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Federal health experts are warning about the risk of problems with Shingrix, GlaxoSmithKline’s shingles vaccine, indicating that errors have been reported in recent months due to confusion between the new drug and its older competitor, Zostavax.
The U.S. Centers for Disease Control and Prevention (CDC) published a report this week in its Morbidity and Mortality Weekly Report (MMWR), highlighting the number of adverse event reports submitted in recent months involving Shingrix administration errors.
Shingrix (recombinant zoster vaccine; RZV) is a new GlaxoSmithKline shingles vaccine that was just placed on the market in October 2017. It is only approved for adults age 50 and older, and is one two shingle vaccines that are currently approved in the United States. The other is Merck’s Zostavax (zoster vaccine live; ZVL).
The report indicates 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.
In two cases, patients were given the vaccine information statement for Zostavax instead of for Shingrix, and not instructed to return for their second dose, which also suggests whoever administered the vaccine thought they were giving the patients Zostavax, or thought that Shingrix worked the same way.
In the other four cases, the patients given the vaccine were younger than the minimum age of 50, for which the vaccine is approved.
The CDC researchers suggest that early monitoring indicates that the vaccine providers are confused over administration procedures, and storage requirements of Shingrix. Nine of the 13 vaccine administration errors occurred in a pharmacy, while two happened in a health care provider’s office, and two occurred at unknown sites.
“To prevent RZV administration errors, vaccine providers should be aware of prescribing information, storage requirements, preparation guidelines, and (Advisory Committee on Immunization Practices) recommendations for herpes zoster vaccines,” the CDC report recommends.
Shingles Vaccine Problems
The report comes amid concerns over the potential side effects of Zostavax, another shingles vaccine that was introduced in May 2006. Merck now faces a growing number of Zostavax lawsuits, which claim that the drug not only fails to protect against shingles as advertised, but actually causes a more persistent strain of the infection.
According to allegations raised in dozens of product liability lawsuits filed over the shingles vaccine, Merck used an under attenuated live strain of the varicella zoster virus (VZV) in Zostavax, which was not weakened enough to prevent reactivation of the virus. Instead of the body developing the proper immune response, the live virus combined with the old virus in some users, resulting in a more virulent strain of shingles.
Zostavax sales have fallen sharply in recent years, while Shingrix sales have far surpassed original projections, with full year sales now projected to exceed $600 million for the new drug.
Shingles is caused by the same virus, varicella zoster, which causes chickenpox. Later in life, the virus can be reactivated and cause shingles, which is a painful rash that usually appears as a stripe of blisters on the body. Pain can continue even after the rash is gone, which is known as postherpetic neuralgia.
Shingles itself can cause scarring, bacterial infections, encephalitis, hearing loss, vision problems and other complications.