Serious adverse events rare for Shingrix, says new CDC data
CDC researchers concluded in a February 1 Morbidity and Mortality Weekly Report that recent safety monitoring for the recombinant zoster vaccine ([RZV] Shingrix—GlaxoSmithKline), which was licensed in October 2017, are consistent with prelicensure clinical trial data—meaning that serious adverse events were rare.
The postmarketing voluntary reporting, which was recorded in the national Vaccine Adverse Event Reporting System, found that of the roughly 3.2 million doses of the vaccine distributed during the first 8 months of use, 4,381 adverse events were reported, including fever, injection-site pain, and injection-site erythema. Only 3% of the adverse reactions were considered serious. The zoster vaccine live (Zostavax—Merck), the old version, had a slightly higher serious event rate.
According to the report’s authors, “Health care providers and patients can be reassured by RZV’s initial postlicensure safety data. Counseling patients to expect self-limited adverse reactions such as pain, swelling and redness at the injection site, fever, chills, and body aches might ease concerns and encourage completion of the two-dose RZV series.”
Recommended for adults aged 50 years and older, RZV is administered intramuscularly as a two-dose series, with an interval of 2 to 6 months between doses.