Findings increasingly suggest the mortality risk may be reduced by initiating daptomycin within 3 days of infection.

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A review of selected investigational long-active treatment options for HIV.

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Kevin J. Downes, MD, and Contagion® Section Editor Conan MacDougall, PharmD, MAS, BCPS, BCIDP, discuss these important topics as another season approaches.

Children, COVID-19, and Another Crazy Respiratory Viral Season

"Humans dislike change, especially when it is rapid, unexpected, or negative. Delta is all 3."

Delta Means Change

As the number of etiologies increases, we must ground our application of new diagnostic modalities with appropriate assessments.

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The evolution of the major variants, including the delta mutation.

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. Prior to joining MJH Life Sciences in 2020, he has covered a variety of fields and markets including diabetes, oncology, ophthalmology, IT, travel, and local news. You can email him at 

After a day of presenting booster dose data, feedback and deliberating on the efficacy of the Pfizer-BioNTech COVID-19 vaccine, the VRBPAC voted 16-2 to not recommend the booster for approval.

The booster dose represents a single shot of the 0.3 mL approximately 6 months after the second dose in individuals 16 years and older.

The committee was asked to make a decision looking at the clinical trial C4591001, which compromised 329 participants, and determining if the safety and effectiveness of the data would support approval.

During the meeting, they discussed the data related to the booster doses, breakthrough infections, and safety.

Sarah Oliver, MD, MSPH, Centers for Disease Control and Prevention Division of Viral Disease, National Center for Immunization and Respiratory Diseases, discussed vaccine rates, hospitalizations, and vaccine effectiveness. 

To date, 380 million total vaccine doses administered, and the breakout in terms of the percentage of the population fully vaccinated for ages is the following:

From January to July of this year,COVID-19 hospitalization rates were 23 times higher in the unvaccinated in the 18-49 age group; 22 times higher in the unvaccinated in the 50-64 age group; and 13 times higher in the unvaccinated in those aged 65 years and older.

The vaccines’ effectiveness dropped considerable from the plus 90% range prior to the emergence of the Delta variant to dropping several percentage points after that strain became the predominant variant.

Later two Israeli investigators presented data regarding how that country dealt with an increase of COVID-19 and their booster strategy in order to try to stop it.

Sharon Alroy Preis, MD, MPH, MBA, director of Public Health Services, Ministry of Health, Israel during her presentation said Israel was vaccinated earlier than most other countries and up to 3 months before 

In the summer they saw a 10 fold increase in one month.

Ron Milo, Ph.D., Professor, Weizmann Institute, Israel also presented.

Their booster data they reported showed the following:

Milo said there was “significant protection” with booster doses

He explained that if VE after waning is 50 for infection and increases 10-fold it become 95%. If VE after waning is 80 for infection and increases 10-fold it becomes greater than 97%

When asked about follow-up booster doses Preis said it was too early to determine if people will need to be vaccinated every 6 months.

William C. Gruber, MD, senior vice president, Vaccine Clinical Research and Development Pfizer, presented for the company and said that immunity waned 6-8 months after the second dose when Delta variant is the predominant strain. In addition, a retrospective study showed that vaccine effectiveness (VE) decreased primarily due to waning vaccine induced immunity rather than due to Delta escaping vaccine protection. 

Joohee Lee, MD, from the FDA, said the breakthrough infections happened more frequently to those who were vaccinated earlier than later. During her presentation Lee noted that immunogenicity data to support the effectiveness of the booster dose against the Delta variant are limited to exploratory analysis in a small number of participants using non-validated assays.

In the afternoon session during the public hearing people making presentations were mostly skeptical against the idea of a booster. More than a few were complaining over the size of the number of participants (329), the very small amount people who were 65 and older (12 participants), and the limitations on the Pfizer and Israel data.

After the public comment, there was a question and answer period and a discussion amongst the committee members. Paul Offit, MD, commented that he might be reluctant to vote yes for everyone 16 years or older, but would be open to voting for those 65 years and older.

As the committee was deliberating over the data and had their questions answered, some members seemed more inclined to want more data and that the current evidence did not confirm the need for a booster dose.

This discussion led to the vote and the aforementioned result.

Articles

The VRBPAC voted 16-2 on Friday afternoon on the question they were presented.

FDA VRBPAC Votes Against Recommending Approval of Booster Dose of Pfizer-BioNTech COVID-19 Vaccine

Saskia v. Popescu, PhD, MPH, MA, CIC, is a hospital epidemiologist and infection preventionist. During her work as an infection preventionist, she performed surveillance for infectious diseases, preparedness, and Ebola-response practices. She holds a doctorate in Biodefense from George Mason University where her research focuses on the role of infection prevention in facilitating global health security efforts. She is certified in Infection Control and has worked in both pediatric and adult acute care facilities.

School is back in session and with conversations surrounding boosters, the Delta variant, and when we’ll be able to vaccinate more children, we’re entering uncharted territory in the United States for the COVID-19 pandemic.

As we inch closer to two years of the COVID-19 pandemic, we’re learning more about hospitalization and the impact of the disease on various patient populations. This year, many college students will be going back to campus and living in dorms, which many universities mandating. 

Like so many during this most recent surge, 

 have been impacted by the steep rise in cases. Now more than ever though, understanding outcomes for those infected and hospitalized with COVID-19 will be important. A new research letter published in 

 directly addressed the clinical outcomes in young adults who were hospitalized with COVID-19 across the United States. 

In those aged 18-24 within the United States, the research team analyzed clinical profiles and outcomes across 3,222 individuals. These young adults were hospitalized with COVID-19 between April 1 and June 30, 2020 utilizing the Premier Healthcare Database, which pulls data from 1030 US hospitals. The researchers used ICD-10 codes. To define outcomes and comorbidities and ultimately assessed over 780,000 discharges during this timeframe. The mean age was 28.3 years and 57.6% were men, and 57% were Black or Hispanic. 36.8% had obesity. 

The authors noted “During hospitalization, 684 patients (21%) required intensive care, 331 (10%) required mechanical ventilation, and 88 (2.7%) died. Vasopressors or inotropes were used for 217 patients (7%), central venous catheters for 283 (9%), and arterial catheters for 192 (6%). The median length of stay was 4 days (interquartile range, 2-7 days). Among those who survived hospitalization, 99 (3%) were discharged to a postacute care facility. Morbid obesity (adjusted odds ratio [OR], 2.30; 95% CI, 1.77-2.98; vs no obesity; 

 < .001) and hypertension (adjusted OR, 2.36; 95% CI, 1.79-3.12; 

 < .001) were common and in addition to male sex (adjusted OR, 1.53; 95% CI, 1.20-1.95; 

 = .001) were associated with greater risk of death or mechanical ventilation. Odds of death or mechanical ventilation did not vary significantly with race and ethnicity. Morbid obesity was present in 140 patients (41%) who died or required ventilation. Diabetes was associated with increased risk of this outcome in univariable analysis (OR, 1.82; 95% CI, 1.41-2.36; 

 < .001) but did not reach statistical significance after adjustment (adjusted OR, 1.31; 95% CI, 0.99-1.73; 

When we look at these findings regarding hospitalized young adults, we find a considerable amount of substantial rates of adverse outcomes. 21% of the hospitalized young adults required intensive care and 10% needed mechanical ventilation. 

Overall, this indicates that young adults can and do experience severe outcomes and now more than ever, we need to invest in vaccination campaigns and prevention strategies that would target this patient population.

A new study addressed the clinical outcomes in young adults who were hospitalized with COVID-19 across the United States.

Understanding Young Adult Hospitalizations in COVID-19

The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be meeting today to address the FDA supplemental Biologics License Application (sBLA) for the booster dose of the BNT162b2 (Comirnaty) Pfizer-BioNTech vaccine that was submitted in late August.

“A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines. The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Research and Evaluation, said in a statement about the Pfizer-BioNTech booster dose.

During today’s meeting, the VRBPAC committee will vote to either recommend the booster dose or vote against it. Generally speaking, the FDA listens intently to the VRBPAC’s recommendations, and it could play a large role in the immediate future with the booster strategy that public health officials and the Biden Administration are looking to roll out this month.

The meeting could set the tone for the Biden Administration’s COVID-19 plan, which has been meeting to discuss a strategy that largely includes booster shots for people who have been vaccinated earlier this year and the rollout of the booster doses beginning on Monday.

Certainly there is some commentary coming from public health officials this past week  that can lead to the general public’s confusion or indecision on whether to get a booster dose. Although it is important to present all the data and opposing information, it can lead to inertia by the general public who do not know what to do with the varying, conflicting messages.

Earlier this week, a group of scientists came out against booster doses after reviewing the current data from randomized controlled trials and observational studies. The scientists included people from the World Health Organization (WHO) and the Food Drug Administration (FDA).

 summarized the currently available evidence published in peer-reviewed journals and pre-print servers.

“The vaccines that are currently available are safe, effective, and save lives. Although the idea of further reducing the number of COVID-19 cases by enhancing immunity in vaccinated people is appealing, any decision to do so should be evidence-based and consider the benefits and risks for individuals and society. These high-stakes decisions should be based on robust evidence and international scientific discussion,” co-author Soumya Swaminathan, MBBS, MD, chief scientist WHO, said.

The National Institutes of Health is one example of promoting the other side of the issue. Anthony S. Fauci, MD, director of the National Institution of Allergy and Infectious Diseases (NIAID), and chief medical advisor to the Biden Administration did not agree with the assessment made by the aforementioned group and said there is waning immunity against COVID-19 infection and evidence a booster dose is warranted.

No matter the outcome of today’s VRBPAC vote or the eventual FDA decision to either approve or not approve booster doses, one thing remains: COVID-19 and the continuation of the pandemic as it continues to create pain and suffering to patients, and a huge burden on the medical infrastructure in some areas.

A Food and Drug Administration (FDA) committee will discuss this topic as it pertains to the potential approval of a third dose of the Pfizer-BioNTech COVID-19 vaccine. The results of this meeting could have ramifications for the Biden Administration’s COVID-19 health policy.

FDA Meeting Today to Discuss Booster Doses

Kevin Kunzmann is the managing editor for 

. Prior to joining parent company MJH Life Sciences in 2017, he worked as a health care and government reporter for The Pocono Record, and as a freelance writer for NJ Advance Media, The Express-Times, The Daily Journal, and more. He graduated from Rowan University with a degree in journalism in 2015. In his spare time, he enjoys reading, cooking, running his dog, and complaining about the Mets. Follow him on Twitter 

The US Food and Drug Administration (FDA) has revised the previous emergency use authorization (EUA) granted to co-administered bamlanivimab and etesevimab to include an emergency use as post-exposure prevention for 

 in adults and pediatric patients ≥12 years old who are at high risk of progression to severe COVID-19.

The indication, granted to Eli Lilly, expands the authorized utility of the combination monoclonal antibodies, which were initially granted an EUA for the treatment of mild-to-moderate COVID-19 in the same patient population who tested positive for SARS-CoV-2 and were deemed at risk of progression to severe disease.

The FDA stressed in announcing the newest authorized that combination bamlanivimab and etesevimab are not approved as a pre-exposure prophylaxis to prevent COVID-19 prior to SARS-CoV-2 exposure, and that the post-exposure authorization should not be deemed as a viable substitute for vaccination against COVID-19:

Patients eligible for post-exposure prophylaxis with bamlanivimab and etesevimab must meet the following requirements:

Be deemed at high risk of progression to severe COVID-19, including hospitalization or death.

Not be fully vaccinated or expected to mount an adequate immune response from SARs-CoV-2 vaccination, such as those with immunocompromising conditions or those taking immunosuppressant medication.

Have been exposed to an individual infected with SARS-CoV-2 consistent with CDC criteria for “close contact” or be at high risk of exposure to an infected individual due to compromising settings such as long-term care facilities or prisons.

 for its initial indicated use of COVID-19 treatment in February 2019, on the basis of randomized, double-blinded, placebo-controlled trial data showing the single intravenous combination therapy significantly reduced hospitalization and death related to COVID-19 during 29 days of post-treatment follow-up versus placebo.

The emergency authorization granted to combination bamlanivimab and etesevimab is the second indicated in this last year.

FDA Authorizes Monoclonal Antibodies for Post-Exposure COVID-19 Prevention

Jonna Lorenz is a freelance journalist with more than 20 years of experience. Her background is in business and health care news, including reporting, editing and research for newspapers and websites.

The amount of time before veterans hospitalized with sepsis receive antibiotics declined in recent years, but varied significantly between VA hospitals, a recent study found.

, included 111,385 hospitalizations for sepsis at 130 VA hospitals from 2013 to 2018. The primary outcome was time-to-antibiotics across study periods, hospitals and patient subgroups based on presenting temperature and blood pressure.

“We found that overall, patients with sepsis are receiving antibiotics faster over time. However, the timing of antibiotics varied between hospitals, even after accounting for differences in patient characteristics,” lead author Max Wayne, MD, fellow in pulmonary and critical care medicine at the University of Michigan, told 

The vast majority (96.6%) of the patients were men, the average age was 68, and most common comorbid conditions included acute kidney dysfunction, elevated lactate and thrombocytopenia. Most patients (68.7%) received their first dose of antibiotics in the emergency department. A total of 7574 patients (6.8%) died in the hospital, and longer time-to-antibiotics was associated with higher in-hospital mortality. A total of 13,855 patients (12.4%) died within 30 days of discharge.

The median time-to-antibiotics (adjusted for patient characteristics) declined by 9 minutes per calendar year but varied significantly between hospitals, with average time-to-antibiotics in the most recent time period ranging from 3.1 hours to 6.7 hours.

Overall, the unadjusted median time-to-antibiotics decreased from 4.5 hours in the first year of the study to 3.5 hours in the most recent year.

All patient subgroups saw similar temporal trends in time-to-antibiotics. Bigger differences were noted between hospitals, with those with the slowest time-to-antibiotics seeing the biggest decrease over time (16.6 minutes per year) and those with the fastest times decreasing by 7.2 minutes per year.

For patients in hospitals with faster time-to-antibiotics, the odds of receiving antibiotics within 3 hours increase by 65%.

Median time-to-antibiotics during the most recent year of the study (3.9 hours) varied depending on presenting characteristics.

“The paper really focused on hospital level trends over time,” Wayne said. “However, in the supplement, we looked at patient factors and we found that fever seemed to be a stronger driver of rapid antibiotics than low blood pressure.”

Patients with fever and hypotension saw the fastest median time-to-antibiotics (2.4 hours), followed by those with fever and normal blood pressure (2.9 hours), those without fever and with hypotension (3.6 hours) and those without fever and with normal blood pressure 4.3 hours).

“Our findings suggest that patients with more obvious signs of infection get antibiotics faster,” Wayne said. “However, it is important to be cognizant that some patients with subtle findings can nonetheless still be very sick due to infection and warrant early antibiotics.”

Fast administration of antibiotics has been associated with improved survival in previous studies, with growing attention on the importance of timely treatment.

 showed that artificial intelligence-based alerts led to faster administration of antibiotics among septic patients and reduced the duration of hospitalization.

Still, risks of overtreatment should be weighed.

“Next steps are to better characterize the trade-offs of incentivizing early antibiotics, realizing that there may be harm associated with this in the form of patient side effects, downstream infections, and antibiotic resistance,” Wayne said. “We also are aiming to better understand consequences of providing antibiotics for patients who are ultimately determined to have a noninfectious illness.”

In 2015, the Centers for Medicare and Medicaid Services implemented a core measure sepsis bundle, including initiating broad-spectrum antibiotics within 3 hours of diagnosis. A 

 found that the program was associated with increases in use of broad-spectrum antibiotics and suggested audits to ensure appropriate antibiotic de-escalation.

A recent study examining trends in time-to-antibiotics among veterans hospitalized with sepsis found that patients received antibiotics faster over time.

Average Time-to-Antibiotics Decreased for Veterans Hospitalized with Sepsis

Based on recent studies, the company sees benefits in administering booster doses.  

Moderna COVID-19 Vaccine Remains Effective, Shows Waning Immunity Several Months After

Recent data shows that all three COVID-19 vaccines being administered in the United States are showing high rates of vaccine effectiveness (VE). 

Vaccines Remain Effective Against Delta 

Though efficacy waned over months, protection from symptomatic and severe COVID-19 remained significant, with no new adverse event risks observed.

Pfizer COVID-19 Vaccine Shows Continued Efficacy, Safety at 6 Months

Higher HIV viral loads and additional heart disease factors increase the risk as well.  

Higher Risk of Sudden Cardiac Death in People with HIV

Johnson & Johnson’s vaccine regimen induced neutralizing antibody responses in 98% of participants 21 days after the second dose.

Investigational Ebola Vaccine Regimen Shows Immune Response in Kids and Adults 

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In a recent speech, Pfizer’s CFO says it might be a matter of weeks for submitting an application for children 6 months to 5 years old.

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A study from Mexico shows that maternal mortality increased nearly 60 percent during the COVID-19 pandemic, and reaffirms the importance of both COVID-19 and influenza vaccinations for pregnant women.

Maternity Mortality Increase During COVID-19 Affirms Value of Vaccination During Pregnancy

Greatest risk for infection among vaccinated may be at home rather than at work, researchers say.

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FDA VRBPAC Votes Against Recommending Approval of Booster Dose of Pfizer-BioNTech COVID-19 Vaccine

Understanding Young Adult Hospitalizations in COVID-19

FDA Meeting Today to Discuss Booster Doses

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Average Time-to-Antibiotics Decreased for Veterans Hospitalized with Sepsis

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