We cannot assume that information about disease states, viruses, or any other health conditions are passed down from generation to generation and that these things do not need to be discussed anymore.

Much like we saw with the COVID-19 pandemic, several years ago when HIV/AIDS became an emerging health care threat, it was considered a serious virus that often had fatal consequences. It caught people's attention and major awareness campaigns were conducted to educate the public about transmission and prevention.

In the ensuing years, the development of antiretroviral therapy (ART), changed the way society perceives HIV from a virus with deadly consequences to one that potentially can be a chronic condition. ART has been a treatment 

 for PLWH. In trying to prevent HIV, the development 

 has been a wonderful addition to the treatment armamentarium.

And while the addition of these therapies has been transformative, one area seems to be lagging behind: a lack of HIV education to younger generations. And this had led to an uptick in new infections in young people.

According to the US Centers for Disease Control and Prevention (CDC), about 1 in 4 (26%) of all new HIV infections is among youth ages 13 to 24 years. And about 60% of all youth with HIV do not know they are infected, are not getting treated, and can unknowingly pass the virus on to others.

In looking to combat the lack of information getting to young people, advocacy campaigns have been trying to fill this void. Merck, for example, has developed its Owning HIV awareness campaign, which was “created with Prevention Access Campaign and HIV advocates to inspire all of us to own the future of the HIV epidemic.” Merck 

 amongst Millennials and Generation Z’s looking at their knowledge and attitudes towards HIV.

According to Merck, “survey findings uncovered a jarring trend of general confusion and insufficient knowledge about HIV and its transmission among survey respondents, along with the existence of high-risk sexual practices, poor disease management, and stigmatizing behaviors among young adults.”

In lending its support to educate the public, the Prevention Access Campaign developed its Undetectable equals Untransmittable (

) campaign, which aims to have the public understand that for those with undetectable levels of viral load cannot transmit HIV through sex.

spoke to Murray Penner, US executive director at Prevention Access, and he provided further insights into U=U, discussed the Owning HIV Survey results, the importance of PrEP, and the lingering stigma around HIV.

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As younger generations come of age, there is a continuous need to inform them about HIV risks, offer insights about prevention strategies, and understand the challenges for people living with HIV (PLWH). 

Education Remains Significant to Public Understanding About HIV, Prevention

Typically, healthcare workers (HCW) have higher vaccination rates than the general public.

According to the Centers for Disease Control and Prevention (CDC), 80% of healthcare workers reported receiving influenza vaccinations for the 2019-2020 season, and coverage was reported to be similar the year before.

Still some challenges remain to getting more HCW in for their vaccinations. To begin with, the COVID-19 pandemic created another unforeseen barrier last year. 

When asked if her colleagues are getting vaccinated, Lisa C. Bailey, RN, MS, infection control preventionist at the Northport, NY VAMC, says many of them state time constraints and a lack of convenience as reasons for delaying or not getting vaccinated.

In 2019, Bailey and some of her colleagues implemented a fixed external drive thru point of distribution (POD) vaccination drive. They set it up in the parking lot of their center. For 2020, they had COVID-19 protocols to consider. They had 10 tables with 19 nurses administering vaccines. Masking was enforced for employees receiving the vaccine, and the nurses wore face shields to ensure protection. Employees were able to get their vaccines while remaining in their cars. They collected consent/declination forms to track vaccinations.

Bailey and her colleagues recently presented a poster with the data from the vaccine drive at the 

2021 Association for Professionals in Infection Control and Epidemiology conference

They deemed it a success as they saw improvement in the numbers from 2019 to 2020. They were able to administer the flu vaccine to 385 employees over a 90 -minute interval at a rate of 427 doses per 100 minutes in 2020. And this is compared to 290 employees getting vaccinated and 322 doses administered per 100 minutes in 2019.

 spoke to Bailey recently about their vaccination drive-thru, some takeaways for others considering vaccination drives, and what they are planning for this year.

A group of personnel at a veterans administration medical center (VAMC)) did a drive-thru to help bolster vaccination amongst coworkers.  

Making Influenza Vaccinations Convenient for Healthcare Personnel

In May, Ferring Pharmaceuticals presented data at the 2021 Digestive Disease Week (DDW) Virtual Meeting, demonstrating the company’s, investigational therapy, RBX2660—the lead product in their 

—has shown promise as the first microbiota-based live biotherapeutic to show efficacy in the first recurrence of 

Specifically, the data showed that with a single dose, RBX2660 demonstrated superior efficacy vs. placebo (70.4% and 58.1%, respectively) at 8 weeks post-treatment. RBX2660 is the only microbiota-based live biotherapeutic to demonstrate efficacy as early as first recurrence of CDI. The company says the majority of treatment emergent adverse events (TEAEs) for RBX2660 were similar to placebo, and mild to moderate in nature. 

The platform was developed by Rebiotix Inc., a Ferring Company, and RBX2660 is being studied to deliver a broad consortium of diverse microbes to the gut to reduce recurrent 

 infection. The treatment has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the US Food and Drug Administration (FDA).

Ken Blount, chief scientific officer, Rebiotix, and vice president of Microbiome Research, Ferring Pharmaceuticals recently spoke to 

 who provided further insights into RBX2660, takeaways from their studies, and the development of an oral formulation.

The company’s RBX2660, administered as a single dose, demonstrated superiority  over standard of care for reducing Clostridioides difficile infection (CDI) recurrence.

Ferring’s Microbiota Therapy for C Diff Shows Promise 

One of the concerns within medical science is how long protection will last for the existing COVID-19 vaccines. More recently, there have been open discussions about the potential need for booster shots to provide further protection when immunity wanes. 

Up until now, there has not been any technology that can measure immunity responses. 

., just launched its VaxEffect platform. Renold Capocasale, CEO and founder of FlowMetric, and Grant Morgan, PhD, PMP, executive vice president for FlowMetric and general manager of VaxEffect, spoke this week on the platform, its clinical application, and future plans for immune response tests for other vaccines beyond COVID-19.

This is the second installment of the conversation with them. To view the first interview segment, click 

The transcript has been edited for clarity and length.

Q: Could VaxEffect potentially help in identifying a time frame for COVID-19 booster shots?

 One of the aspects of the test that's really important is that we can do repeat testing. This will actually be timed very well with a lot of talking now about getting booster shots, either of the same vaccine you've received previously or potentially a different vaccine to see if that generates an additional immune response. What we think we'll be able to do is track over time the immune response to the vaccine and then provide that additional information to the health care provider as to when might be the right and optimum time to provide that booster to the patient.

Q: If a person registers as a low responder, what does that mean in practice?

It's actually very interesting. For a low responder, there's a level of uncertainty as to whether there is a protective level of immune response against an exposure down the road to the virus. Right now, in the scientific community, we do not know what the correlate of protection is so what is the amount of antibodies you need to generate that protects you from further exposure to the virus? So that is not known yet, but there's a lot of research going on to understand what that correlate of protection is. The antibody test that we have, the VaxEffect immune response test, because it generates a quantitative response, we should be able to, in working with other health care providers, actually correlate the level of protection a person has and whether that should afford them protection to further exposure to the virus.

That’s something we think in the future, as more and more data [are] gathered, we will be able to offer to doctors and their patients as to whether—even if they have a weak immune response—is it sufficient to provide at least some partial protection to future exposure?

Q: Recent studies have sought to examine how immunocompromised patients, including patients with cancer, respond to the vaccine. How could VaxEffect help?

What we're seeing with immunocompromised people, including people who have suffered from various different types of cancer, is that the immune response to the vaccine they receive is very varied. Some patients actually generate strong immune responses and, therefore, could be considered to be protected from the virus in going forward in their everyday lives.

But what they are seeing in both oncology specialties, but also for organ transplantation, diabetes, geriatric specialties, [is] that people have a reduced response to the vaccine they receive. And with regular serology tests not based on our platform of flow cytometry, they are actually getting results that say they are not generating any kind of immune response. But because the flow cytometry platform that we utilize for the VaxEffect test is so sensitive, we are actually able to identify a positive but weak immune response to the vaccine they received, which means there is a potential for a booster shot to actually increase that initial immune response that they generated.

VaxEffect is different to other tests on the market, specifically serology tests, in that a majority of them are over a very small dynamic range, which means that they can only give you really a qualitative result of ‘Yes, you've been infected or vaccinated and created an immune response,’ or ‘No, you haven't.’ The VaxEffect test, built with different technology on flow cytometry, is able to actually detect not only were you infected with the COVID-19 virus or created an immune response to the vaccine, but also the level of immune response that you were able to generate in response to either prior infection or to the vaccine.

 The status of VaxEffect is that we just recently launched, and we are targeting VaxEffect to health care professionals in support of their patient needs addressing basic fundamental questions around how effective was the vaccination that they received against COVID-19. To date, we've tested over 1000 individuals either looking at their response to natural infection or their immune response to whatever vaccination they received for COVID-19.

Q: What is the key takeaway for clinicians?

: We believe the key takeaway for clinicians is an additional test, something that has never been used before or been available before, for doctors to inform their patients as to how well they've responded to the vaccine they received. So not just the simple, yes/no qualitative response to the vaccine we receive, but actually be able to inform their patients that they generated an immune response, which is similar or comparable to what others who have taken the test have generated. The doctor will also be able to offer a service where they can track that immune response over time and, therefore, make informed decisions about whether a patient would need a booster shot or should take extra precautions if their immune response was below what people believe is enough of an immune response for normal return back to everyday life.

 VaxEffect is a platform that will have life beyond just COVID-19 vaccination immune response monitoring. It is a platform that will allow us to use the same technology and science to support basically any vaccine regimen that you receive. We anticipate, later this year, launching VaxEffect specifically for other vaccines such as Gardasil or Shingrix. We are excited at the prospect of patients having a much easier ability to monitor over time their vaccine immune response.

Quite simply, we believe the most important takeaway for clinicians for the VaxEffect platform is the alignment of unmet needs for the patient and their health care provider. We think it's really important for patients who have underlying conditions that may cause them extra risk for actually generating an immune response to have an easy, accessible, and highly communicative approach to their immune response to the vaccine.

For us, COVID-19 has been, obviously, an anxiety producing event for many people. To have a patient who doesn't really know more than yes/no where they stand, immunologically speaking, in response to a vaccination we think is important. It's peace of mind for both the physician and their patient, and it's actionable because we can monitor over time with easy-to-read data that is addressable by the physician to their patient. All of us have elderly parents who have received the vaccine. Wouldn’t it be great if you could show them, in quite easy terms, that they have generated an immune response [and] that they are protected? We all know individuals who are undergoing cancer therapeutic regimens that create immunodeficiency. For them, it's not just yes/no. For them, it's nice to see that they actually have generated some response. It brings hope.

In the second installment of an interview, members of the FlowMetric Life Sciences' leadership discuss how their technology might aid possible COVID-19 vaccine booster shots, how immunocompromised patients respond to vaccines, and other vaccines where their platform may be used. 

Quantifying the Immune Response and Level of Protection for Vaccines

A new vaccination immune response monitoring platform is going beyond a simple “Yes/No” and providing clinicians and patients more quantitative data regarding immune response to COVID-19 vaccination. The test could be especially beneficial for immunocompromised patients by informing timing for boosters down the road.

., just recently launched. Renold Capocasale, CEO and founder of FlowMetric, and Grant Morgan, PhD, PMP, executive vice president for FlowMetric and general manager of VaxEffect, spoke this week on the platform, its clinical application, and future plans for immune response tests for other vaccines beyond COVID-19.

Transcript has been edited for clarity and length.

 FlowMetric Life Sciences was created over a decade ago as a contract research organization (CRO) dedicated to advancing pharmaceutical and biotech drug development initiatives. We specialize in cellular analysis as it relates to interrogating the immune system to address safety, efficacy, and potency of new drugs coming to market. We are divided—or broken up into—2 companies, so our CRO division, which has pharmaceutical and biotech clients, and, more recently, our diagnostic division, which is where we develop LTDs to address various test needs and VaxEffect falls under that division.

Q: What was the inspiration behind VaxEffect?

 VaxEffect as a platform really was inspired quite some time ago when I was a researcher at [Johnson & Johnson] in the lab. My first son was born and, of course, trying to be very responsive for all of the background that I had in immunology was certainly very keen on following his vaccination schedules. I remembered quite distinctly asking pediatricians at every vaccination meeting that we had if it would be okay if I could get titers for my son, and I always posed the question, ‘Well, how do we know actually that he's generated a good immune response?’ And literally, pediatricians kind of chuckled and said to me, ‘Well, we don't really do that.’ So that was the really the genesis of the idea back when I was a bench scientist, and I took that along. When FlowMetric Life Sciences launched its diagnostic division back in 2015, we were certainly motivated to come back to that question. Certainly, at this point, the perfect storm of COVID-19 appearing on the scene made it obvious which vaccination we should begin with in terms of developing specifically a test around looking and measuring that specific immune response to a vaccine. That was the genesis of COVID-19 VaxEffect.

Q: What is the science behind VaxEffect? How does it work?

 The science [is] based on flow cytometry, where we're able to actually detect levels of antibodies specifically in the blood of the patient that provides the sample. It detects a quantitative level of those antibodies, and then provides a very easy-to-understand output report that shows whether you've responded to the vaccine or have been previously exposed to the virus, and also how much of a response you generated as measuring quantitatively the level of antibodies you have in your system.

Unlike other serology tests available today, the VaxEffect test is actually built on multiplex flow cytometry and what that enables us to do is to detect 2 proteins associated with the COVID-19 virus. The first protein is called the nucleocapsid protein and this is actually found hidden inside the virus. You are only exposed to that protein if you've been previously infected by the virus. You'll generate antibodies to that, and that's able to be detected by our tests.

The second protein that the test is able to identify is the RBD protein that's on the spike part of the virus. This is actually what's used in all the vaccines that are given to everybody, and so we are able to uniquely identify over a wide quantitative range the level of antibodies you've generated to that vaccine based on the immune response to the RBD spike protein.

One of the unique things about the VaxEffect vaccine immune response tests is that, unlike other tests, it's actually able to offer 4 unique answers or responses to questions that you may have. The first one is: Did I actually generate an immune response? It's a quantitative assessment, yes/no, to generating immune response to the vaccine you received.

The second one is, because of the uniqueness of the platform we use in flow cytometry, you're able to quantify the amount of vaccine immune response that you've generated over a very wide dynamic range, and this is called the VaxEffect Score. This will not only tell you how well you've generated an immune response, but you will be able to actually see where your immune response level is in comparison to other people who've taken the test.

The third component is that you can actually track over time that immune response. We envision [a scenario] where a patient would have a VaxEffect test to see what their immune response was like to the vaccine they received, and then have repeat tests every 3 months [or] 6 months to see whether they are maintaining that specific immune response to the vaccine they received.

The last component of this is whether you have a prior exposure to the virus. Forty percent of people who were exposed to the virus did not know they had generated or been exposed to the virus, and therefore generate an immune response. We're able to actually uniquely identify those individuals who have been exposed to the virus. With this test what we think we have is something where you can uniquely quantify and track your immune response to the vaccine you received or to the COVID-19 virus that you were previously exposed to.

 We believe the primary user for the VaxEffect immune response test actually will be the physician's office. We believe that doctors will be really interested in utilizing the test to really understand their patient's immune response to the vaccine or if they've been previously exposed to the virus. What we've heard is that, especially in immunocompromised patients, doctors are unable to provide a real definitive answer as to whether the patient [has] actually created immune response to the vaccines they've received. This is tremendously important when patients are thinking about returning to their everyday lives, returning to interacting with their families, going on vacation.

For most of us, we don't even think about it now. We think we've been vaccinated, and we just assume we’ve had a good immune response. For immunocompromised patients, it's a different story. They really don't know if they've created that robust immune response, and the doctors are unable to provide the information. We think this test, for a healthcare provider, will be able to turn to that patient and say, ‘You know what, I can actually now give you a simple blood test and I can tell you the response you've made.’ And because it's extremely quantitative over a very wide dynamic range, that doctor will be able to say to the patient whether they've even generated a weak immune response, which may indicate that they could potentially get a booster shot, which would increase their antibody levels, and then make them feel more comfortable about returning to the world and environment than they used to.

Articles

FlowMetric, Inc., discusses its VaxEffect, an immune monitoring platform and how it can be used to measure COVID-19 vaccine responses.

VaxEffect Test Allows Clinicians to Measure and Track Immune Response to COVID-19 Vaccination 

This week, the Association for Professionals in Infection Control and Epidemiology (APIC) held their annual conference virtually from Sunday through Wednesday.

The conference saw many important issues discussed and research presented, dealing with antibiotic stewardship, prevention, emerging infection surveillance and other critical topics in the fields of infection control and epidemiology.

To gain a broader understanding of the association as a whole, 

 sat down with Devin Jopp, EdD, MS, who is the CEO of APIC.

In the interview, we discussed the basic mission of APIC, the role they played during the 

 pandemic, how the conference is important in the current climate, what the association adds to the field of infection control and what the future looks like.

To view more of our coverage from APIC 2021, click 

A discussion about the Association for Professionals in Infection Control and Epidemiology with CEO Devin Jopp.

APIC and the Importance of Infection Prevention

Now that Seqirus and Novavax have set a benchmark for assessment into 

 vaccine co-administration, it’s time to explore greater outcomes.

In the final segment of an interview with 

, study co-author Dr. Raja Rajaram, Medical Affairs Lead for EMEA at Seqirus, discussed the next steps of assessment between the collaborative vaccine developers, as they pursue precedence—and possibly, regulation—for COVID-19 and flu vaccine co-administration prior to the 2021-22 flu season.

 of recombinant protein COVID-19 vaccine candidate NVX-CoV2373 and 2 of Seqirus’ seasonal flu vaccines had preserved immune efficacy in administered volunteers versus placebo—without observed new safety concerns—Rajaram and colleagues are seeking outcomes in co-administration of their flu vaccines with mRNA COVID-19 vaccines.

That ongoing trial is taking place in the UK, and may have vast implications for the US population which has been predominately vaccinated against COVID-19 with Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273.

Rajaram and colleagues are pursuing essentially similar endpoints across different COVID-19 vaccine types, he explained, with the priority being on adverse events.

“Reactogenicity is the key endpoint they’re looking for, and then they’re also going to be pursuing the immunogenicity of flu and COVID-19, of course,” he said.

Seqirus is seeking reactogenicity and immunogenicity outcomes between its influenza vaccines and available mRNA vaccines for COVID-19.

Can mRNA COVID-19 Vaccines Be Co-Administered with Flu Shots?

Though Novavax and Seqirus are the first collaborative 

 vaccine developers, respectively, to present 

 of co-administration in volunteers, there is anticipation this may become a standard practice in the coming fall and winter seasons.

What exactly COVID-19 and flu vaccine co-administration may look like is not yet well-defined, but experts anticipate it could be a win-win practice.

In the next segment of an interview with 

, Dr. Raja Rajaram, Medical Affairs Lead of EMEA at Seqirus, discussed how the trend of flu vaccination as a “behavioral norm” may help improve global COVID-19 immunization efforts.

“Some of the population may be going forward for their flu vaccines, and that is an opportunity to find out if they’ve had their COVID-19 vaccines,” he explained. At the same time, COVID-19 vaccine appointments may be an ideal opportunity to initiate flu vaccination behaviors in patients as well.

Rajaram also discussed the rapidly-expanding respiratory virus assay market, and how the switch from defining flu by test results rather than diagnostic code may help public health awareness efforts.

“What I do hope for after COVID-19 is that (the testing market) expands to include flu and other respiratory viruses, because it will help the public understand what is the disease burden every winter,” he said.

Plus: how could the COVID-19 testing market boom improve public flu awareness?

The Benefit of COVID-19 & Flu Vaccine Co-Administration

To-be-published clinical data from Novavax and Seqirus show the former’s COVID-19 vaccine remains efficacious and safe when co-administered with the latter’s influenza vaccines.

The findings, currently in pre-print status, are the first step toward assessment of coinciding vaccination among persons who may be at increased risk of circulating SARS-CoV-2 variant infection—as well as the flu—in the upcoming fall and winter season.

The threat of simultaneous respiratory viral outbreaks was averted last flu season, despite expressed concern from infectious disease experts, due to social distancing and masking mandates put in place during a resurgent third wave of COVID-19. But this upcoming year presents another opportunity for a pandemic-epidemic overlap.

In the second segment of an interview with 

, study author Dr. Raja Rajaran, Medical Affairs Led of EMEA at Seqirus, discussed the need for clinical and public health preparedness against a winter flu surge.

“The problem is we’ll never know until the surge, so people are starting to recognize from a public health standpoint that we should be prepared, and we should continue the vaccination updates,” he explained.

Rajaran also discussed the fascinating, nearly-identical crossover of standard COVID-19 and flu risk populations—which certainly helps to simplify vaccination target groups for the upcoming flu season. He added though, the effects of COVID-19 and flu in children is significant, and requires its own attention in preventive measures.

COVID-19 response restrained flu outbreaks last year. An expert explains his concern that won't be enough this winter.

What Will the 2021-22 Flu Season Look Like?

Preprint data has been published from the first phase 3 trial to demonstrate efficacy, safety, and immunogenicity of a 

The findings from a collaborative sub-study assessment between Novavax and Seqirus show the former’s recombinant protein COVID-19 vaccine candidate NVX-CoV2373 and 2 of the latter’s seasonal flu vaccines had preserved immune efficacy in administered volunteers versus placebo, without observed new safety concerns and adverse events similar to those associated with each individual vaccine.

The trial included 431 volunteers from the UK being randomized 1:1 to either investigative NVX-CoV2372 plus adjuvanted trivalent or cell-based quadrivalent flu vaccine, or placebo.

regarding the findings, study co-author Raja Rajaran, Medical Affairs Led of EMEA at Seqirus, highlighted the impact of a COVID-19 and flu vaccine co-administration going into the 2021-22 flu season.

As Rajaran noted, experts and peers have begun speaking confidently to the conception that COVID-19 will remain active in the global population for “at least a few years,” due to circulating variants.

“Would we call that seasonal endemic, or what we would call what will happen in the next few years is a matter of debate,” Rajaran said. “I don’t think there’s a straightforward answer, but we will have COVID-19 circulating for the next few years, and one of the concerns is that when you open the travel up and reduce the social distancing measures, then flu can also emerge.”

Rajaran also discuss how the global population’s lack of exposure to overall viruses has created a “danger” to flu exposure and severity going forward.

An interview with a study author on new Novavax-Seqirus co-administration trial data, and the future concerns of circulating COIVD-19 and influenza.