In 2 previous segments of a recent interview with 

, Chris Beyrer, MD, MPH, a professor of Public Health and Human Rights in the Johns Hopkins Bloomberg School of Public Health, 

, he discussed the history of HIV messaging and goal-setting. To cap the discussion, Beyrer looked to the future: what does HIV research prioritize in the short- and long-term?

To answer that, it’s worthwhile to consider where past work has fallen short.

“I think we have struggled on 2 research fronts,” Beyrer explained. “One is a vaccine, which has eluded us after many, many attempts and trials. And the other is a cure or long-term remission, and that too has proven elusive.”

Beyrer discussed how it’s the “nature of HIV” to be difficult to eradicate: its DNA integration and memory immune function cell-targeting leaves absolutely curative outcomes an unchecked box.

Nonetheless, Beyrer expressed faith in his younger colleagues.

“The next generation of HIV researchers are focused on the cure, and they’re an impressive bunch,” he said. “We have to be optimistic that we will eventually crack the problems in HIV science, but in the meantime, we could do a lot better on the basics with the tools we have. We could really get control of this epidemic if we did better with health equity.”

It doesn’t hurt to have what he called “robust HIV leadership” at the highest federal levels—including a new US Centers for Disease Control and Prevention (CDC) director who authored one of his team’s epidemiology articles.

“Rochelle Walensky (MD) is not just a terrific physician, researcher, and HIV expert—but she’s also an outstanding communicator, and that’s going to be very, very important,” Beyrer said.

Videos

A talk on optimistic, but pragmatic hopes for HIV cure and vaccine research, led by federal-level experts.

The Future Fight of HIV

As the epidemiology and geographical burdens of 

 have shifted in its fourth decade, the goals and strategies in place to combat the virus among the youngest populations must reflect the changes.

In the second segment of an interview with 

, Chris Beyrer, MD, MPH, a professor of Public Health and Human Rights in the Johns Hopkins Bloomberg School of Public Health, discussed how HIV advocacy has transitioned from an extraordinary grassroots fundraising movement against “anemic funding,” to a push for costly treatment access in burdened regions and countries, and now to a place where its political and media standing is lessened.

“Where we are now is that HIV/AIDS has dropped off the US conversation,” Beyrer said. “But the epidemic has not gone away. It’s gotten worse in fact. It’s become an endemic infection among people in the South and Southeast.”

Along with sharing perspective on shifting messaging and education to meet younger at-risk population online, Beyrer discussed the goal of “closing the gap” on uninsured and underinsured access to means of pre-exposure prophylaxis (PrEP), HIV screening, and testing.

“The uptake remains low, and access remains a problem,” Beyrer said.

Attention to the endemic virus has lessened over years, and screening and prevention access remains limited among the most at-risk groups.

Chris Beyrer, MD, MPH: Evolving HIV Movements

A new series of research articles and insights from nationally-leading 

 investigators highlight the gross and evolving disparities of the endemic virus in the United States.

 last week, the half-dozen features highlight a continued failure by the US to reach HIV’s most at-need prevention and treatment populations, as well as a migration of the majority virus cases from urban coastal regions, to the rural south, where state-level treatment access and prevention messaging is still greatly lagging.

The pieces also highlight the burden continually faced by racial, sexual, and gender minorities with HIV, and such correlations with the ongoing COVID-19 pandemic.

, feature series lead author Chris Beyrer, MD, MPH, a professor of Public Health and Human Rights in the Johns Hopkins Bloomberg School of Public Health, discussed the lack of success in HIV mitigation in the US—despite world-leading funding and a bevy of available resources and agents now proven to combat the former epidemic.

As he noted, HIV decline has been estimated at just 2% annually—a minimal result from massive, but disjointed efforts against the virus.

Additionally, Beyrer discussed the growing disproportion of HIV patient demographics, and the virus’ geographical move in the US from bi-coastal regions, to the South.

“When you see the map in the series, it really speaks volumes on where HIV is and where it’s concentrated,” Beyrer said. “It’s actually the same map as the map of syphilis in the United States, it’s the same map as under-insurance. It’s the map of American slavery and Jim Crow, to be perfectly honest, and that’s striking.”

A John Hopkins expert and major study leader details the evolving epidemiology of the virus.

The Current State of HIV in the United States

In just 5 short days last week, a series of news and developments from a half-dozen vaccine producers resulted in a shifting landscape of 

The US is currently reporting steady drops in new daily cases and continued climbs in first vaccinations administered. But information on the distribution, investigation, and utility of the vaccines—especially given newly observed variants—is crucial to keep this progression.

Watch the video above to catch up on all that occurred in the last week of COVD-19 vaccine news and developments, product by product. From phase 3 data, to new federal regulations and updates on variant protection, both marketed and investigative vaccines have moved significantly in a short period of time.

Interested in learning more about a particular vaccine? Let us know below:

A video breakdown of the past week's developments and news in leading vaccine candidates.

COVID-19 Vaccine Updates for February 2021

 in pregnant women is essentially a non-starter—largely due in fault to the fact that clinicians have no observed understanding of how currently regulated mRNA vaccines interact in the key patient group.

The group was largely excluded, or not at all recruited, for assessment in global, real-world trials which eventually generated the first available COVID-19 vaccines. That said, clinical history would indicate a likelihood of safety for expecting mothers and their newborns.

, Eric Forman, MD, of the Columbia University Fertility Center, discussed why mRNA vaccines—limited in assessment among pregnant women—is theorized to be safe for the population.

“In general, we recommend avoiding live, attenuated vaccines, mostly from a theoretical concern due to the immunosuppressed state of pregnant women,” Forman said. “But even there, there are registries of women who inadvertently gotten MMR before realizing they were pregnant, and the safety was very good.”

As Forman noted, the significant transmissibility and effect of COVID-19, along with the makeup of vaccines, would lead to belief that the patient, her fetus and placenta would be safe. But supporting data is still lacking.

As such, Forman suggested pregnant be considered up-front in future COVID-19 vaccine trials.

“I don’t know if you’d have big enough numbers, but it would have been a start,” he said. “The pregnant state is different from the non-pregnant state, and it shouldn’t be excluded from studies.”

Current trial evidence is severely lacking for the at-risk group, but does clinical history suggest safety?

Navigating COVID-19 Vaccines with Pregnant Women

A new study showed vaccine hesitancy may be highly prevalent among patients undergoing fertility treatment.

In data from a survey-based assessment conducted by the Columbia University Fertility Center and published in 

investigators reported that 58% of 284 patients to receive fertility treatment in the last year stated they would either not receive currently available 

Though the rate is fairly similar to the current general population’s feelings on COVID-19 vaccines, perception was far worse among those further along the fertility care process.

Just 17.3% of patients who were either pregnant or planning to conceive within the next month said they would get the vaccine. Another 90% of patients on fertility treatment said they would not change their treatment plan due vaccination.

, study coauthor Eric Forman, MD, discussed the survey’s findings, and helped to rationalize the concerns of his patients—particularly those already pregnant.

“Pregnant women were not included in the trials to develop vaccines,” Forman said. “We don’t have a lot of data. We know a lot of vaccines are not safe in pregnancy, and are not recommended in pregnancy.”

Adversely, Forman also noted the risk pregnant women may face in viral infection, given they’re considered immunosuppressed. Though understanding of how COVID-19 affects pregnant women is still not perfected, the lack of representation in vaccine trials negates rationale for vaccination.

“We have a high-risk population and they know less than the general population about safety,” he explained.

Forman also touched on other elements influencing fertility and pregnant patients’ current vaccine concerns, including unfounded social media rumors, and the unknowns of messenger RNA (mRNA) vaccines.

An interview on new survey data suggesting a majority of fertility and pregnant patients are not interested in the currently available vaccines.

Fertility Patients Express Concern Over COVID-19 Vaccines

Though this is a matter that—as explained to 

by Adam S. Lauring, MD, PhD—was anticipated with an uncontrolled pandemic virus, it is still going to require an improvement in monitoring and prevention measures immediately.

, Lauring, a professor in the Division of Infectious Diseases at the University of Michigan, and author of a recently published 

viewpoint on genetic SARS-CoV-2 variants, discussed the need for vital means of surveillance right now: SARS-CoV-2 testing, sequencing, and contact tracing.

“They’re somewhat unglamorous but that’s really the key to control,” he said. “Until we have vaccines in the arms of a large percentage of our population, these are the tools we’re going to need to deploy better.”

Lauring highlighted his team’s current work in improved sequence-based surveillance, a strategy which he hopes allows them to more efficiently target control measures, including contact tracing, depending on the variant spread.

He stressed that, though the newest variants do not appear to be more lethal, their greater susceptibility of spread may mean increased cases—and, as such, more critical and fatal cases.

The ability to mitigate or prevent emerging variant spread may also influence the possibility of the virus becoming a constant or seasonal threat.

“It’s certainly possible that this could just become one of the viruses people get sick with every year,” Lauring said. “Nut the hope is we have the vaccines, and we get enough immunity out there that it hasn’t been as bad as it’s been in the last year.”

The ability to monitor, mitigate, and prevent new variant spread could influence the odds of majority immunity.

How COVID-19 Variants Could Change Timelines

 cases continue to rise in early 2021, discussion around the pandemic virus has shifted to the emergence and tracking of differing variants, borne out of mutation.

The most significant of recently observed variants—the so-called B.1.1.7. variant, initially traced from southeast England—has spread internationally at a rapid pace. It is anticipated by experts that it is a much more transmissible form of the virus, and could eventually become the dominant variant in the world.

Though this news come as an alarm—and puts even greater stress on the rollout of available vaccine doses in the coming weeks—it’s nothing surprising to investigators.

Adam S. Lauring, MD, PhD, a professor in the Division of Infectious Diseases at the University of Michigan, and author of a recently published 

viewpoint on genetic SARS-CoV-2 variants, explained the newly discussed variants have been long-developing and essentially inevitable.

“We may see another variant become the dominant strain,” he said. “That’s a lot of what virus evolution is. It’s just something that we’re going to keep seeing, and the work for scientists is to figure which ones are concerning and why.”

Lauring also highlighted the B.1.1.7. variant, a result of numerous mutations which has allowed for greater transmissibility and the potential for the variant to become globally dominant.

Among the practices necessary to address the new COVID-19 threats are increased sequencing and an improvement of social distance strategies.

“It’s important to put the concern in the right place,” Lauring explained. “The more immediate concern is: if this virus is spreading more rapidly, then it’s going to be harder to control period, with our current practices.”

More transmissible variants are emerging quickly. An expert explains why it's expected, but concerning.

New COVID-19 Variants: What Do They Mean?

Acute respiratory distress syndrome (ARDS) can be brought on by COVID-19 and without any approved medication to treat it, patients can be put on a ventilator.

Cleveland, Ohio-based Athersys has developed its MultiStem cell therapy and is studying it for COVID-19 related ARDS. MultiStem is a regenerative candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage.

The therapy was recently given a Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration (FDA) for ARDS. This allows sponsors to work closely with the FDA and receive their guidance on expediting development of their products.

Prior to this designation, Athersys had completed research exploring MultiStem for the treatment of pulmonary distress and recently completed an exploratory Phase 1/2 clinical trial for the treatment of ARDS.

They reported encouraging data from the study, and decided to also explore treatment for COVID-19.

As such, the company has initiated a phase 2/3 clinical trial evaluating MultiStem for the treatment of COVID-19 induced ARDS, which is now enrolling patients. The primary efficacy endpoint for the randomized, double-blind, placebo-controlled study will compare the number of ventilator-free days through day 28 among MultiStem and placebo treatment groups. 


Secondary objectives of the study are to evaluate 60-day all-cause mortality, time in the intensive care unit, pulmonary function, tolerability, and quality of life among survivors through one-year of follow-up. 

Athersys CEO Gil Van Bokkelen, PhD, and CFO Ivor Macleod, MBA, CPA about the investigative therapy and the company.

Athersys has developed its MultiStem cell therapy for COVID-19 Acute respiratory distress syndrome (ARDS). Athersys CEO Gil Van Bokkelen, PhD, and CFO Ivor Macleod, recently spoke to Contagion providing background on the company and their MultiStem therapy.

Stem Cell Therapy for ARDS

An optimist may look at the difficulties surrounding vaccine hesitancy in the US and consider that, given the public’s investment of time and research into understanding 

, the eventual vaccine for the pandemic may be met with more acceptance than previous prophylaxes.

The outcome is a not certain one, but is one that clinicians like Bridget Calhoun, DrPH, MMS, would obviously hope for.

In the final segment of an interview with 

, Calhoun, Associate Dean for Academic Affairs and Research, and Chair and Associate Professor at Rangos School of Health Sciences at Duquesne University, discussed the need for people to learn parameters of vaccine development to better embrace the products.

She discussed how she and her peers are at benefit of being able to trust the development system implicitly, having seen the science that drives vaccines, knowing the oversight that’s required of any regulated product, and participating in the very clinical scrutinization of vaccines.

Calhoun also discussed the likelihood of COVID-19 vaccine risk-stratified prioritization, a strategy which will likely upset those who are not at significant risk of COVID-19 severity nor mortality, but would nonetheless want a vaccination as soon as possible. She noted how a similar situation during a flu vaccine shortage a decade ago led to such criticism.

Regardless of vaccination status in 2021 and beyond, people will still have a role of community protection to play for those at risk.

“There are some people who just can’t get the vaccine, whether they have had adverse reactions to vaccines in the past, or they have demonstrated an allergy to one of the components of the vaccine,” Calhoun said. “We have to be mindful of those folks, too.”

In consideration of the idea that the pandemic may lead to greater knowledge and adoption of preventive health measures.