Freedom from restrictions means COVID is free to run rampant

Dr. Hart talks about why vaccine refusal perpetuates the emergence of new COVID variants (like delta) and prevents our progress toward ending the current pandemic.
“Millions of researchers, clinicians, public health officials, volunteer EMTs and vaccinators have devoted innumerable hours to developing and deploying a solution to the COVID-19 pandemic at an astoundingly rapid pace — not only in vaccine discovery and production, but also in complicated systems and processes established and nimbly adapted as necessary to deliver on a vaccination timetable. This work is rooted in evidence-based information. That means clinical and public health decisions rely on the best data we have at any given time to deliver the best care for individuals, communities and the population at large. That principle fosters the most edified management possible.”

The vaccines we have are good. But they could be so much better

Written by Michael V. Callahan, former Covid-19 special advisor to the assistant secretary for public health preparedness at the Department of Health and Human Services, and was incident commander for nine international highly dangerous pathogen outbreaks. He is the director of Clinical Translation at the Vaccine and Immunotherapy Center at Massachusetts General Hospital.

And by Mark C. Poznansky infectious diseases physician and director of the Vaccine and Immunotherapy Center at Massachusetts General Hospital and an associate professor at Harvard Medical School.

The Search Continues: Coronavirus Vaccination Not “One-Size Fits All”

A number of the leading COVID-19 vaccines, including the first to market, rely on new platforms. These are technologies that have been developed over years, even decades, to target not just a single disease, but to take advantage of a key scientific development to affect a range of (current and future) clinical needs. Messenger RNA, which underpins the first two vaccine candidates is one such example – developed for other purposes and now deployed to combat a previously unknown virus.

At the Massachusetts General Hospital (MGH) Vaccine and Immunotherapy Center (VIC), we have been developing a self-assembling vaccine (SAV) platform that activates the immune system to attack specific targets. The core of the platform is a protein adapted from the bacterium that causes tuberculosis (called the protein core) and that powerfully displays fragments of proteins to the immune system. In our Self-Assembling Vaccine platform, any protein sequence from a new virus can be readily attached to the protein core to quickly make a vaccine. In 2014, for example, using Lassa virus, we went from viral sequence through pre-clinical testing in only 120 days. (Suffice it to say, that is fast!)

Knowledge of the immune response to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 or COVID-19) infection has been accumulating at an almost unimaginable pace. Dr. Patrick Reeves and his team at VIC, in collaboration with Voltron Therapeutics Inc., have developed a method for sifting through the knowledge and identifying the regions of the novel SARS-CoV-2 virus that the immune system targets most strongly. Each individual’s immune response is different, as indicated by the varying degree of illness that people experience once exposed to COVID-19. For this reason, rather than selecting a few precise sequences of the virus, Dr. Reeves and his colleagues chose an array of viral regions that appear again and again in different experiments. While a given individual may or may not respond well to a specific sequence within the region, most people’s immune systems will identify something within the pattern or grouping to which it will react in order to protect the person from the foreign invader – in this case, the coronavirus.

Will we need to vaccinate the whole world every year?

This next line of vaccines, like the SAV platform being developed by VIC, will prove to be very important. While the early reports and press releases from Pfizer, Moderna, and Astra-Zeneca are impressive and exciting, many unanswered questions remain. The first centers around durability of the immune response. More specifically, will we need to vaccinate the whole world every year? Unlike the front-running candidates, which are focused on stimulating antibodies in response to vaccine exposure, the SAV platform is aimed at training the T-cells (sometimes called memory cells) that are thought to provide longer lived immunity. T-cells are part of the adaptive immune system or active immune response; they recognize foreign substances, including infections, that they were exposed to in the past and then produce antibodies to attack the foreign body – kind-of like a precursor to or director of antibody production.

Regardless, second generation vaccines, like the one being developed at VIC, are critical for the overarching response

Next, there is the question of access and distribution of vaccines that require ultra-low temperature storage and multiple doses. Plus, safety concerns may emerge as follow up continues with ongoing trials. While rare and hopefully not serious, untoward side effects or adverse reactions could limit the number of people who should otherwise receive the vaccine. Progress thus far has happened at record speed; therefore, we dare to hope that the frontrunners will be enough to suppress or eliminate COVID-19 worldwide. Regardless, second generation vaccines, like the one being developed at VIC, are critical for the overarching response. In addition, the SAV platform can be applied to emerging infectious and other diseases where the immune system needs to be targeted, including coronaviruses in general, viral and bacterial infections, the next pandemic, and even cancer.

Written By Mark Poznansky, MD, PhD, FCRP, FIDSA  

Edited By Jacki Hart, MD

Vaccines in Development: Which are Ready for Prime Time?

Vaccine development for COVID-19 is a fast-moving topic. Private industry, academics, and government agencies are working together at rapid speed to generate viable options for billions of people throughout the world without sacrificing safety or introducing unforeseen risk. The goal, as with any vaccine, is to stimulate your immune system to make antibodies against the SARS-COV-2 virus, thereby protecting you from getting sick with coronavirus. The urgency to control the spread has translated into testing of well-known, theoretical, and brand-new technologies. Brilliant minds are hard at work, around the clock, to not only design and test vaccines, but to also determine systems for distribution and administration to help abate the global crisis

There are hundreds of vaccines in the pipeline in various stages of investigation, including 54 (as of this writing) that have advanced to the stage of being tested on people and 10 in late stage (known as Phase III) clinical testing. As of November 2020, there are two that stand out as close to acceptable levels of effectiveness and safety; therefore, plans for mass production, distribution and administration are also underway.

Pfizer and Moderna Both use mRNA Technology

The news that has grabbed recent worldwide attention include announcements by Moderna and Pfizer/BioNTech that Phase III clinical trials of their mRNA vaccine candidates show nearly 95% effectiveness. Many drained global citizens are starting to imagine solutions for this pandemic. Dr. Anthony Fauci, Director of the United States (U.S.) National Institute of Allergy and Infectious Diseases (NIAID) went so far as to claim that “it’s not going to be a pandemic for a lot longer because I believe the vaccines are going to turn that around.”

There are many caveats and precautions to keep in mind, however, not only with vaccine development and confirmation of efficacy and safety, but also with distribution and administration of the shots.

Vaccine Safety & Effectiveness

While these encouraging results bring us closer to a solution, it’s important to understand what they mean. In clinical trials, such as those conducted by scientists at Pfizer and Moderna, there are two groups of people, neither of whom have been previously infected with COVID-19. Participants are randomly assigned to receive injection of either placebo (consisting of saline water) or the experimental vaccine candidate. The participants, doctors, and healthcare providers administering the injection do not know who received vaccine and who received placebo; this is called a randomized, controlled, blinded clinical trial. In medicine, we refer to that design as the “gold standard” of research because we can rely on the results being scientifically valid, rather than the positive effects being from nothing more than luck or chance. Those who received the experimental vaccine in both the Pfizer and the Moderna studies were 90 to 95% less likely to develop coronavirus than those who received placebo injections. For example, in the Pfizer investigation, 170 people, out of almost 44,000 recipients have contracted the virus to date; 162 of them had received placebo, while only 8 had received the vaccine. 

This is promising and exciting. After many months of being sequestered and feeling secluded, we have legitimate reason to feel hope.

After many months of being sequestered and feeling secluded, we have legitimate reason to feel hope.

Now, Pfizer/BioNTech submitted an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA). The company will continue ongoing research to assess long term immunity (meaning – for how long the vaccine can protect you from contracting the virus), potential negative effects that might occur over time, and ability to confer immunity following exposure to the virus. The last question will explore whether the vaccine is protective if you receive it after you’ve been around someone who has COVID-19. One important element already determined is that it takes roughly 28 days following the second dose of the Pfizer mRNA vaccine until antibodies develop – a crucial step toward conferring immunity. 

Moderna also announced progress on their vaccine, which is based on a similar genetic platform and suggests excellent rates of potential protection.

Vaccine Distribution & Administration

As rates of infection in parts of America and Europe approach their highest levels, everyone eagerly awaits the release of this vaccine. Once authorized by the FDA, public distribution will be complicated and will limit return to our pre-pandemic lives, as will outstanding questions about safety and effectiveness. 

Widespread vaccination in America is still many months away. We must remain vigilant, continue to do everything in our individual and collective power to slow the spread of the virus. Wearing masks, physically distancing, avoiding social gatherings, and practicing hygiene remain the mainstay for stopping the spread of COVID-19 and saving lives. This will be the case for a significant period of time, even after a vaccine is available. Dr. Fauci estimates that high-risk Americans and healthcare workers will be among the first recipients of the vaccine. Ambitious estimates suggest that a sizeable proportion of the U.S. population will receive the vaccine by mid to late spring. But, Dr. Fauci warns, such a “guesstimate” assumes that everything proceeds without setbacks, mistakes, or unanticipated risks.

But, Dr. Fauci warns, such a “guesstimate” assumes that everything proceeds without setbacks, mistakes, or unanticipated risks

Concerns have also been raised about how Pfizer will manufacture and ship the vaccine to hospitals and pharmacies across the globe. Pfizer is manufacturing the vaccine in Kalamazoo Michigan and in Belgium; for Americans, the majority of vaccine doses will come from the Great Lakes state. It is up to federal and state governments, however, to decide to whom to appropriate the doses and the number to request. As mentioned, the vaccine preparation uses mRNA that, once inside your body, enters cells and is coded to produce a protein that mimics spikes on the outside of the coronavirus. These spike proteins “trick” your immune system into responding to this foreign entity as if it were coronavirus. 

The mRNA needs to be kept at temperatures well below zero (more specifically, negative 70 degrees Celsius, which is equivalent to negative 94 degrees Fahrenheit); otherwise, the vaccine will denature (fall apart) and be rendered ineffective and unusable. Pfizer has designed reusable boxes filled with dry ice to keep the vials of vaccine cold enough, and shipping companies, including UPS and FedEx, have designed special compartments to send and deliver the vaccine vials. These special containers hold between 1000 and 5000 vials. 

One potential advantage of the Moderna candidate, which relies on similar mRNA and, therefore, still requires cold storage, is that the temperatures needed for this vaccine to stay stable up to 30 days resemble standard refrigerators and freezers available in pharmacies and hospitals.

Many details are yet to be determined, including that Pfizer reports the plan to ship 50 million doses in December. Twenty-five million of those vials are slated for distribution in the U.S., while the other 25 million will go to other countries. That means that 12.5 million Americans can be vaccinated during this first round, since each person receives two doses, three weeks apart. 

12.5 million Americans can be vaccinated during this first round, since each person receives two doses, three weeks apart. 

Meanwhile, the Bill & Melinda Gates Foundation is at the forefront of global distribution, working with international partners to both quickly develop the second generation of vaccines more suitable for low and moderate income countries and prepare systems for distribution. GAVI, Vaccine Alliance and Coalition for Epidemic Preparedness Innovations (CEPI) are co-leading the efforts of the Access to COVID-19 Tools (ACT) Accelerator to ensure equitable access to COVID-19 tests, treatments, and vaccines. As Melinda Gates says “COVID-19 anywhere is COVID-19 everywhere.”

As Melinda Gates says “COVID-19 anywhere is COVID-19 everywhere.

Distribution Within States’ Purview; But Dollars Fall Short

In the U.S., the logistics of vaccinating and tracking millions of citizens will be left largely to state governments. The Centers for Disease Control and Prevention (CDC) in the U.S. has committed to providing 340 million dollars to the states for these distribution efforts; however, local health departments anticipate much higher costs and have requested another 8.4 billion dollars from the U.S. Congress to adequately and appropriately fulfill this duty. Comprehensive online systems are necessary to keep track of who has received vaccinations. Insufficient funding will slow down the rate of vaccination, especially among citizens who are hard to reach, as well as the process of following who has received their first and second doses. States with large rural populations pose particular challenges for the administration of the vaccine due to the cold storage requirements.

States with large rural populations pose particular challenges for the administration of the vaccine due to the cold storage requirements.

Each of Us Has a Role in Curbing COVID-19

Another problem involves potential resistance to taking the vaccine. There is a worldwide movement of anti-vaxxers, which is based on false data and amplified by social media. Plus, others feel some degree of skepticism because of the speed with which the vaccines are being developed. 

But, as Kavita Patel, MD, a prominent physician and public health expert, points out “vaccines don’t save lives; vaccinations do.” 

Kavita Patel, MD, a prominent physician and public health expert, points out “vaccines don’t save lives; vaccinations do.”

Lessons from the Past

When Elvis Presley was vaccinated on national television in 1956, the polio immunization rate among teens skyrocketed and incidents of polio went down by 90% in just four years. History shows that when prominent Americans, especially from marginalized or high-risk communities, use their platforms to lead by example, people pay attention and heed their advice. Nowadays, those messages can reach far and wide through social media influencers, when first vetted by public health experts. 

Many questions remain unanswered and unexpected challenges will arise along the way. The aim is for scientists and authorities to work hand-in-hand to mitigate polarization and to not only produce safe, effective vaccines but also readily distribute and administer them as swiftly, efficiently, and equitably as possible. 

In the meantime, our job as citizens remains to limit the spread of COVID-19 even after the vaccine is available and distribution has begun. This virus will circulate in the population for a long time to come. Like a mantra, we say again and again:  wear masks, physically distance, avoid social gatherings, and practice hygiene. Plus, while availability of testing has improved, progress is still needed for widespread application in the U.S. and receipt of rapid results. As we face the last quarter of the year since COVID-19 was identified, we still need to set testing as a top priority by enhancing supplies and, perhaps, the possibility of self-administered home testing. 

Written By Rohan Prabhu & Jacki Hart, MD

Isolated Elderly and Stir-Crazy Teens Form Real Bonds, Virtually

My Covid Story

Older adults are at high risk for severe consequences from COVID-19. While this necessitates self-isolation to help mitigate spread and reduce their chances of contraction, the ensuing seclusion is not without its own health risks. The National Academy of Sciences discovered that social isolation and loneliness increase the risk of anxiety, depression, and even premature death in the elderly. Not everyone who is socially isolated (defined as lack of social connections) is lonely and not everyone who feels lonely is socially isolated. Elderly individuals are at higher risk for loneliness and/or social isolation because of factors like living alone, losing friends and family, having a chronic illness, or experiencing hearing loss.

Whether experienced together or separately, loneliness and social isolation are referred to as “poor social relationships,” which increase the risk of heart disease by 29%, stroke by 32%, and dementia by 50%. Among people with heart failure specifically, loneliness was linked to a 4-fold increase in the risk of death, a 68% increased chance of hospitalization, and a 57% rise in emergency department visits.

Disrupted Routines Replaced with Distanced Connections

Many elderly individuals have limited social contact, often restricted to places of worship or community centers. Even routine public encounters in local businesses like grocery stores, pharmacies, or coffee shops are no longer available to the same extent, due to protections set in place against COVID-19. In addition, those who lack close friends or family, or who had relied on care from either paid caregivers or voluntary services, as well as those who were already isolated, are at an increased risk of loneliness and associated health concerns.

Seeking to alleviate the physical and emotional isolation of at-risk seniors, Rabbi Marcia Plumb of Congregation Mishkan Tefila in Brookline, Massachusetts developed the Silverlining Buddy program to replicate volunteer and visiting programs that existed prior to COVID-19. This virtual program is an intergenerational collaboration, managed by Wendy Handler, designed to foster relationships between seniors and college students or young professionals. Understanding the difficulty that technology can present for some seniors, Rabbi Plumb conceived the program as an old fashioned, basic pairing of individuals through telephone contact. With the support of Combined Jewish Philanthropies (CJP), a non-profit organization in Boston, they are expanding the program to use Zoom or other technologies.

The program has successfully matched more than 100 buddy pairs

The program has successfully matched more than 100 buddy pairs, based on community needs and availability. Young adult volunteers undergo basic training and then typically connect with their senior buddies at least once a week. They discuss a myriad of topics ranging from personal life stories to politics to the science behind COVID-19. While the program was initially designed to help reduce loneliness among older adults, Ms. Handler says the program has shifted into more of an equal relationship where the young volunteers get just as much out of the experience as the older adults.

Unexpected Life Parallels

Rosalie, a senior buddy, became involved in the program through her synagogue; she thought it would be fun to talk to someone from a younger generation. She and her buddy, Nikki, a college junior, have a lot in common. Both grew up in Brooklyn, New York. Both had family members who were Holocaust survivors, and they share similar political views. Conversations between Rosalie and Nikki run the gamut from their personal lives, including gardening (a hobby of Rosalie’s) and travel to politics and science. They even exchange recommendations for good books and show each other photos over facetime. Rosalie likes hearing about changes in Brooklyn and she also now appreciates how the pandemic has imposed limitations on the younger generation still in college too. Rosalie says that she and Nikki never run out of topics and that her young companion asks thoughtful questions that make her reflect. “It’s comforting to talk to [Nikki] and hear about her life,” Rosalie said. “I think [the Silverlining Buddy System] is a very interesting and fun concept and perhaps, even after COVID, it would be good to keep it up.” 

Nikki became involved in the program through Companions to Elders, a community service program she helps coordinate for her university. Nikki relays that “[the experience] has made me insert more perspective into my day to day life, because it’s so easy to get absorbed into the bubble of college, when I’m at college, or of my childhood bedroom which I’ve been trapped in for six months! Leaving that world to talk to someone who is pretty far out of that environment gives me more perspective. Takes me out of my head.”

Leaving that world to talk to someone who is pretty far out of that environment gives me more perspective. Takes me out of my head.”

Emma, another student buddy, is a college senior majoring in biology. She said that volunteering has given her the opportunity to empathize with someone older and wiser, and helped broaden her view of the world. “If Marylin (her buddy), who has lived through many ups and downs in history still has hope that we’ll go back to normal day to day life, and is still enjoying each day; I think that just shows that we all should be thankful for what we can do and what we do have during this time.”

The Silver Lining Buddy System offers a unique opportunity that provides a meaningful connection during a time when many of us are feeling disconnected. It should serve as a role model to spawn similar programs. 

Written & Reported by Giovi Hersch
Edited by Dr. Jacki Hart

COVID Poses Unique Challenges for International Students, Minseo Reflects

My Covid Story:

Minseo shares her story as an international boarding student from South Korea at the start of the COVID-19 pandemic. Early on, when things looked worse in her home country, she and her parents grappled with what made more sense: staying in the United States (U.S.) or going home. Thankfully, Minseo made the decision to return to her own country because the statistics quickly began to turn.

COVID Poses Unique Challenges for International Students, Minseo Reflects

Mid-February 2020, I sat at a table in my school’s grand dining hall and received a call from my parents. They expressed concerns (that I shared)  about my going home to South Korea over the upcoming spring break. At that time, Korea was experiencing hundreds of Coronavirus cases each day, with numbers continuing to rise. Despite our initial trepidation, I soon found myself bundled up at the Incheon Airport waiting for my parents to pick me up to drive home, along with my luggage, hand sanitizers, ethanol spray, and three packs of KF94 masks — including the one I was wearing.  

Spring term of my freshman year was a mess, but I felt relieved about the early decision to return to my family before strict travel restrictions ensued a couple weeks after my arrival.

Since the outset of the pandemic, I’ve been grateful for South Korea’s well-designed healthcare systems. For example, anyone, including foreigners, were reassured that they could enter the hospital and receive treatment if they tested positive for the virus. They also  quickly established systems and processes that halted the spread of COVID-19 and reversed that initial spike, including successfully stopping a recent outbreak that could have led to a resurgence.

Pros and Cons of Remote Learning

Meanwhile, the pandemic was heating up in the U.S. causing nationwide school shutdowns from March through May 2020. Now faced with learning from home unexpectedly during my spring term, I took the time to explore areas that I don’t normally have the luxury to examine due to a packed daily school schedule. I researched architectural design like the Burj Khalifal; watched Netflix movies, COSMOS, and quantum mechanic documentaries; and reached out to teach coding to students. I tried to make the best of what could be done during self-quarantine.

I took the time to explore areas that I don’t normally have the luxury to examine

However, as an international student in South Korea, I faced many difficulties during that semester. Due to the 13-hour time difference between the Eastern Standard Time (EST) operations for my school courses and Korean Standard Time (KST), I grappled with the arrangement of my schedule: Should I wake up early before dawn or should I just stay up through the night for my 4 AM class and then sleep until noon?

Should I wake up early before dawn or should I just stay up through the night for my 4 AM class and then sleep until noon?

With continual disruption to my sleep-wake cycle, and countless sleepless nights, during spring term and into summer break, I never settled into a routine, healthy sleeping pattern. Instead, I struggled through sporadic intervals of disjointed sleep and rest. When I got the chance to connect with friends from either South Korea or the U.S. over video calls, we lamented about our collective fatigue, mental stress, and interrupted sleep schedules. It was clear that many international, as well as regional U.S. students, were having similar troubles.

COVID-19 Sparks Innovation

While the COVID-19 pandemic has brought much suffering, it has also brought some pockets of hope and opportunities

While the COVID-19 pandemic has brought much suffering, it has also brought some pockets of hope and opportunities, especially in terms of  development in technology and bioengineering. Coronavirus has become a catalyst for scientific initiatives like telemedicine. Along these lines, many inspirations have stemmed from college students and fellow high schoolers who have been discovering solutions to combat the Coronavirus, such as COVID-Map and informative apps. As a problem-solver myself, I wanted to contribute too with my own knowledge about software programming and product-creation.

Together with a close friend from Korea, we designed the DreamCatcher Lab team, entered an artificial intelligence (AI) competition called POSCO 2020 AI Challenge; as participants, we began to develop a smart app and product in order to help patients with partial and chronic insomnia, and anyone having trouble getting a good night’s sleep in general. My own disrupted pattern, as well as many of my friends and schoolmates, was the impetus to search for a solution to maintaining good sleep cycles. In the span of three months, we successfully created the DreamCatcher app with pink noise music therapy, a wireless device, and a novel AI technique, called ElectroCardioGram (ECG) estimation from a PhotoPlethysmoGram (PPG) wave, to help monitor user’s sleep. Ironically it felt like I had insomnia from staying up nights debugging the program; but it was amazing to see the idea become a reality.

Trying to Make Sense of the Inconceivable

As a quantum mechanics enthusiast, I’ve learned to appreciate the unruly subatomic universe as “orderly chaos” — sensible things made up of objects that follow senseless rules. Trying to decrypt the phenomena and reach mathematical proofs, leads to one of two opposite places: either scientific properties with definitive answers or somewhere even more surreal.

The past several months have been the latter: bizarre,  unimaginable, even incomprehensible. As the pandemic and public health crisis impacts all of us globally, cyclic relapses of racial discrimination — George Floyd, Breonna Taylor, David McAtee — persist in a fundamentally-corrupt system. Asian gaslighting and violence serve as another inconceivable reminder. Add to that, burning infernos, first in Australia then across the West Coast of the U.S. like some blistering plague. The events collectively unfolding like a morbid tale or tragic playbook. Is there order to this chaos and destruction?  Worse yet, these outcomes probably won’t remain confined to the year 2020.

How Does this Relate to My School?

Following a couple weeks of online learning from Korea, my school is (at least tentatively) reopening for the start of fall term. I’ll be flying back to campus in October. Despite the degree of disaster and upheaval, I’m relieved to see changes in the school’s approach. We now have an Anti-Racist Workshop period in the weekly schedule and have regular talks and interviews about race during assembly. 

Overall, the concept of online zooming for math or even orchestra class isn’t as awkward anymore. With back-to-campus protocols, I’m curious (and a bit nervous) to learn whether the school’s meticulous planning to prevent Coronavirus outbreaks will prevail. Routine dormitory sanitizations, check-ups, food pick-ups and social distancing, meeting restrictions, 24/7 health center operations, and more comprise the plan. Upperclassmen already moved into the school dorms several weeks ago.

Honestly the precautions aren’t nearly enough to put my mind, nor my parents’ and friends’ minds, at ease.

Honestly the precautions aren’t nearly enough to put my mind, nor my parents’ and friends’ minds, at ease. The thought of an influx of hundreds more students to the campus and positive cases continuing to pop up in nearby towns worry me. 

Despite these legitimate concerns, I’m committed to trying, along with my peers, to focus my thoughts and energy on continuing to create, innovate, and solve problems. Taking my cues from visionaries, scientists, activists and classmates, I’ll thrive to make sense of the situation, and to discover solutions. Creating and inventing, like I did with the DreamCatcher, offers the possibility of practical solutions and provides a sense of hope. 

“The past is our present,” as the saying goes. Unravelling the twisted strings and determining viable solutions, from global warming to the battle against new, more-resilient viruses to centuries old and ensconced problems like racism, may sound insurmountable. But, if we’ve learned anything from this pandemic, we definitely ought to try. 

Reported by Anoushka Mahendra-Rajah
Written by Minseo Kim
Edited by Dr. Jacki Hart

A Thin Cloth Line: Debunking the Myths Surrounding Masks

The use and effectiveness of masks have been questioned by those who do not believe they are necessary – often referred to as “anti-maskers.” Some argue that masks don’t properly filter the virus and others claim that they restrict proper airflow. These positions are based on pseudo-science and have led down a divisive, if not dangerous, path to rejecting the wearing of masks. Research and analysis consistently support that use of masks slows the spread of COVID-19 and saves lives. 

One interesting way that the Center for Disease Control (CDC) recently addressed these concerns was to evaluate, and then publish a scientific report, detailing how masks and face coverings were able to contain the spread of COVID-19 for a couple of hairstylists while interacting with their clientele.

Two Symptomatic Hairstylists Avoid Spreading COVID-19 to Clients

Conducted in Springfield, Missouri, a real world experience presented an opportunity to assess whether masks successfully prevented the spread of COVID-19 from two hairstylists to 139 of their clients. Both the hairstylist and the person receiving a haircut wore masks or face coverings during the appointments. Each stylist wore double-layered cotton face masks. The hairstylists were both symptomatic while seeing these 139 clients (mean age of 52 years and all willingly seeing the stylist without knowing their COVID-19 status). Despite having some typical, yet mild, respiratory symptoms, like cough and congestion, neither hair stylist had been tested for coronavirus when they saw these particular clients. Haircut appointments lasted for an average of 19 minutes. 

Once the hairstylists learned that they tested positive for COVID-19 (after 8 days of symptoms for one of the stylists, and 5 days of symptoms for the other), they stopped seeing clients  and self-quarantined. The Greene County Health Department in Missouri contact-traced all 139 clients that were exposed to the stylists, recommended they quarantine for 14 days, and offered free testing to all. Of the nearly 50% who agreed to receive a nasopharyngeal swab test, all of them tested negative for COVID-19. 

There were also no respiratory symptoms reported by any of the 139 clients, or their secondary groups, such as family and friends following exposure to the hairstylists. The county health department was able to interview 104 of the identified clients, which allowed for supplementary data to be acquired too, such as age, duration of appointment, and type of face covering used. The only people identified who developed COVID-19 symptoms and/or tested positive for the virus were the immediate housemates of one of the hairstylists. 

Through the use of face coverings, two stylists who were both symptomatic and COVID-19 positive did not transfer the virus to their clients during their respective appointments.

This study bolsters other scientific evidence corroborating the use of face coverings, whether homemade or surgical, in slowing the spread of COVID-19. It is remarkable, and reassuring, that the use of simple face coverings prevented the transmission of the COVID-19 virus from two symptomatic hair stylists to their clients in close proximity.

This study bolsters other scientific evidence corroborating the use of face coverings, whether homemade or surgical, in slowing the spread of COVID-19.

The Data Have Been Consistent

The results of this study parallel previous observational data on the effectiveness of masks. An analysis of “194 countries… found a negative association between duration of a face mask [and other] polic[ies] and per-capita coronavirus-related mortality.” This means that the longer that a country has had a mask wearing policy, the fewer overall deaths and the lower the mortality rate in that country. In addition, countries that did not recommend face masks saw a COVID-19 related mortality rate increase of “54.3%…compared with 8.0% for countries with masking policies.”

An updated count from this same research, along with assessment of other protective measures, compared countries with mask mandates to countries without mask requirements. That gap in mortality rate expanded even further: in countries where citizens wear masks, the per capita coronavirus mortality, since the start of the pandemic, increased by almost 16% each week compared with 62% per week in countries where citizens do not wear masks. In America, this likely translates into parallel differences from state to state — where mask wearing is standard, regulated, and/or culturally accepted versus those where they are not. 

Collectively, these studies affirm that face masks effectively slow the spread of the virus and should be used as a deterrent for the current, and possibly future, pandemics. If you still have friends or family members who don’t believe or consider themselves “anti-maskers,” try sharing this video from Public Broadcasting Service (PBS) scientists called “It’s Ok to be Smart.” PBS explains why and how masks work to protect all of us. Together, we can debunk mask myths, protect one another, and curb the spread of COVID-19. 

Written by Robert Shepard
Edited by Dr. Jacki Hart

Teen Initiatives During COVID-19: Young Adults Support Their Communities

My Covid Story

As the pandemic spread, forcing schools and businesses to close in April, two teenagers in Massachusetts found themselves with time on their hands and a pressing urge to use their skills to help others. With 80% of COVID-19 infections presenting as mild or asymptomatic, masks to prevent the emission of potentially infected particles is crucial to slowing the spread of this disease. Noah Lang (high school class of 2021) and Izzy Klein (high school class of 2020 /college 2025) founded businesses and nonprofits with the aim of making masks as accessible as possible to people in their community. Lang founded the nonprofit Masks4Mass to procure and donate masks to organizations like the Boston Rescue Mission, Margaret Fuller Neighborhood House, and high schools in his area as they have been preparing to reopen. Klein started Masks By Izzy to offer deliveries and pickups of her affordable hand-sewn masks and donate proceeds to the Greater Boston Food Bank.

Recently, talked to Noah and Izzy to better understand what inspired each of them, how they remain motivated, and ways that their ventures have helped others.

Getting Started

Noah: I came up with the idea of founding this nonprofit, Masks4Mass, after I realized how difficult it was to obtain masks, especially early on in the pandemic. I was brainstorming ways that I might be able to help my community and facilitate the reopening of schools. I wanted to do something that was different and meaningful. As a result, I founded this nonprofit with the hope of ultimately contributing to halting the spread of COVID-19

Izzy: I’ve been sewing since 4th grade through after school classes with a friend. And I’ve always loved creating things, helping people, and trying to make things accessible. My background is in political and community organizing, and communications. With those things in mind, I wanted to find a way to help people right now — with the immediate crisis. Being able to produce something that gives back, that’s functional, and that’s keeping people safe at the same time that it also benefits my community was my goal.

Initial Steps

Izzy: I started sewing and the first few masks weren’t great, but I definitely had a foundation. I started giving them to family and friends, and they really liked them. I originally did an order form and I would get crazy high demand every week – like 40 orders. It was getting a little hard to keep up because I would take the orders on Monday, work on them throughout the whole week, and arrange for pickup or delivery on Saturdays. I realized that with the growth, it would be good to have a website. Now, we are in the process of making my site not only a place to buy masks but also other things made by different members of my community. In the meantime, given that college for me is now online, I decided to take a gap semester to work on this. I’m hoping to expand; right now we’re doing a lot of bigger orders for smaller businesses and for family events and stuff like that. It’s been really good and I’ve definitely enjoyed being able to meet different members of my community. 

Noah: I’m definitely planning on continuing this initiative past the summer. As long as the  pandemic continues, I want to help and try to find ways to make an impact on our community. I haven’t really set an ultimate goal because I see this as an ongoing process. My biggest goal is to get masks to schools because this is a vital aspect to reopening. If all students were able to have access to masks and personal protective equipment I think opening schools would be a lot easier. However, it’s been challenging because public schools haven’t been very responsive. I’ve been reaching out to people that I already know first: parents of some of my friends, coworkers of my mother and my father, people from my own school, etc. I’ve set up a donation page on my website. That way, even people who don’t know me personally are able to contribute to Masks4Mass. 

Growing Process & Pains

Izzy: Seeing people wearing their masks definitely makes me super happy. It’s a lot of young families who have been telling me that the masks that we make are really affordable. A lot of people who placed orders when the idea was just being formed said things like, “You know, your mask is the only mask my kids will wear because your kid size fits so well.” That is super awesome and gratifying to hear because I know it’s really hard to work with younger children on this. A lot of wonderful friends from school have been delivering masks for me as well, so I can spend more time sewing. I have received help with cutting fabric and taking orders from different YMCA’s. It’s gratifying to have  a lot of friends and family helping out.  

Noah: One of the greatest challenges with this learning process is that it’s the first time that I’ve ever formed a nonprofit. I had  to learn how to incorporate my nonprofit with the Commonwealth of Mass. Also, in order to receive tax exempt status from the Internal Revenue Service (IRS) I needed to research and learn how that  works. A smaller-scale challenge has been, again, that public schools have been significantly less responsive than private schools, which is somewhat frustrating. But I’m continuing to try to work my way around that. I’m guessing it’s because they have additional regulations. Another obstacle I’ve had is that some of the masks [we’ve secured have been] pretty low quality. They don’t really seal or fit your face well which allows for openings around the sides of the masks. That kind-of defeats the purpose of the mask, of course. Others are just bad quality in general and that’s something I have to work my way around, too. I have been buying a sample batch of masks before making a bulk purchase. That seems to help  solve the quality control problem.

I have been buying a sample batch of masks before making a bulk purchase. That seems to help solve the quality control problem.

Lessons Learned

Noah: I think one of the things that is extremely important to me and a main takeaway is the importance of community and the willingness to help others. Prior to this, a lot of the work I had done for my community was with my school; this has felt different because it was organic and not a requirement. I think that’s something that I’m trying to tap into — sympathizing with others and willingly helping them out. This organization has helped me solidify that mindset. As a personal thing, the formation of this nonprofit has taught me a lot about the process of how you incorporate a non-profit into the Commonwealth, and the different steps that you need to take in order to have a legal nonprofit and get tax-exempt status. Another aspect that has also been interesting is accounting. Over the past couple months, I’ve done a lot of accounting because of the fundraising. It seems likely that I’ll use many of these skills later on in my life and it’s [an interesting opportunity] to start learning them now. Overall, I think that running this nonprofit is not only a great way to support my community. It has also taught me a lot about nonprofits in general and the importance of taking an initiative to help others.

Izzy: We’ve never really lived through a time like this in recent modern history. So, I think it’s super important to make sure that we are being intentional about helping others. I feel very privileged – which is not necessarily a great feeling – but I think it also gives me this kind of responsibility to give back, because I have the resources to be able to do that. It’s time to just make sure that we are all being mindful with our choices and with our actions. If you are in a position where you’re comfortable right now, and you don’t really have that much worry in your life, start thinking about ways that you can give back. Whether it’s helping at a shelter or food pantry, or donating somewhere, we need to make sure that we are constantly asking ourselves: What are small things that we can do that, in turn, will have a positive effect on society?

Reported by Anoushka Mahendra-Rajah
Edited by Dr. Jacki Hart

White House Touts Old Therapy for New Virus

Convalescent plasma (CP) is not a new therapy, but it’s gotten new attention. For illness that has progressed to respiratory distress, physicians in hospitals have prescribed convalescent plasma for COVID-19 patients, along with other treatments like steroids and antiviral medications that are generally well established for this clinical scenario from similar infectious agents. Because of both theoretical benefit and observational success, studies have begun to emerge about the application of convalescent plasma for COVID-19 specifically. With early encouraging results suggesting improved survival rates for tens of thousands of individuals, the White House administration urged the United States (U.S.) Food and Drug Administration (FDA) to establish emergency use authorization (EUA). Despite the preliminary success, this move remains controversial because the usual degree of research scrutiny has not been applied to convalescent plasma for COVID-19. Studies are ongoing.

Proponents say convalescent plasma has been around for a long time for similar purposes, what could be the harm? (Well – think hydroxychloroquine…) Skeptics say the move is premature. The middle ground would have been to continue in the previous capacity of FDA investigational (also called compassionate) use. That allows doctors to make informed clinical decisions to use CP when the patients’ circumstances warrant, with documentation and agreement that the patient is aware of the experimental nature of the therapy, and with meticulous tracking of many details that would become clinically relevant and inform well-substantiated application of the treatment as we move forward. 

Now, some experts worry that the EUA might jeopardize research. Having the medication readily available for this purpose may translate to fewer people enrolling in studies since doctors can obtain the drug for patients without requesting the added demands of participating in a clinical trial. Given the positive publicity about convalescent plasma, patients may not take the chance of being assigned to a placebo group and, thus, not receive the therapy. The EUA may also lead to diminished tracking which helps delineate important details regarding the treatment, like dosing and timing of administration as well as potential risks, side effects, and negative reactions.

How does Convalescent Plasma Work?

The idea of convalescent plasma is to gather blood from patients who have recovered from the infection and, thus, developed antibodies that might confer immunity to someone who currently has the illness. In theory, the antibody-rich blood product should help patients recover faster from COVID-19. Since there is no confirmed effective treatment for COVID-19, the idea of boosting patients’ immune response to the virus seems worthwhile.

The therapy has been around since early in the 20th century and has been used successfully for other viruses, including hepatitis, mumps, measles, rabies, polio, and the 1918 influenza pandemic. More recently, it’s even been used for H1N1 flu, Ebola, and previous coronavirus outbreaks like Severe Acute Respiratory Syndrome -1 (SARS-1) and Middle Eastern Respiratory Syndrome (MERS). However, it remains unclear whether convalescent plasma adds benefit to standard treatment. The way to determine this involves studies using a rigorous design known as randomized controlled clinical trials (RCTs) for hospitalized patients with COVID-19.

Without such scientific analysis, many questions remain unresolved about the proper way to administer the therapy

Without such scientific analysis, many questions remain unresolved about the proper way to administer the therapy – including exactly who will benefit, at what stage of the COVID-19 infection, and what dose confers protection. 

Data from Chinese researchers suggests benefits like xray resolution of lung infections from COVID-19, a reduced viral load, and improved survival. However, the data is extremely limited, including that that study was discontinued due to low rates of enrollment and lack of added clinical benefit from convalescent plasma. There are several assessments going on currently in the U.S., including through the University of North Carolina (UNC) and an expanded (again, called compassionate) use program led by the Mayo Clinic in Minnesota. The latter is from where much of the information about CP use in COVID-19 patients has been derived to date. 

In the meantime, under what appears to be possible pressure from the White House Administration, and against the advice of some prominent experts, the FDA issued the EUA on August 23rd, 2020 for convalescent plasma. 

Given the change in FDA status, there has been a surging interest from hospitals continuing to struggle with high numbers of people with COVID-19. This has translated to accelerated demand for convalescent plasma. Blood banks around the country are shipping CP to states like Florida, Texas, Tennessee, Mississippi, Missouri, and California. Organizations leading these efforts include the Red Cross and America’s Blood Centers.

If you’ve recovered from coronavirus and test positive for COVID-19 antibodies, you might be eligible to donate convalescent plasma; the FDA explains.

If you’ve recovered from coronavirus and test positive for COVID-19 antibodies, you might be eligible to donate convalescent plasma; the FDA explains. Even one donor can benefit three to four patients with matching blood types. 

Written By Rohan Prabhu & Jacki Hart, MD