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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 4 | Issue 6
March 15, 2022

Chief Author: Dana Ranallo, PharmD
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate

Clinical Pharmacy Update

Effectiveness of Pfizer-BioNTech COVID-19 Vaccine in Children and Adolescents Studied

On March 4, 2022, the Centers for Disease Control and Prevention (CDC) published a study reporting on the effectiveness of the Pfizer-BioNTech COVID-19 vaccine in children and adolescents 5-17 years old. In previously conducted clinical trials, which included children and adolescents ages 5-17, the efficacy of the vaccine against laboratory-confirmed COVID-19 was greater than 90%. A lack of real-world data on overall vaccine effectiveness and effectiveness against the Omicron variant prompted a need for this study, in which the CDC examined 39,217 emergency department (ED) and urgent care (UC) encounters, and 1,699 hospitalizations of patients ages 5-17. The full study included the pre-Delta, Delta and Omicron predominant periods. Among adolescents ages 12-17, vaccine efficacy estimates were highest (76-83%) at 14-149 days after completion of the 2-dose vaccination series. Vaccine efficacy dropped significantly (38-46%) at 150 days after completion of the vaccination series. Administration of a third, booster dose, increased vaccine efficacy to 86% amongst adolescents ages 16-17. Children ages 5-11 experienced significantly lower vaccine efficacy (46%) when compared to those ages 12-17 but most encounters included in the study for children 5-11 occurred during the period dominated by the Omicron variant. When only comparing the Omicron variant, the efficacy rates were comparable to those seen in the adolescent groups ages 12-15 and 16-17, 45% and 34%, respectively. These study results are consistent with previous studies which found that vaccine efficacy among adults was lower during Omicron variant predominance, with an increase in efficacy upon administration of a third, booster dose. It is important to note that the difference in vaccine efficacy among the different age groups can be attributed to the timing of vaccine availability. The results of this study provide real-world evidence supporting the CDC recommendation that all children and adolescents remain up to date with the recommended COVID-19 vaccinations. The Pfizer-BioNTech vaccine is currently FDA approved for use in anyone age 5 and older, with a third booster dose approved for those over age 12. 

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Drug Safety

FDA Announces Voluntary Recall of Normal Saline Injection Due to Potential Sterility Concerns

On March 3, 2022, the U.S. Food and Drug Administration (FDA) announced B. Braun Medical Inc.’s nationwide voluntary recall of five lots of 0.9% Sodium Chloride 250 ML IV bags at the hospital and user level. Normal saline, or 0.9% Sodium Chloride, is used to restore water or sodium losses for several indications such as dehydration and low sodium concentration in blood, along with other conditions. The recall was initiated due to fluid leakage and low fill volume of the containers which may cause breach in sterility of the products. A break in sterility poses risks of bacterial or fungal infection, and in rare instances, serious bloodstream infection. To date, no reports of product complaints or adverse events associated with the recall have been made to B. Braun. The company is also notifying its distributors and customers about the recall. Distributors have been advised to immediately discontinue use and follow through with return arrangements. Adverse reactions related to the recall should be made to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

FDA Expands Approval for Jardiance® in Patients with Heart Failure

On February 24, 2022, the FDA approved Jardiance® (empagliflozin) to reduce the risk of cardiovascular death and hospitalization in adults with heart failure. Jardiance® was first approved to lower blood sugar levels and to reduce the risk of cardiovascular related death in adults with type 2 diabetes and cardiovascular disease. It has also previously been given approval to reduce the risk of death and hospitalization in adults with heart failure with reduced ejection fraction. This new approval allows for the use of Jardiance® in all patients with heart failure, regardless of status of ejection fraction. Heart failure occurs when the heart is not able to pump enough blood and oxygen to meet the demands of the body. Ejection fraction is a measurement of the amount of blood pumped out of the heart with each heartbeat. Heart failure with reduced ejection fraction (HFrEF) occurs when the heart fails to contract properly, leading to a reduction in the amount of blood pumped throughout the body. In patients with heart failure with preserved ejection fraction (HFpEF), the heart becomes rigid and is unable to refill blood properly, also leading to a decrease in the amount of blood pumped out. Common heart failure symptoms include fatigue, chest pain, swelling in the legs, and shortness of breath. The expanded approval of Jardiance®, to cover patients with reduced or preserved ejection fraction heart failure, was granted after favorable safety and efficacy data was obtained in a randomized, double-blind, phase 3 clinical trial which compared 2,997 participants who received 10 mg Jardiance® daily with 2,991 participants who received placebo. Of the participants who received Jardiance® for an average of two years, 14% died from cardiovascular causes or needed to be hospitalized for heart failure, compared to 17% of participants who received placebo. This label expansion will provide physicians with another treatment option in adults with heart failure.

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FDA Approvals

New FDA Approvals

Novel Drug Approval: Vonjo™ (pacritinib)
Oral capsules approved for the treatment of adult patients with a rare bone marrow cancer called myelofibrosis and low blood platelet count. [02/28/2022 – Orphan DrugPriority Review – CTI BIOPHARMA CORP]

New Dosage Form: Aspruzyo Sprinkle™ (ranolazine)
Extended-release oral granules approved for the treatment of chronic chest pain in adult patients. [02/28/2022 – SUN PHARMA GLOBAL] 

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New Generics

New Generics Entering the Marketplace

Lanoxin® (digoxin)
Indication: Heart Failure
Dosage Form/Strength: 62.5 MCG Tablets
Average Wholesale Price (AWP): Generic = $466.51 | Brand: $518.40