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Amid continuing concerns about reports of problems with the single-dose Zostavax shingles vaccine, a new report reviewed adverse reactions to the newer, double-dose Shingrix vaccine, indicating that about three percent of those reactions resulted in serious injuries or complications.
GlaxoSmithKline’s Shingrix vaccine is believed to be safer and more effective for prevention of shingles among older adults, and has largely replaced the older live-virus Zostavax vaccine, which has been linked to reports of more severe and persistent shingles outbreaks and auto-immune complications in recent years.
In the latest issue of the U.S. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR), health officials indicate that at least 4,381 reports of adverse events have been received involving shingles inoculation with Shingrix, about 130 of them are classified as serious, including seven deaths. However, it is unclear whether the deaths were tied directly to the vaccine.
Shingrix (recombinant zoster vaccine; RZV) was introduced in October 2017, and has been approved for prevention of shingles among adults age 50 and older. It was the second shingles vaccine approved in the U.S., and has been widely viewed as a superior replacement for Merck’s Zostavax (zoster vaccine live; ZVL), which has been linked to complications as a result of an “under-attenuated” live virus contained in the vaccine.
The MMWR findings come from data lifted from the Vaccine Adverse Event Reporting System (VAERS) during the first eight months Shingrix was in use, from October 20, 2017 to June 30, 2018, resulting in the distribution of 3.2 million doses. The most common adverse events were fever, injection site pain, and injection site erythema. The report does not highlight any specific side effects which stood out among the reports of serious adverse events. However, the report does indicates that 196 patients developed shingles even after receiving the vaccine, though the CDC indicates that it believes 14 of those patients may have already been suffering from a shingles outbreak when they received the shot.
CDC researchers said that the Shingrix success rate was above 90%, which, combined with the total number of adverse events, puts Shingrix in line with most vaccines, meaning it is overwhelmingly safe. However, the shot has been linked to numerous injection site errors.
The findings come several months after the CDC issued a warning highlighting the number of adverse event reports submitted in recent months involving Shingrix administration errors, which resulted in injection site problems and other complications.
That warning indicated that 155 reports were submitted to the Vaccine Adverse Event Reporting System during the first four months Shingrix was available, including at least 13 problems with Shingrix administration. According to the findings, nine of those errors were because the drug was administered in a single subcutaneous dose, instead of as a 2-dose intramuscular injection, which is how the vaccine should be given. The single subcutaneous dose is how Zostavax is administered, suggesting confusion among doctors.
All but one of those patients suffered injection site reactions, including pain, erythema, and pruritus.
As of this latest MMWR report, the number of reported injection errors had risen to 230.
Zostavax Side Effects
The findings come as Merck faces a growing number of Zostavax lawsuits filed in courts throughout the U.S., each involving similar allegations that the manufacturers of that older shingles vaccine failed to warn consumers and the medical community that the live-virus contained in the injection was not sufficiently weakened to prevent re-activation of the dormant virus in some users.
According to allegations raised in the complaints, following inoculation with the Zostavax shingles vaccine, users may develop a more severe and persistent version of shingles, or other complications, including Guillain-Barre syndrome, acute disseminated encephalomyelitis (ADEM), transverse myelitis, meningitis, facial paralysis, vision problems and other injuries.
Last month, a study was also published in The BMJ, which found that Shingrix is 85% more effective at preventing shingles than Zostavax, further accelerating the move away from Zostavax by many doctors in recent years.