Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

Miranda Hester

 Cosentyx (secukinumab) from Novartis Pharmaceuticals Corporation for the treatment of moderate-to-severe plaque psoriasis in children aged 6 years and older who are candidates for phototherapy or systemic therapy. It’s the first pediatric approval for secukinumab in the United States. The approved pediatric doses are 75 mg or 150 mg, dependent on the child’s weight, and is administered via subcutaneous injection every 4 weeks following an initial loading dose. Following counseling and training in injection, secukinumab can be given to a child by an adult caregiver.

The approval was based on the results from 2 trials. The first trial was 52 weeks and was a randomized, double-blind, placebo- and active-controlled study of 16 randomized, double-blind, placebo- and active-controlled study of children aged 6 years of age who had severe plaque psoriasis. In the trial, secukinumab reduced psoriasis severity at Week 12 when compared to the placebo. The other Phase III study was a randomized open-label, 208-week trial of 84 children aged 6 years and older who had moderate-to-severe plaque psoriasis.

The most common side effects seen with secukinumab are upper respiratory infections, diarrhea, and cold symptoms.

In a release for the approval, Randy Beranek, President and CEO, National Psoriasis Foundation. "Having expanded treatment options for this patient population is a step in the right direction to help reduce the burden of plaque psoriasis."

This article was originally published by 

1. Novartis Pharmaceutical Corporation. Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis. Published June 1, 2021. Accessed June 2, 2021. https://www.prnewswire.com/news-releases/novartis-cosentyx-receives-fda-approval-for-treatment-of-children-and-adolescents-with-moderate-to-severe-plaque-psoriasis-301303365.html

Articles

The FDA approved Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis in children aged 6 years and older.

FDA OKs Secukinumab for Children Aged 6 and Older

 that the phase 2/3 study of the company’s COVID-19 vaccine has reached its end point.

 No cases of COVID-19 were seen in in participants who had both doses. The data will be submitted to regulators in the next few weeks.

The trial included 3732 participants aged 12 to <18 years who were randomized 2:1 to either receive a placebo or 2 100 µg doses of the Moderna vaccine. Following 2 doses, no cases were found in the vaccine group versus 4 cases in the placebo group. Due to the lower incidence rate of COVID-19, the investigators also used the secondary CDC case definition, which needs just 1 COVID-19 symptom and a nasopharyngeal swab or a saliva sample that was positive for COVID-19. An efficacy of 93% was seen after 14 days following the first dose when using the secondary CDC case definition.

The vaccine safety profile was similar to what was seen with adults. No major safety concerns have been identified so far. Most adverse events have been mild or moderate in severity and the most common local adverse event was pain at the injection site. Following the second dose, the most common systemic adverse events were fatigue, chills, myalgia, and headache.

This article was originally published on Contemporary Pediatrics. 

1. Moderna announces TeenCOVE study of its COVID-19 vaccine in adolescents meets primary endpoint and plans to submit data to regulators in early June. News Release. Moderna; May 25, 2021. Accessed May 25, 2021. 

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-teencove-study-its-covid-19-vaccine

The company has publicized data from the TeenCOVE study of the vaccine along with plans to seek authorization in the coming weeks.

Moderna COVID-19 Vaccine Appears Effective and Safe in Adolescents

Although COVID-19 vaccine rollout has expanded rapidly for many adults and a small subset of the older pediatric population, the majority of children remain unable to be vaccinated. Pfizer/BioNTech has just 

 from their Phase 3 study of participants aged 12 to 15 years.1 The companies indicated that they will be submitting the data as soon as possible to the US Food and Drug Administration for emergency use authorization in the expanded group.

The trial included 2260 participants aged 12 to 15 years who live in the United States. There were 18 cases of COVID-19 in the placebo group (n = 1129) and 0 cases in the group that received the vaccine (1131). Receiving the vaccine generated severe acute respiratory syndrome coronavirus 2-neutralizing antibody geometric mean titers of 1,239.5, which is comparable to the geometric mean titers seen in the participants aged 16 to 25 years in the Phase 3 study released in November 2020. The side effects were also similar to the participants aged 16 to 25 years in that earlier trial.

The release also noted that the first doses have been administered in their trial for children aged 6 months to 11 years. The trial is split into 3 cohorts: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years. The first dose of the vaccine has been administered to the 5 to 11 years cohort and the 2 to 5 years cohort is expected to receive their dose next week. The vaccine is administered with a 21 day gap between the doses.

1. Pfizer. Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents. Published March 31, 2021. Accessed March 31, 2021. 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal

Pfizer/BioNTech released data on their COVID-19 vaccine that indicates high efficacy in children aged 12 to 15 years. 

Pfizer-BioNTech COVID-19 Vaccine Shows High Efficacy in Adolescents

The Centers for Disease Control and Prevention (CDC) have produced the first set of 

 for people who have received either 2 doses of the Pfizer/BioNTech or Moderna vaccine or the 1 dose of the Johnson & Johnson/Janssen vaccine.

For the purposes of the guidance, a person is considered fully vaccinated for COVID-19, ≥2 weeks after receiving the second dose of the 2-dose vaccines and the ≥2 weeks after receiving the vaccine of the single-dose vaccine. The recommendations are also only for non-health care settings.

Visit with other fully vaccinated people in an indoor space without mask wearing or social distancing.

Visit with unvaccinated people from a single household without mask wearing or social distancing, if the unvaccinated people are at low risk for severe COVID-19 disease

Abstain from quarantine and testing after a known exposure, if the exposure was to asymptomatic people.

The guidance also recommends that fully vaccinated people continue to:

Wear a well-fitted face covering in public

Continue mask wearing, social distancing, and other infection control measures when visiting with unvaccinated people at increased risk of severe disease or if visiting with unvaccinated people from multiple households

Undergo testing if COVID-19 symptoms occur

Follow CDC and health department travel requirements

Continue avoiding medium- and large-sized in-person gatherings.

1. Centers for Disease Control and Prevention. Interim public health recommendations for fully vaccinated people. Published March 8, 2021. Accessed March 8, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

The CDC has issued interim guidance for masking, social distancing, hand hygiene, and other infection control measures for people who are fully vaccinated for COVID-19.