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Pulse Newsletter

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

Volume 3 | Issue 19
October 1, 2021

Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Use in Select Populations

On September 17, 2021, the U.S. Food & Drug Administration (FDA) held a public meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) which is composed of independent, external experts. The vaccine manufacturer presented data on the use of a third dose of its vaccine, seeking approval for use in all individuals 16 years and older. The data was evaluated by the FDA advisory committee as well as other international and U.S. agencies and external groups, including the Centers for Disease Control and Prevention (CDC). After evaluating all currently available data, the FDA, with guidance from its advisory committee, determined that the potential benefits of a booster dose outweighed the known and potential risks, in certain populations. The booster dose is the same dose and formulation as the initial vaccines and may be used interchangeably. Subsequently, on September 22, 2021, the FDA updated its emergency use authorization (EUA) of Pfizer-BioNTech’s COVID-19 vaccine to allow for a third, booster dose to be administered at least 6 months after completion of the initial 2-dose series in certain individuals. Individuals who are eligible for a booster shot include those who are 65 years and older, between 18-64 years and at high risk of severe COVID-19 disease, and those 18-64 years who are at high risk of serious complications related to COVID-19 due to frequent exposure in an institutional setting or at their occupation. As of September 26, 2021, no updates or changes have been made to the approvals of the other COVID-19 vaccines available on the U.S. market.

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Drug Safety

Jacobus Issues Worldwide Recall of Ruzurgi® Tablets Due to Contamination

On September 13, 2021, the FDA announced Jacobus Pharmaceutical Company Inc.’s voluntary worldwide recall of three lots of Ruzurgi® (amifampridine) 10 mg oral tablets as a result of laboratory test results that showed the affected products were contaminated with yeast, mold and bacteria. Amifampridine is used for the treatment of Lambert Eaton Syndrome (LEMS) in pediatric patients 6-16 years. LEMS is a rare, autoimmune condition in which a person’s immune system attacks the junctions where nerves and muscles connect, disrupting the ability of nerve cells to send signals to muscle cells, which often causes weakness and other symptoms in affected individuals. Ingesting heavily contaminated product may result in serious and life-threatening infections, especially in patients with weakened immune systems. The company is notifying its distributors and customers of the contamination and has provided instructions for returning all recalled products. All consumers and patients in possession of the affected lots should discontinue use and contact Jacobus to schedule for returns. Individuals who experience any problems related to using this product should contact their physician or health care provider and adverse reactions or quality problems related to the recall should be made to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Pfizer Submits for Approval of COVID-19 Vaccine in Children

Pfizer-BioNTech has submitted clinical trial data on September 28, 2021, seeking approval of COVID-19 vaccines for emergency use in children ages 5-11 years. Currently, Pfizer-BioNTech’s vaccine is fully approved for individuals 16 years and older and is available through emergency authorization for people 12-15 years. On September 20, 2021, Pfizer announced that the results of their clinical trial demonstrated strong immune response with similar efficacy and safety compared to older groups who received the vaccine. The clinical trial included 2,268 participants ages 5-11 years using a two-dose regimen administered 21 days apart. The trial used a third of the dose currently used for individuals aged 12 years and older. If the Pfizer-BioNTech COVID-19 vaccine is approved for children ages 5-11 years, more than 28 million people would be newly eligible to be vaccinated. The FDA continues to review the trial data and Pfizer-BioNTech is expected to make a formal request for emergency use of the vaccine in the coming weeks. With rapid authorization, the vaccine could be approved as early as the end of October.

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FDA Approvals

New FDA Drug Approvals

Novel Drug Approval: Exkivity™ (mobocertinib)
Oral capsules approved for the treatment of adult patients with progressed non-small cell lung cancer (NSCLC) with a specific gene mutation that causes cancer cells to grow more rapidly. [09/15/21 – Priority Review; Orphan Drug – TAKEDA PHARMS USA]

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New Generics

New Generic Medications Entering the Marketplace*

Bystolic® (nebivolol hydrochloride)
Indication: High blood pressure
Dosage Form/Strength: 2.5, 5, 10, and 20 MG Tablets
Average Wholesale Price (AWP): Generic = $170  | Brand = $190