Kevin Kunzmann

 When will pediatric patients be assessed?


 The inflection point of vaccine development


What is the trial participation commitment?


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.

Podcasts

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

Research from a pediatric emergency department (ED) setting showed a 12 percentage-point increase in 

 among children who tested negative for a virus on a rapid respiratory pathogen (RRP) test.

 by Suchitra Rao, MBBS, MSCS, Associate Professor of the University of Colorado School of Medicine, supported a paradoxical finding that antibiotic prescribing is more likely in instances when RRP tests are administered, regardless of their results.

Now, Rao and colleagues are looking for means to explore better use and presence of antimicrobial stewardship in pediatric emergent settings. One idea, Rao told 

 during IDWeek, is the implementation of more stewardship educational materials, and guidances based on the general decision-making strategies of different care teams.

Rao also expressed interest in observing the same comparison—antibiotic prescribing in children given or not given RRP tests—with the addition of stewardship teams, as well as in instances when even faster test results are available.

“The good news is some of these newer molecule panels have excellent sensitivity and specificity,” she said. “So if the collection method is done in a reasonable way, then you can really rely on and trust that test.”

Rao also touched on the need limit antibiotic prescribing in patient populations—particularly compared with more at-risk populations.

“I think that the general thought when you’re dealing with someone over 65 with a lot of different medical comorbidities is that the risk of missing a bacterial infection has a huge impact,” Rao said. “And there’s often a trigger to pull on antibiotics in that group, and rightly so.”

In pediatrics, she noted, risk factors are different, and clinicians often have more time to make prescribing decisions. It actually may be more prudent in such cases when symptoms are not severe and the clinical setting is not acute, to assume a viral cause in a child, and make prescribing decisions based on test results.

Watch the full interview with Rao in the video above.

Videos

Why it may be more prudent for prescribing clinicians to assume viral, rather than bacterial, infection while awaiting test results in presenting pediatric cases.

Suchitra Rao, MBBS, MSCS: Antibiotic Prescribing in Children

data pooled from the CONSTANT and PROTECT

 phase 3 trials showed tri-antigenic hepatitis B virus (HBV) vaccine (TAV) was faster and more efficacious in establishing anti-HBV titers versus mono-antigenic HBV vaccine (MAV) across all its observed patient populations.

The data, presented by study author Joanne Langley, MD, Professor of Pediatrics at the Canadian Center for Vaccinology, Dalhousie University, provided greater promise for vaccination options against HBV—a very necessary venture given the field’s current inability to cure HBV index cases with therapy.

“We’re not close to (HBV) eradication,” Langley told 

. “Like hepatitis C, there’s a carrier state for hepatitis B, and we don’t have a therapy where we can eradicate that carrier disease.”

Unfortunately, in regions of the world where chronic carriage of HBV is very prevalent, testing resources and capability lack behind, Langley explained.

“There’s this pool of apparently well people who may not even know they have hepatitis B carriage, and they can transmit to others,” she said. “And we have no way to interrupt that spread other than infection prevention and control.”

That makes these new findings for a promising TAV option all the more important, as the CONSTANT and PROTECT data will be used to support applications for regulatory use in prevention HBV.

However, more research may be warranted. Langley expressed interest in observing TAV’s prophylactic benefit for unique patient populations: immunocompromised patients, those on dialysis, and those with liver disease. She also hoped to gain better understanding of the immune response durability and length.

Watch the full interview with Langley in the video above.

The presenting IDWeek author discusses the implication of promising phase 3 data for a new HBV vaccine.

Joanne Langley, MD: The Need for Hepatitis B Preventive Care

 showed an 85% associated reduction in non-ventilator 

 infections in a medical center through 12 months among patients given oral care from nurses and nursing assistants, versus those provided standard care.

As the most common hospital-acquired infection, NVHAP’s significant reduction among patients given the very rudimentary oral care inspired investigators at the University of Massachusetts Amherst to consider the benefit of oral care as a therapeutic, not comfort, measure. Led by associate professor Karen Giuliano, PhD, they are now pursuing a randomized, controlled trial.

In the second segment of an interview with 

 during IDWeek, Giuliano explained how there may be added benefits for reducing mortality or lengthier hospital stay among patients with viral infection, including coronavirus 2019 (COVID-19).

Recent data from Germany has indicated antiseptic mouthwash could reduce COVID-19 viral load in the mouths of patients—meaning lessened risk of hospital spread.

“In previous viral pandemics, a lot of times you get sick from the virus, but what makes you really sick is the secondary bacterial infections, which is really what we’re talking about with hospital-acquired bacterial pneumonia,” she said.

Giuliano also explained how oral therapeutic care would likely fall to nurses and nursing assistants—a pair of positions already burdened with work in hospital settings.

“There’s not a lot of downsides to keeping a person’s mouth clean,” she said. “What we compete against is nurses, nursing assistants, and frontline clinicians of every kind dealing with tons of competing demands every day—and certainly, that’s worse with COVID.”

Watch the full interview with Giuliano in the video above.

New data may evidence oral care as a therapeutic measure to reduce bacterial and viral spread.

Author | Kevin Kunzmann

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