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Peers and Perspectives

1rem

, where we delve into some of the social factors that create and widen healthcare disparities.

Social determinants, a legacy of distrust, and inequities have all been challenges for people of color in the delivery of health care. And these factors have translated to the administration of 

The university hosts the biggest vaccination site in its county, San Bernadino. However, there is low representation of Black vaccinees. Abdul-Mutakabbir and faculty at Loma Linda worked with leaders from local Black churches to get the word out and communicate about the availability and benefits of the COVID-19 vaccine.

“From February 1 until April 30, 2021, 24,808 individuals were vaccinated in the LLU mass clinic with a first dose (Pfizer or Moderna) or single dose (Janssen) of a COVID-19 vaccine, however, only 908 (3.7%) were Black vaccinees. Contrastingly, the LLU remote site clinics vaccinated 1542 individuals with a first or single dose of a COVID-19 vaccine. Of those vaccinees, 675 (44%) were Black,” Abdul-Mutakabbir and coauthors wrote in their poster.

Along with protection against COVID-19, Abdul-Mutakabbir makes the point that preventative measures such as vaccines can help avoid hospital stays and subsequent health care associated infections and antimicrobial resistance. She believes vaccination goes hand-in-hand with antimicrobial stewardship.

Hear what vaccine equity means to Abdul-Mutakabbir, and the vaccine drive in which she was involved.

Missed Episode 1 of Contagion Community? 

Listen in on the conversation and feel free to offer your feedback on this episode, interest in participating in the podcast, or suggest ideas for future episodes. Please email your correspondence to Nina Cosdon: ncosdon@mjhlifesciences.com

In this latest episode of Contagion Community, we interview Dr. Jacinda Abdul-Mutakabbir about vaccine equality vs vaccine equity as well as her experience on a COVID-19 vaccine drive to increase vaccinations in communities of color.

Vaccine Equality vs Equity with Dr. Jacinda Abdul-Mutakabbir

’s new podcast, Contagion Community, where we delve into some of the social factors that create and widen healthcare disparities.

In surveying our audience, 75% of respondents viewed health equity as a major issue within medicine. Infectious disease often disproportionately occurs along the lines of ethnicity, race, class, gender, education, sexual orientation, geographic location, and more. The entwined nature of healthcare inequity and social factors inhibit us from examining infectious disease objectively, which is why Contagion Community spotlights underserved populations.

Through interviews with experts, we will offer insights into the issues associated with healthcare inequities and examine the strategies being deployed to overcome them.

Contagion Community is a marriage of major conversations occurring in hospitals, labs, academics, and communities.

Vaccines have the power to save lives. However, what happens when they're not distributed equitably?

Today, Associate Editor Nina Cosdon speaks with Leonard Friedland, MD, vice president of Scientific Affairs and Public Health Vaccines at GlaxoSmithKline, about vaccine disparities in the US and around the world.

Enjoy the program and stay tuned for our next episode!

In this first episode of Contagion Community, we interview vaccine research scientist Dr. Leonard Friedland about vaccination disparities in the US and around the world.

Vaccine Inequity With Dr. Leonard Friedland

This interview and episode was recorded and produced prior to the November 16 announcement that 

Moderna's vaccine candidate mRNA-1273 was associated with 94.5% efficacy

 in preventing COVID-19 in preliminary phase 3 COVE trial data. Though the candidate and the mRNA platform is discussed throughout the podcast, more updated coverage of mRNA-1273 will be made available on ContagionLive.com throughout the coming weeks.

In matter of 2 weeks, a series of significant clinical, public health, and otherwise factors greatly influenced the current state of 

From promising preliminary phase 3 data from Pfizer and BioNTech, to record surges in new cases and hospitalizations across the US, and to a Presidential election laden with public health policy implications, the makeup of COVID-19 pandemic response is entirely different from what it was weeks ago.

It is only bound to change even more greatly in just a couple more weeks. Before the US Food and Drug Administration (FDA) is able to weigh on the potentially first COVID-19 vaccine to submit an Emergency Use Authorization (EUA) and kick off an unprecedented distribution and real-world monitoring process, it’s crucial to assess where things stand now, and what’s coming up.

This week’s Vaccine Race podcast features an interview with William Schaffner, MD, professor of Preventive Medicine and Medicine at the Vanderbilt University Medical Center.

Schaffner discusses his own impression of the new Pfizer preliminary data for candidate BNT162, whether the current US rate of 150,000-plus new daily cases could pressure the FDA to further expedite a vaccine, what vaccine distribution, storage, and immunization will entail, and what a new administration would (or would not) mean for COVID-19 response and vaccine development.

The Vanderbilt Professor of Preventive Medicine shares thoughts on the first potential COVID-19 vaccine, at a time of record new daily cases.

Vaccine Race: The Pfizer Vaccine with William Schaffner, MD

, as the global-scale infectious disease meeting has been forced to resort its comprehensive clinical agenda to a virtual format due to 

As an acknowledgement to the great burden of COVID-19—and in spirit with the meeting’s great collaborative efforts—the first 24 hours of the annual meeting are dedicated to discussions around the pandemic, titled “Chasing the Sun.”

 will provide around-the-clock IDWeek 2020 coverage over the next days, we kick off our content in a similar fashion: the second episode of our limited series podcast Vaccine Race.

In this episode, senior editor John Parkinson sits down with Mei Mei Hu, co-chief executive officer of vaccine development company Covaxx, and honorary member of Time Magazine’s Next 100 List of 2019.

Covaxx’s investigational COVID-19 vaccine, UB-612, is the first multitope peptide-based vaccine capable of activating both B-cells and T-cells.

about her company and its creation of this interesting candidate, and provided some firsthand insights into getting a vaccine through the development process.

Stay tuned for more IDWeek 2020 content, and a new Vaccine Race episode, throughout the week.

ID Week

A vaccine developer joins for a firsthand discussion on the development, research, and distribution process.

Vaccine Race: Mei Mei Hu on Developing, Researching a COVID-19 Vaccine

Findings indicate that while the severity of health impairment decreases over time, 18% of unvaccinated participants still experience symptoms up to 2 years after infection. 

Long COVID Lingers: Prolonged Symptoms and Recovery Patterns 2 Years After COVID-19 

How does the diagnosis rate of mental health disorders after COVID-19 compare to that of other respiratory infections?

The Hidden Impact of COVID-19: Deterioration of Mental Health After Hospitalization

A new documentary looks at dealing with the condition long-term, and serves as a microcosm for how people suffer through chronic conditions and diseases, and may not get the help they need.

Dealing With Chronic Lyme Disease, Navigating the Health Care System

The FDA's decision to approve Abrysvo was based on data from a Phase 3 clinical trial, which demonstrated the RSV vaccine's efficacy, immunogenicity, and safety in adults aged 60 and older. 

 A Milestone in RSV Prevention: FDA Approves Pfizer's Abrysvo Vaccine for Older Adults

Neutralizing antibodies were initially lowest among Janssen vaccine recipients, but this all changed 6 months after vaccination.

What Affects Neutralizing Antibody Durability? A Comparative Study of COVID-19 Vaccines


After 3 years of the pandemic, it is a good time to review what we have learned collectively. Time and some distance from the acute phase of the pandemic offers investigators and those who have studied the virus the ability to evaluate it and its consequences with a longer-term perspective including what we could have done better and how we can apply these lessons for the future. 

Back in early 2020, physicians and other providers were on the frontlines of the pandemic. Many of us remember the videos and pictures of these essential medical personnel coming home from a shift and having to remove clothes and sanitize themselves before coming in to be with their families. They carried risks to both themselves and their loved ones in a time when no one knew the true transmissibility of the virus, and/or how to treat COVID-19. 

“They really were heroes providing the best possible care under very trying circumstances,” Michael Stevens, MD, MPH, FACP, FIDSA, FSHEA, System Healthcare epidemiologist, WVU Health System Professor of Internal Medicine, West Virginia University, explains of those early days.

Stevens presented a scientific session, Preparing for the Next Pandemic: Lessons Learned From COVID-19, at this week’s 

 being held in San Diego.

Although he says COVID-19 care evolved and the work done there was vital in saving lives, he is concerned if we were to face another pandemic. “From a high level, we are not in a great position for another respiratory viral pandemic,” Stevens said. “We certainly have a much better perspective on how we performed and what we would need to do as a country, as a world, to respond better…in the end we need to strengthen our ability to detect these new pathogens when they emerge and we need to strengthen our ability to respond in real time in a coordinated fashion when they threaten us.”

Stevens also says the public health messaging is another vital element that needs to be communicated more effectively. "We have to do something to communicate these messages in the most optimal way that is understandable to the general public.”



 spoke to Stevens at the conference and he provided some insights not only on the past, but considerations for the next potential pandemic.




An epidemiologist offers some insights on what we need to take into a potential next pandemic including infrastructure investment and more effectively communicating messages to the public.

Conferences

Lessons Learned: What the Pandemic has Taught Us


According to the National Institutes of Health, nearly all children become infected with RSV by age five, and approximately 58,000 of them need hospitalization annually. This past fall, RSV cases increased dramatically, and impacted hospital capacity with this patient population.

Although there are RSV vaccines and therapies in clinical trials, there is nothing approved. Both prevention and treatment remain critical, clinical needs, and FDA sees these unmet needs as of significant importance.

In November, clinical-stage biotechnology company, Codagenix, was granted an FDA Fast Track designation for its, an intranasal, live-attenuated vaccine candidate, CodaVax-RSV, for the prevention of respiratory syncytial virus (RSV).

“Though RSV is the leading cause of hospitalization for children below the age of five, there are currently no vaccines approved to protect against this devastating disease. We are encouraged by the Fast Track designation for CodaVax-RSV, which recognizes the vaccine’s unique potential to address this significant unmet need,” Codagenix Cofounder and CEO J. Robert Coleman, PhD, MBA, said in a statement at that time. 
 
The phase 1 dose escalation study of CodaVax-RSV evaluating safety and immune responses in healthy children aged six months to five years is expected to initiate in the early part of this year, immediately after this year’s RSV season. Based on the results of this study, a phase 2 dose confirming study will explore efficacy during the RSV season in 2023-2024.

The company has built its platform around live-attenuated virus vaccines as opposed to viral vector or mRNA-based vaccines using its codon deoptimization platform.

The company also has its COVID-19 intranasal vaccine candidate, which recently entered phase 3 clinical trials as part of the WHO-sponsored studies.

In a wide-ranging interview with 

, Coleman talks about the advantages of traditional live-attenuated virus vaccines as opposed to mRNA-based vaccines as well as updates on their RSV and COVID-19 vaccines.

This live-attenuated investigational vaccine was developed by Codagenix, which uses its codon de-optimization platform for its candidates.

FDA Fast Tracks Intranasal RSV Vaccine

 its first Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for 2023, and the meeting is looking to discuss if the currently available COVID-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward.

One important component that has been sorely missed in understanding virus protection is T-cell testing.  The role T-cells have played in understanding COVID-19 immunity and vaccine response has been limited at best. Measuring T-cell response could help provide a more complete picture of protection after vaccination. 

A growing body of evidence indicates T-cells may be an important correlate for protection and should be considered as an endpoint for vaccine clinical trials and in the development of next generation vaccines and boosters

The ability to determine immunity information in individuals may help to bore down on needed protection against viruses.

“As we've seen with the latest outbreak, T-cell testing is very, very important for long-term immunity,” Virax Biolabs Group Chief Scientific Officer Tomasz George, PhD, said. “So in order for you to get a real picture of how your body is adapted to a virus, or whether you're going to fight off a new virus in the future, it's useful to look at your T cells to say actually, will I mount an effective response if I was to get this virus again, or if I was to get new virus in the future that's kind of maybe similar to a virus that I've had in the past?”

United Kingdom-based Virax Biolabs Group is a biotech company that is focused on the detection and diagnosis of viral diseases, with a particular interest in the field of immunology. 

Virax is currently developing

a proprietary T-cell testing platform, Virax Immune, with the intention of providing an immunology profiling platform that assesses each individual’s immune risk profile against major global viral threats.

The goal is to help individuals track their immune status and provide suggestions to guide their health, and the company expects to do this by augmenting the patient/user experience by launching its Virax Immunity mobile application.

In addition to the aforementioned platform, the company has commercially available tests for COVID-19 and introduced monkeypox and varicella-zoster viruses real-time PCR detection kits earlier this year. 

 spoke to George who offered some insights into why T-cell testing has been limited thus far, provided background on their T-cell platform, and how immune-profiling can work on a larger scale.

Virax Biolabs has developed a T-cell testing platform to develop an immune risk profile against viral threats.

Determining Long Term Immunity May Aid in Understanding Vaccine Efficacy 


DNA-encoded technologies are being used in the development of therapies and vaccines, and can be an alternative to the well-known mRNA platform. The mRNA platform was utilized for both the Pfizer-BioNTech and Moderna COVID-19 vaccines. The DNA and mRNA platforms have multiple differences. For example, in thinking about vaccines, DNA-enabled vaccines require an electrical impulse to push the genetic message into the cell, whereas RNA vaccines do not. 

 instruct cells in the body to produce a protein that induces an immune response.

David Weiner, PhD, The Wistar Institute executive vice president, director of the Vaccine & Immunotherapy Center, and W.W. Smith Charitable Trust Professor in Cancer Research, and his team have been working on DNA-encoded SARs-CoV-2 monoclonal antibodies, and earlier this year they were able to advance their research to a clinical trial.

The research included colleagues at The University of Pennsylvania, AstraZeneca, INOVIO Pharmaceuticals, and Indiana University. This summer they began their clinical trial using this novel COVID-19 antibody delivery approach. 



An important component of any research is to have the financial backing to sustain what can be years of work in the quest to go from bench to bedside. COVID-19 research has been largely shaped by a combination of public-private partnerships to develop everything from vaccines to therapies for the virus.

These partnerships remind everyone that the federal government and private sector can work together to create significant accomplishments.

Wistar is a research organization that specializes in early-stage discovery science in the areas of cancer, immunology and infectious disease. They conducted their aforementioned work under a Defense Advanced Research Projects Agency (DARPA) and Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) funded program. 

“This development is the culmination of the many steps taken working together with our DARPA/JPEO leadership team and members of the consortium advancing this product at this important time. We look forward to seeing the initial outcome from this first-in-human clinical trial studying this novel concept,” Weiner said in a statement.

This team was awarded $37.6 million to fund the rapid pre-clinical development of DMAbs to prevent COVID-19. For the uninitiated, DMAbs use a person’s own cells as a factory for making the protective antibodies, simplifying the development and the production process for biologics—which could broaden the use of such novel medicines to the global community.

“In addition to assessing safety and tolerability, we will also look for important insights into biological expression and activity in our trial subjects and if these can be shown to impact viral infection,” Weiner stated of the trial.

 spoke to Weiner about the differences in mRNA and DNA technologies, their work on DNA-encoded monoclonal antibodies, and some insights into the clinical trials.



The Wistar Institute’s research on DNA-encoded SARs-CoV-2 monoclonal antibodies (DMAbs) allowed it to advance to clinical trials. One researcher explains how it differs from the mRNA platform.

Looking at the DNA platform: An Alternative to mRNA-Delivered Technologies

This is part 2 of Dr. Chung’s interview. 

Tammy Chung, PhD, a professor of psychiatry and director of the Center for Population Behavioral Health at the Rutgers Institute for Health wanted to determine how the COVID-19 pandemic affected young women’s substance use. In this interview, Chung discusses her methodology and findings.

Chung was unsurprised to find a large number of subgroups within the study population. Some of the young women (about 1 in 5) reported low alcohol, cannabis, and tobacco use before and during the pandemic. Other subgroups reported using just 1 substance, though this was a minority of participants. “The young women who reported 2 or more substances tended to be the majority in this sample,” said Chung.

Significantly, the groups that reported more binge drinking also reported more COVID-19 infections.

Chung had a few theories for why this could be. “It might be that binge drinking increases risk for intoxication,” she explained, “Intoxication, in turn, might make someone less likely to engage in preventive behaviors, like maintaining social distancing or handwashing.”

Binge drinking was correlated with COVID-19 incidence, but the study also examined COVID-19 risk across other types of substance use. Using 2 or more substances, particularly alcohol and cannabis, was the most common, and Chung noted this subgroup could be a target for intervention.

The polysubstance use group was also at higher risk of mental health complications, including depression. This subgroup also reported more income loss and other negative pandemic-related effects.

A majority of the young women that had very low substance use before and during the COVID-19 pandemic were Black. This subgroup showed a resilience to pandemic-related impacts.

Based on these findings, Chung and her team plan to dig deeper into patterns of polysubstance use. “Co-use of these substances are related to increased risk for substance-related problems, and other mental health conditions like depression,” Chung said. “They all travel together in women.”

Young women who binge drink, and especially those who use multiple substances, had a higher risk of COVID-19 infection and mental health complications.

Binge Drinking Increases the Risk of COVID-19 Infection

Did substance use increase during the COVID-19 pandemic? Does increased substance use raise the risk of COVID-19 infection?

, delved into young Black and White women’s substance use during the COVID-19 pandemic.

We discussed the intent behind this research with Tammy Chung, PhD, a professor of psychiatry and director of the Center for Population Behavioral Health at the Rutgers Institute for Health and a corresponding author of the study.

“We’re mainly interested in finding out whether young adult women’s substance use changed from before the pandemic to after the pandemic,” Chung explained. Her team was motivated to conduct this research in response to surveys suggesting substance usage was rising during the COVID-19 pandemic.

This uptick could be due to using substances to cope with pandemic-related stress, Chung said. However, other studies found rates of substance use were decreasing, potentially due to lockdown orders hindering access.

“We were thinking that these national surveys are giving you just averages of what’s happening at the time that it’s going on, and what’s happening at the individual level is really much more interesting,” Chung said. “The population level is glossing over all of these individual differences.”

Chung and her fellow investigators wanted to identify the respective subgroups with increasing and decreasing substance use, which could improve intervention strategies.

Amidst the COVID-19 pandemic altering substance use patterns, women’s substance use has been becoming more socially accepted. Chung added, “I don’t think that there’s been enough of an increased awareness of the associated harms of substance use for women, and that’s what’s important.”

The team pulled data from the Pittsburgh Girls Study for their analysis. The cohort included 938 young adult women, with an average age of 26 years. About half of the sample were Black and half were White.

From this longitudinal community sample, they collected reported cigarette/e-cigarette use, cannabis use, and binge drinking (≥ 4 drinks per occasion).

After identifying these subgroups, the investigators looked for characteristics like race, reported COVID-19 infection, and COVID-related life impacts (i.e., mental health decline, loss of job) that could have affected substance use.

This is part 1 of Dr. Chung’s interview. 

, in which Chung expounds her results and discusses the correlation between substance use and COVID-19 infection.

Studies suggest young women’s substance use is catching up to men's. Tammy Chung, PhD, examined whether this was exacerbated by the COVID-19 pandemic. 

Did the COVID-19 Pandemic Affect Young Women’s Substance Use? Part 1


Hospitalized patients are a vulnerable group that are exposed to pathogens that can lead to healthcare associated infections (HAIs). Of course, now there is the serious concern of these patients getting exposed to COVID-19.

Exposure to COVID-19 has been impossible to contain, and in such cases, having a therapy to minimize severity is important.

Existing therapies have had mixed results and in the ones that are performing better, such as Paxlovid, there is a need for people to take the medication sooner, and there is the “rebound” effect where patients test positive several days later after being on the medication.

Treatments to be utilized for patients in post-exposure situations continue to be explored.

One company, Frontier Biotechnologies, a China-based AIDS/HIV therapy manufacturer has developed an inhibitor, FB2001 (Bofutrelvir), a small molecule inhibitor of the main coronavirus protease being studied for use in hospitalized patients and to prevent COVID-19 following exposure.

The company already has an HIV antiviral that was approved by China’s federal regulatory body in 2018.

Frontier has developed two formulations: an intravenous modality and inhalation version.

Frontier performed a phase 1 study for FB2001, and announced its results earlier this year. In it, a total of 120 participants (80 White people in the United States and 40 Chinese people in China) received intravenous infusions of FB2001 at either single doses from 5 mg to 400 mg, or multiple doses of 30 mg to 400 mg daily for 5 days.

The findings from the study were the following:

FB2001 was safe and well tolerated up to 400 mg per day

Without using a pharmacokinetic enhancer, FB2001 exhibited plasma and lung drug concentration above the 

No significant difference was observed between Chinese and American populations.

No serious adverse events or dose-limiting toxicities were reported.

24 grade 1 or 2 adverse events were observed

The company has since started a phase 2/3 study (BRIGHT trial) to enroll about 1200 hospitalized patients in clinical centers globally. "The phase 1 data were really promising," Frontier Biotechnologies Chief Medical Officer Michael Hu, MD, said in a statement. "And we are confident to carry out the pivotal trial to explore the utility of the drug in reducing the time to recovery in hospitalized patients due to COVID-19."

The company expects to have interim data analysis either by the end of this year or early part of 2023. 

Frontier is also exploring the development of an inhaled formulation of FB2001 that could be used outside the hospital and that may increase drug concentrations in the lung.

Frontier Biotechnologies reported data from its phase 1 trial for its investigational therapy, FB2001, for patients exposed to the virus.

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