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Peers and Perspectives

1rem

Yesterday, the Advisory Committee on Immunization Practices (ACIP) granted preferential recommendation for differentiated 

This preferential recommendation includes 

’s Fluzone High-Dose Quadrivalent flu vaccine. Fluzone High-Dose is the only vaccine approved by the US Food and Drug Administration (FDA) for superior flu protection in adults 65 and older.

“This recommendation affirms that all flu vaccines are not created equal, and that this vulnerable population requires better protection that a standard dose vaccine may not provide,” Sanofi said in a statement.

 interviewed Christopher Rizzo, MD, Sanofi’s senior medical director, on why there is a need for a high-dose flu vaccine for seniors, and what it means Fluzone to receive ACIP’s preferential recommendation.

Listen to the mini podcast now to hear Dr. Rizzo’s insights.

As we age, our bodies mount less of an antibody response to vaccination. Rizzo explains that Fluzone High-Dose is a flu vaccine designed specifically for adults 65 years and older, to ensure they generate adequate antibodies.

This is vital, as seniors are prone to severe influenza disease outcomes, such as pneumonia, serious heart conditions, hospitalization, and death.

Fluzone High-Dose has an antigen content 4 times higher than standard flu vaccines. It was proven superior to standard dose in a randomized clinical trial, with Fluzone High-Dose reducing the risk of influenza by 24%.

“It is the only influenza vaccine approved in the US that has superiority to standard dose for those over 65,” Rizzo said.

Listen to our interview with Sanofi vaccine expert Dr. Christopher Rizzo about what this preferential recommendation means, and why high-dose flu vaccines are needed for older adults.

ACIP Preferentially Recommends Fluzone High-Dose Influenza Vaccine for Seniors

, 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

Last Friday, the US Food and Drug Administration (FDA) hosted a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to discuss 

 research, development, and eventual licensing with the Center for Biologics Evaluation and Research (CBER).

Though the live-broadcast meeting did not weigh any regulation decision nor tailor its agenda to any single vaccine candidate or company, it provided the public a glimpse into the mindset of the FDA’s key experts weeks prior to anticipated Emergency Use Authorization (EUA) applications for COVID-19 vaccines.

The advisory committee meeting also allowed for community-based input—of which there was plenty, as advocacy and health organizations alike represented differing patient populations, issues in disparity, and calls for scrutinous, transparent regulation of any possible vaccines.

In this week’s episode of Vaccine Race, Donald Alcendor, PhD, rejoined the limited series to give real-time takeaways from the VRBPAC meeting and what discussion could implicate for COVID-19 vaccine regulation. Among topics, the expert from Maharry Medical College and Vanderbilt University School of Medicine provided perspective on secondary phase 3 assessment endpoints, mandated vaccination groups, pediatric treatment arms, and advocacy representation at the meeting.

for the treatment of adult and children hospitalized with COVID-19 breaking a day prior, Alcendor also discussed what the decision could mean for eventual vaccine authorization.

A glimpse into FDA advisor perspective just weeks before EUAs are anticipated to be sent.

COVID-19 Vaccine Race: FDA Advisory Committee Meeting with Donald Alcendor, PhD

, 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

Few medical advances have progressed with such expediency, scrutiny, and financial backing as the development of 

In just 10 months, drug developers, legislators, and researchers have collaborated on the condensed creation, assessment, and planned distribution of nearly a dozen likely candidates designed to curb coronavirus’ spread. If majority population immunity is the safest, most efficient mean to end the effect of a pandemic that’s already cost 210,000-plus lives, then whatever vaccines reach market could be world-changing.

Beyond coverage of the spread, prevention, and treatment of coronavirus, 

 recognizes the need to give unique focus to this unparalleled clinical effort. Readers can follow along vaccine research and insights on the COVID-19 Vaccine page, and can catch up on the individual candidates’ progression on the 

And now, they can tune in to the Vaccine Race podcast, a limited series designed to provide everything new to know and learn about the COVID-19 vaccine candidates.

The inaugural episode’s featured guest is Donald J. Alcendor, PhD, Assistant Professor of Cancer Biology at Meharry Medical College and Adjunct Associate Professor of Cancer Biology at Vanderbilt University School of Medicine.

After updates on vaccine developments, new data, FDA guidance, and distribution deals, Alcendor joins to discuss the need for vaccine buy-in from hard-to-reach populations and communities historically at odds with healthcare.

Register for the Contagion daily newsletter to receive COVID-19 updates, research, and perspectives straight to your inbox

The Meharry and Vanderbilt-based expert shares insights into reaching less trustful populations on the first podcast episode.

COVID-19 Vaccine Race: Donald Alcendor, PhD, on Community Buy-In

Interview transcript (modified slightly for readability):

a podcast dedicated to bringing you expert insights on trending infectious disease topics. In this episode, we take a dual look at the past, present and future of Ebola.

First, we'll speak to John Johnson, project lead for Ebola vaccination with 

France. We’ll discuss how the ongoing effort in the Democratic Republic of the Congo compares with the response to the West African epidemic, the role of vaccination in the outbreak control strategy, and the unique challenges the ongoing epidemic has presented.

Then, we'll speak to microbiologist Jason Kindrachuk, PhD, about his experiences on the ground in Liberia during the West African epidemic. Kindrachuk is also an expert on current research pertaining to lasting effects in Ebola survivors, so we'll also speak to him for a clinical perspective on what the future holds for those who survive the disease.

My name is John Johnson. I'm project lead for Ebola vaccination with MSF, France. I've been working with them for the last 8 years in different places around the world. Over the last year, I've spent most of my time working in North Kivu on the outbreak of Ebola. Since the outbreak started, I've been here basically in 3 different positions. I started out early on as a project coordinator for infection prevention and control activity. At the time, we were working in Beni, which is a city in North Kivu. That was, at the moment, the epicenter of the outbreak.

I came back a few months later as emergency coordinator and that was more of a role that was based in Goma, the capital of North Kivu, and I was working more on sort of the Ebola response in general for MSF. At the time, we were running several different projects, and our role was anywhere from general non-Ebola support in health centers to managing Ebola treatment facilities.

Since September I've been working on a project to put in place a study for one of the Ebola vaccines, the Ad26.ZEBOV regimen that's produced by Johnson and Johnson. They've been working very closely with MSF, the Ebola response, as well as partners in a consortium to put the study in place.

Thank you for that background. You mentioned the role you have in vaccination efforts and the availability of vaccines is one of the many differences between the outbreak of Ebola few years ago in West Africa and the outbreak we're seeing today in the Democratic Republic of the Congo. Overall, how do you compare these different outbreaks?

 Nothing compares to the West African outbreak in terms of scope. You know, it was it was an extremely large outbreak that was in several countries at the same time.

This outbreak in North Kivu and Ituri has unfortunately become the world's second largest outbreak after West Africa. But it's still one-tenth of the number of cases that we saw in West Africa.

But if West Africa taught us anything, it's that we weren't prepared for a large Ebola outbreak. We didn't have effective treatment. We didn't have effective prevention.

What we really were forced to rely on, back at that time, were public health interventions of isolation, surveillance, and trying to improve case detection to remove [patients] from the population so that they didn’t infect more people.

And then once they were in the treatment centers, we didn't have many options. We didn't have effective Ebola treatments at the time, all we had was supportive care. [The way] Ebola attacks a person, it basically resembles a viral sepsis. You can treat a patient like you would in an intensive care unit with rehydration, other supportive measures like making sure they're well rested and fed, but you don't have much else to treat them with. Since that time, we've been able to develop more experimental therapies.

We've been able to have the preliminary results of a randomized clinical trial published in the 

showing that we have 2 pretty promising candidates for treatment. Those are mAb114 and regeneron, which have given early results showing a reduction in mortality. But the thing that that clinical trial really showed us, among other things, was that the longer a patient waits before coming into receive treatment, the higher the risk for mortality. What we saw in that study was for every day a patient waited before coming to receive treatment there was an 11% increase in mortality. So still, the best option is to come in for treatment early.

The other one of the other big differences between 2014-15 West Africa and this outbreak is that we now have vaccine options, and the one that's been deployed most widely in this outbreak is the rVSV vaccine that was trialed back in Guinea at the end of the 2015 outbreak and was used earlier in 2018, in equatorial Congo during that outbreak.

What role has vaccination had in this in this response? And why was the additional Johnson and Johnson vaccine brought in? Has it been helpful to have that additional tool in the arsenal, those sorts of things?

The rVSV vaccine is really a game changer. We see that it's an effective vaccine. After the West African outbreak this was the vaccine that was the most advanced and the most studied. There was a global stockpile created of about 300,000 doses.

When we started using the Merck vaccine it was 300,000 doses, that's a lot for an Ebola outbreak. Most Ebola outbreaks are less than 100 patients. You wouldn't need a large stockpile. And nobody really expected another large Ebola outbreak anytime soon.

When we started vaccinating right away in August of 2018, things were going fine until we started really worrying about if we would run out of Merck vaccines. It was at this point that people started looking for plan B.

But just to give you a bit of background on the role that vaccines played, the strategy that was used for the deployment of Merck was what they call a ring strategy. The ring strategy is nothing new. It's what was used to eradicate smallpox. To very briefly explain the ring strategy, what you do is you take your index case, you vaccinate their contacts—so anyone that they've come in contact with the past few days&mdash;and then you go to those contacts, and you make a list of the people they've been in contact with over the past few days, and you vaccinate their contacts. So it's called the ring strategy because it's a ring around the patient, and then a second ring around the contacts.

The people that have already been exposed to Ebola, may or may not have already

developed the virus in their body and we may be vaccinating someone who already has Ebola but hasn't exhibited symptoms. The protection really starts at the second ring, the second line of contacts of contacts. But what we saw with a Merck vaccine was that there was also some protection offered to people even if they'd already been exposed to Ebola. It did reduce the risk of mortality.

We were using the ring strategy with [the Merck vaccine]. But the problem with the ring strategy, well, there's no problem with a ring strategy. Theoretically, it's quite sound. The problem was always with the implementation of it. In the context of North Kivu where there's a mobile population, and people that are already somewhat resistant to the Ebola response, we never were able to vaccinate enough people because we were never able to identify and follow all of the contacts.

The interest in having a second vaccine, for example, the J&J

[Johnson and Johnson] vaccine has a global stockpile of 1.5 million doses. And with that vaccine, we could do a complimentary strategy, where contacts and contacts and contacts get the Merck vaccine, which is now proven to be very effective, and the J&J Vaccine could be used for a larger percentage of the population living in those areas that are affected but have not come into direct contact. That would therefore be a preventive strategy for these populations at risk.

You mentioned some of the community resistance to the response, right? The outbreak response area has several armed groups operating within it, there's a conflict which ultimately dates back to the 1990s, and that rightly gets attention. But outside these groups in everyday Congolese society, it seems there's a degree of skepticism when it comes to the national and international response as well.

 Congolese people are just like people everywhere. They want to go see their family doctor. They want to be treated by people that speak their language and that understand them and that they know. Instead of being treated by their family doctor, they were sent through a sort of grinder of the Ebola response.

A lot of the things that we heard were that you guys aren't here because we're sick. You're here because we're contagious. We've been sick for years, we've had cholera, we've had malaria, we've had malnutrition, we've had armed groups attacking us, and nobody came. And all of a sudden, there's a disease that scares you. And you come with a massive response with lots of money. And I think they've got a good point, we really pay so much attention to

threats of global pandemics. And we've not really supported them in the last 20 years when there's been the Kivu conflict, when there's been outbreaks of different other diseases. I think there's something to be said for that line of reasoning.

A simple example is right now in the country you have the world's largest measles outbreak, ever. And it attracts far less attention than the Ebola outbreak and measles has killed 6000 people already, where the Ebola outbreak over the last 18 months has killed 2000. And that's not to diminish what Ebola is or the fear that Ebola causes. But to say that when you're when you're living through it and see children dying of measles, and nobody's really interested, it is hard for them maybe to understand why.

That's a thoughtful response. I appreciate that.

Is there anything else infectious disease clinicians around the world should know about Ebola as a virus, about the Ebola outbreak response, to better understand what's going on in this international effort?

We really don't know much. Still, we really don't have a lot of information about this disease. We really are trying to understand it and trying to learn. I think it's important to be able to do research and to study and to pay attention when we do have these Ebola outbreaks so that we can better respond next time and try to gain as much experience as we can

And I think I think things like the randomized clinical trial that was carried out, the study with the Merck vaccine and the study that's going on with the J&J vaccine, really will help us in the next outbreak. We need to be prepared for the next outbreak to study something new that can help us prepare for the next one. Ebola is always going to be one step ahead of us and we need to prepare for that.

Now we're speaking with Jason Kindrachuk, PhD, Assistant Professor of viral pathogenesis in the Department of Medical Microbiology at the University of Manitoba. Let's start with your involvement in the West Africa Ebola epidemic.

Where I got involved in outbreak response was really when we saw Ebola hit West Africa. We saw that the case numbers initially were fairly low. But there was this long steady increase over time. And I think most of us that are within the filovirus field of research were getting the feeling that this was different.

We were starting to see cases that were spreading across Guinea, Sierra Leone and Liberia. And we were starting to see cases that were going into the heavy populated regions. Once cases got announced in in West Point, which is one of the main slum areas of Monrovia, Liberia, we got nervous, we knew something was going awry with this.

Around the same time, Nancy Writebol, and Kent Brantly, who were both physicians with

Samaritan's Purse got infected while serving in West Africa, and they were brought back to Emory in Atlanta. There was suddenly a surge in the media representation of healthcare workers getting infected in West Africa, media coverage increased, and there was suddenly a pressure to get an international response effort together.

The NIH and the US Centers for Disease Control looked for volunteers that had high containment experience, research experience within the biosafety level 4 laboratory and had a comfortability with the idea of going out and working in the field.

The initial call came mid to late July 2014. I volunteered the first week of August, and was on a plane by the first week of September. I landed in Monrovia not long after one of the protest groups was actually digging up bodies and putting them onto the highways because they didn't feel that the virus was real, or that the outbreak was real.

I went over as a scientific lead for one of the diagnostic laboratories that was serving all of Liberia. Our laboratory, which was at the Liberian Institute for Biomedical Research, we were getting samples from across all Liberia, so not only hospitals or Ebola treatment centers in Monrovia, but across the entire country.

On average, we were getting you're probably around 70 samples a day. I think we ultimately processed 1600 samples over four weeks.

There were three of us that came from the US, including myself, and we had 4 or 5 Liberian researchers that were volunteering their time with us who'd worked in malaria diagnostics.

We had a makeshift containment lab, which is it was not a BSL-4 [Biosafety Level 4] lab, but we were in respirators and protective suits, with no air conditioning, and we processed blood in whatever samples we received all day and all night for , seven days a week.

Did you get much interaction with any patients, or was it mostly in the lab there?

In this episode, our guests compare the West African Ebola outbreak to the ongoing outbreak in the Democratic Republic of the Congo.

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