Monday, 28 May 2018

You are here

New Zoster Vaccine Recommended by FDA Panel

Reuters reports that the Food and Drug Administration (FDA) advisory panel has voted 11-0 in favor of the safety and efficacy and ultimate approval of GlaxoSmithKline’s Shingrix shingles vaccine for use in adults aged 50 and over.

The proposed inactive vaccine against H. zoster (HZ) was previously reported to be more effective than the current live vaccine Zostavax made by Merck. (

The herpes zoster beta subunit vaccine was shown to be more than 90% effective (for 4+ years) in HZ prevention and post-herpetic neuralgia prevention, especially in those over age 70 yrs. - claims that exceed that seen with the current vaccine. 

Shingrix has the advantage of being an inactive (non-live) virus vaccine - that can be given to those who are immunosuppressed or receiving TNF inhibitors or other biologic agents.  Shingrix has not been studied in those who are immunosuppressed or receiving TNF inhibitors or other biologic agents.

GSK is forecasting sales for this product to reach $1 billion by 2023. In contrast, Zostavax, approved in 2006, is expected to generate sales of about $730 million this year. 

The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Tobacco Associated Deaths in the USA

JAMA Internal Medicine reports that in the USA, those who smoke cigar, pipe, or cigarette have a significant overall  mortality risk, and a much highers cancer mortality risk compared to nonsmokers.

The National Longitudinal Mortality Study collected baseline survey data from 1985 through 2011 and included 357,420 participants reporting on their use of cigar, pipes, or cigarettes.

MMWR: Cannabis Use in the Colorado Workers

MMWR reports that eight states, including Colorado, have legalized recreational marijuana for use by adults and that a study of use in Colorado has shown that nearly 15% of Colorado adult workers have used marijuana in the past 30 days. Use was highest among young adults, especially men, working in the Accommodation/Food Services and Food Preparation/Serving industries.

EMA to Review Methotrexate Overdose and Dosing Errors

A recent meeting (April 9-12) of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) considered the problem of dosing errors with methotrexate (MTX), citing "continued reports of overdose." 

2 Weeks Off Methotrexate OK for Flu Vaccine

Stopping methotrexate for 2 weeks after the administration of flu vaccine led to improved immunogenicity without increasing disease activity among patients with rheumatoid arthritis (RA), a prospective Korean study showed.

Risk of Paternal Exposure to Anti-Rheumatic Drugs

Seminars in Arthritis and Rheumatism features a review of the effects of paternal use of antirheumatic drugs on pregnancy, specifically addressing the effects of NSAIDs, steroids, DMARDs and biologics on spermatogenesis and the effect on pregnancy outcomes and offspring.