John Parkinson

This article was originally published in ContagionLive.

New guidance from the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) includes 3 new evidence-based guidelines for the treatment of 

The guidelines, developed by a multidisciplinary panel with representatives from IDSA and SHEA and announced on June 24, include 3 recommendations on suggested treatments for patients with initial and recurring CDI episodes, based on new data for fidaxomicin and for bezlotoxumab, a monoclonal antibody targeting toxin B produced by 

The guidelines call for patients with an initial CDI to be treated with fidaxomicin as opposed to vancomycin.

According to the panel, the recommendations are the result of systematic review of available evidence and an assessment of the benefits and harms of alternative care options.

The panel adhered to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence and strength of recommendations.

The guidelines are intended to aid clinicians in determining which treatments are best for individual patient scenarios.

Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults

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IDSA and SHEA released 3 new evidence-based recommendations for treating CDI.

New C Difficile Guidelines Prioritize Fidaxomicin

 vaccine has reached the immunogenicity endpoint in a phase 2/3 of pediatric patients aged 12-17.

This news comes from their TeenCOVE study, which enrolled more than 3700 adolescents in the United States. The company reports that for fully vaccinated participants (2 doses administered) no cases of COVID-19 were reported. In the placebo group, 4 cases were observed.

“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection, ”Moderna CEO Stéphane Bancel, Moderna, said.

The mRNA-1273 vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the 

 in adults. No significant safety concerns have been identified to date. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of the vaccine were headache, fatigue, myalgia and chills.

With this new data, Moderna plans to file for authorization. “We will submit these results to the US FDA and regulators globally in early June and request authorization,” Bancel said. “We remain committed to doing our part to help end the COVID-19 pandemic.”

The company expects to file for FDA authorization for the 12-17 year old population in June. 

Moderna Touts COVID-19 Efficacy for Pediatric Patients

The first COVID-19 vaccine to receive an Emergency Use Authorization (EUA) might be the first to garner full US Food and Drug Administration (FDA) approval in the US.

Pfizer-BioNTech announced on May 7 they are initiating the submission process for a Biologics License Application (BLA) for their COVID-19 vaccine.

"We are proud of the tremendous progress we've made since December in delivering vaccines to millions of Americans, in collaboration with the US government," Chairman and CEO of Pfizer Albert Bourla, said in a statement. "We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months."

While the vaccine has been available for 6 months due to the EUA, this move to apply for the BLA solidifies the standing of the vaccine and would be the official government approval of the vaccine.

According to the FDA, a “BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA.”

In order to complete the process, companies need to have applicant information, product/manufacturing information, pre-clinical studies, clinical studies, and labeling.

The timetable for the approval is open-ended but is expected to take months to complete as regulators will analyze data and other aspects of the application.

The companies announce plans to submit a Biologics License Agreement for the mRNA-based vaccine.

 Pfizer-BioNTech Hoping for Full FDA Approval for COVID-19 Vaccine

A new report from the US Centers for Disease Control and Prevention (CDC) highlights extensive efficacy in preventing infections from the Moderna and Pfizer-BioNTech 

The report shows the 2 vaccines were 90% effective in preventing infections—regardless of symptom status—14 days after the second dose was administered.

In addition, the 2 vaccines were 80% effective 14 days after the first dose, but before the second dose.

The findings come from studying nearly 4000 health care personnel, first responders, and other frontline workers from mid-December 2020 through mid-March 2021. The participants were tested weekly for 13 weeks in 8 US locations.

According to the CDC, both vaccines were given to participants in all the locations, but the timing on their availability differed. Of the vaccinated, 62.7% of participants received the Pfizer-BioNTech shot and 29.6% received the Moderna shot.

In addition, more data from these studies is showing that transmission is unlikely from people who have been vaccinated.

“Among fully immunized (≥14 days after second dose) persons, 0.04 infections per 1000 person-days were reported, and among partially immunized (≥14 days after first dose and before second dose) persons, 0.19 infections per 1000 person-days were reported,” the CDC stated on their website.

Obviously, this comes as optimistic news in light of some surging cases in various parts of the US and the concern of the B.1117 variant—first discovered in the United Kingdom—is becoming the dominant strain.

“These findings indicate that authorized mRNA COVID-19 vaccines are effective for preventing SARS-CoV-2 infection, regardless of symptom status, among working-age adults in real-world conditions,” the CDC stated.

In a 4000 person study, investigators find vaccinated individuals unlikely to transmit COVID-19.