Shingrix Vaccine Reported Safe By CDC and FDA
Patients can be reassured of Shingrix vaccine initial post-licensure safety data
A new report published by the Centers for Disease Control and Prevention (CDC) said ‘Healthcare providers and patients can be reassured by the recombinant zoster vaccine Shingrix’s initial post-licensure safety data.’
This analysis was published on January 31, 2019, based on the Vaccine Adverse Event Reporting System (VAERS).
During the first 8 months of use, when approximately 3.2 million Shingrix doses were distributed, the VAERS received a total of 4,381 reports of adverse events.
Only 130 (3.0%) of which were classified as serious.
Commonly reported signs and symptoms included fever (23.6%), injection site pain (22.5%), and injection site erythema (20.1%).
The CDC said there were ‘no unexpected patterns detected in reports of adverse events or serious adverse events.’
And, these ‘findings are consistent with Shingrix’s safety profile observed in prelicensure clinical trials.’
Shingrix is produced by GlaxoSmithKline (GSK) and was approved by the US Food and Drug Administration in October 2017.
Shingrix is recommended for adults 50 and older to prevent shingles, which is a painful rash that affects 1 out of 3 Americans in their lifetime.
The previously licensed live-attenuated zoster vaccine, Zostavax, is recommended for adults aged ≥60 years.
VAERS is a national passive surveillance system for adverse events after administration of U.S.-licensed vaccines and is co-administered by CDC and FDA.
VAERS accepts reports from healthcare providers, vaccine manufacturers, and the public.
VAERS reports are classified as “serious” according to Code of Federal Regulations Title 21 Section 600.80. Medical records are requested for reports of serious adverse events, including autopsy findings and death certificates for reported deaths.
CDC and FDA investigators conducted descriptive analyses of reports to VAERS involving Shingrix for the period October 20, 2017–June 30, 2018. During the analytic period, VAERS received 4,381 reports, for a rate of 136 reports per 100,000 doses distributed; among these, 130 (3.0%) were classified as serious.
For 4,167 (95.1%) reports, Shingrix was the only vaccine that had been administered.
Seven confirmed deaths after receipt of Shingrix were reported. According to records, the median decedent age was 65 years, and the interval from vaccination to death ranged from 6 hours to 6 weeks.
The cause of death in four persons was cardiovascular disease, three of whom had multiple cardiac risk factors. Two persons, both of whom were immunosuppressed, died of septic shock.
One death occurred in a woman (aged 86 years) who died subsequent to a fall.
No Shingrix-adverse event pairings met the statistical threshold for an empirical Bayesian data mining finding of a potential safety signal.
Previously, during February 2018, the American Pharmacist Association published a key difference comparison chart between the two herpes zoster vaccines.
And, a list of questions regarding Shingrix was published during October 2018.