homeland Security has developed a list intended to guide jurisdictions in identifying essential critical infrastructure workers, who may be exempted during stay-at-home-orders (3). ACIP used CISA guidance to define frontline essential workers as the subset of essential workers likely at highest risk for work-related exposure to SARS-CoV-2, the virus that causes COVID-19, because their work-related duties must be performed on-site and involve being in close proximity (<6 feet) to the public or to coworkers.

ACIP has classified the following non–health care essential workers as frontline workers: first responders (e.g., firefighters and police officers), corrections officers, food and agricultural workers, U.S. Postal Service workers, manufacturing workers,

grocery store workers, public transit workers, and those who work in the education sector (teachers and support staff members) as well as child care workers.§§ A tiered approach for essential workers builds on the occupations identified by the National Academies of Science, Engineering and Medicine for early vaccination (4).

Persons aged ≥75 years are at high risk for COVID-19–associated morbidity and mortality. As of December 20, 2020, the cumulative incidence of COVID-19 among persons in this age group was 3,839 per 100,000 persons, with a cumulative hospitalization rate of 1,211 per 100,000, and a mortality rate of 719 per 100,000 (7–9). The overall proportion of persons aged ≥75 years who live in a multigenerational household is 6%; the proportion among non-Hispanic White persons is 4%, and the proportion among racial or ethnic minority groups is higher (non-Hispanic Black persons, 10%; Hispanic or Latino persons, 18%; non-Hispanic persons of other races, 20%).***

Phase 1c

In Phase 1c, vaccine should be offered to persons aged 65–74 years, persons aged 16–64 years††† with medical conditions that increase the risk for severe COVID-19, and essential workers not previously included in Phase 1a or 1b.

Based on ongoing review of the literature, CDC has identified medical conditions or risk behaviors that are associated with increased risk for severe COVID-19.§§§ The risk for COVID-19–associated hospitalization increases with the number of high-risk medical conditions, from 2.5 times the risk for hospitalization for persons with one condition to 5 times the risk for those with three or more conditions (10). According to a recent analysis of 2018 Behavioral Risk Factor Surveillance System data, at least 56% of persons aged 18–64 years report at least one high-risk medical condition (CDC COVID-19 Response Team, Division of Population Health, personal communication, December 2020). Essential worker sectors recommended for vaccination in Phase 1c include those in transportation and logistics, water and wastewater, food service, shelter and housing (e.g., construction), finance (e.g., bank tellers), information technology and communications, energy, legal, media, public safety (e.g., engineers), and public health workers.****

Implementing vaccination programs to reach essential workers will pose challenges. Use of multiple strategies is recommended to reduce barriers to vaccination,†††† such as providing vaccination opportunities at or close to the workplace. State and local health authorities will need to take local COVID-19 epidemiology and demand for vaccine into account when deciding to proceed to the next phase or to subprioritize within an allocation phase if necessary. A flexible approach to allocation will facilitate efficient management and ensure that COVID-19 vaccine is administered equitably and without delay. Additional interim considerations for phased implementation of COVID-19 vaccines are available at https://www.cdc.gov/vaccines/ covid-19/initialpopulations.html and https://www.cdc.gov/vaccines/covid-19/phased-implementation.html.

Phase 2 Phase 2 includes all other persons aged ≥16 years not already recommended for vaccination in Phases 1a, 1b, or 1c. Currently, in accordance with recommended age and conditions of use (1), any authorized COVID19 vaccine may be used.

References *65 years or greater in Texas 1. Food and Drug Administration. COVID-19 vaccines. Silver Spring, MD: US

Department of Health and Human Services, Food and Drug Administration; 2020. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccinesexternal icon 2. Dooling K, McClung N, Chamberland M, et al. The Advisory Committee on

Immunization Practices’ interim recommendation for allocating initial supplies of COVID-19 vaccine—United States, 2020. MMWR Morb Mortal Wkly

Rep 2020;69:1857–9. CrossRefexternal icon PubMedexternal icon 3. Cybersecurity and Infrastructure Security Agency. Guidance on essential critical infrastructure workers: version 4.0. Washington, DC: US Department of

Homeland Security, Cybersecurity and Infrastructure Security Agency; 2020. https://www.cisa.gov/publication/guidance-essential-critical-infrastructure-workforceexternal icon 4. National Academies of Sciences, Engineering, and Medicine. Framework for equitable allocation of COVID-19 vaccine. Washington, DC: National Academies of Sciences, Engineering, and Medicine; 2020. https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-th e-novel-coronavirus#sectionPublicationsexternal icon 5. Bui DP, McCaffrey K, Friedrichs M, et al. Racial and ethnic disparities among

COVID-19 cases in workplace outbreaks by industry sector—Utah, March 6–

June 5, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1133–8. CrossRefexternal icon PubMedexternal icon 6. Waltenburg MA, Victoroff T, Rose CE, et al.; COVID-19 Response Team.

Update: COVID-19 among workers in meat and poultry processing facilities—

United States, April–May 2020. MMWR Morb Mortal Wkly Rep 2020;69:887–92. CrossRefexternal icon PubMedexternal icon 7. CDC. Coronavirus disease 2019 (COVID-19): CDC COVID data tracker.

Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://covid.cdc.gov/covid-data-tracker 8. CDC. COVID-NET: laboratory-confirmed COVID-19–associated hospitalizations. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html 9. CDC. Weekly updates by select demographic and geographic characteristics: provisional death counts for coronavirus disease 2019 (COVID-19). Atlanta,

GA: US Department of Health and Human Services, CDC; 2020. https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#Age-

AndSex 10. Ko J, Danielson M, Town M, et al. Risk factors for coronavirus disease 2019 (COVID-19)–associated hospitalization: COVID-19–Associated Hospitalization Surveillance Network and Behavioral Risk Factor Surveillance System.

Clin Infect Dis 2020. E-pub September 18, 2020. CrossRefexternal icon Pub-

Medexternal icon 11. McClung N, Chamberland M, Kinlaw K, et al. The Advisory Committee on

Immunization Practices’ ethical principles for allocating initial supplies of

COVID-19 vaccine—United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1782–6. CrossRefexternal icon PubMedexternal icon 12.CDC. COVIDView: a weekly surveillance summary of U.S. COVID-19 activity.

Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html

The COVID-19 Vaccine in Texas The Texas Tribune –December 23, 2021 (Excerpts*)

Doses of the COVID-19 vaccine began arriving in Texas in mid-December, marking a significant milestone in the battle against the virus. But it will be months before vaccine doses are widely available, and the rollout is leaving eligible Texans with more questions than answers.

For now, the limited supply is prioritized for front-line health care workers and certain high-risk populations.

Who is eligible for the COVID-19 vaccine in Texas?

Front-line health care workers and long-term care facility residents pening on the ground. Providers have 24 hours to report their vacci-

and staff are the prioritized groups to receive doses of the vaccine as part of Phase 1A of distribution.

Phase 1B prioritizes Texans who are 65 years and older, and people who are at least 16 and have qualifying health conditions that put hem at an increased risk for severe illness from COVID-19. According to the Texas Department of State Health Services, some of these conditions are: • Cancer. do myself.”

• Chronic kidney disease. • Chronic obstructive pulmonary disease. • Heart conditions, such as heart failure, coronary artery disease or cardiomyopathy. • Solid organ transplantation. • Obesity and severe obesity. • Pregnancy. • Sickle cell disease. • Type 2 diabetes mellitus.

Why is my provider saying they don’t have a vaccine available?

As thousands of Texans have come to discover in recent weeks, doses of the coronavirus vaccine have remained in short supply.

Shipments of the vaccine first began arriving at Texas hospitals on Dec. 14. Under Phase 1A of the state’s rollout, the limited supply was reserved for front-line health care workers, as well as residents and staff members of nursing homes and other long-term care facilities, which have been decimated by the virus.

On Dec. 21, Dr. John Hellerstedt, commissioner of DSHS, announced that Texans 65 and older, and people who are at least 16 with certain medical conditions, would be next in line. This group is reHow is Texas keeping track of who’s gotten the first dose?

The Texas Department of State Health Services has a map that tracks where doses of the coronavirus vaccines are going and how many people are receiving them. The state’s dashboard also separates the numbers by the phase — either 1A or 1B.

But the state’s numbers could lag up to two days behind what's hapnation statistics to the agency, which updates its numbers each afternoon with data reported by midnight the day before.

Who decides who is eligible to receive doses of the vaccine?

Decisions on how doses of the vaccine are allocated are made by a state panel of advisers — including lawmakers, state and local health officials, and medical experts and researchers. The group, known as the Expert Vaccine Advisory Panel, provides recommendations for final approval by Hellerstedt.

Is the COVID-19 vaccine safe?

Yes. Although some Texans have expressed hesitancy toward the vaccine, health experts and public officials widely agree that the vaccine is safe. The two currently approved developers — Pfizer and Moderna — reported their vaccines are 95% and 94% effective, respectively.

While no vaccine is without side effects, clinical trials for both Pfizer and Moderna show serious reactions are rare.

Abbott received his first dose of the vaccine last month, telling reporters, “I will never ask a Texan to do something I’m not willing to ferred to as 1B.

Do I need to get the vaccine if I already had the virus?

The short answer is yes. Health experts still don't know how long natural immunity lasts after someone gets COVID-19, but there has been evidence suggesting it does not last very long. The vaccine can offer you protection against the coronavirus even after you've had it.

When will Texas get more COVID-19 vaccine doses?

New doses of the vaccine will continue to arrive in Texas over the coming months. Public health experts estimate it will take between six and nine months for the vaccine to be widely available to everyone who wants it.”

BCMS COVID-19 Vaccination Event

January 10, 2021 at the Bexar County Medical Society Building