Kaiser Permanente Study Finds No Serious Reactions to Shingles Vaccine

The herpes zoster vaccine, also known as the shingles vaccine, is generally safe and well tolerated according to a Vaccine Safety Datalink study of 193,083 adults published online in the Journal of Internal Medicine.

More than 1 million people develop shingles every year in the United States. Shingles is a painful contagious rash caused by the dormant chickenpox virus which can reactivate and replicate, damaging the nerve system. The elderly are especially vulnerable because immunity against the virus that causes shingles declines with age.

The VSD project is a collaborative effort between the Centers for Disease Control and Prevention (CDC) and integrated care organizations, including Kaiser Permanente. The VSD project monitors immunization safety and addresses the gaps in scientific knowledge about any rare and serious events that occur following immunization.

This study examined adverse events after the zoster vaccine was administered to 193,083 adults aged 50 and older from Jan. 1, 2007, to Dec. 31, 2008. Vaccination data were retrieved from electronic health records and collected from eight managed care organizations participating in the VSD project.

Researchers found a small increased risk of local reactions from 1 to 7 days after vaccination. These findings corroborate clinical trials of the vaccine in which there was evidence of a minor local reaction at the injection site in the form of redness and pain.

The study found no increased risk for cerebrovascular diseases; cardiovascular diseases; meningitis, encephalitis, and encephalopathy; Ramsay-Hunt syndrome; or Bell's palsy.

"It's good to know there is no serious adverse reaction to the zoster vaccine. The study supports the CDC's Advisory Committee on Immunization Practices (ACIP) recommendation and reassures the general public that the vaccine is safe," says study lead author Hung Fu Tseng, PhD, MPH, a research scientist with the Kaiser Permanente Southern California Department of Research & Evaluation in Pasadena, Calif.

The herpes zoster vaccine was licensed in 2006, but few people have been vaccinated, national data shows. The ACIP recommends the vaccine for healthy people ages 60 years and older. In 2011, the U.S. Food and Drug Administration approved the use of the herpes zoster vaccine in individuals 50 to 59 years of age. The study results released today provide important safety data for people in this age group as well as adults 60 and older.

This is the latest in a series of published Kaiser Permanente studies conducted to better understand vaccine effectiveness and safety. Among these studies were:
 
- Tseng published a study last year in the journal Vaccine which found that administering both the pneumococcal and the herpes zoster vaccines at the same time is as beneficial as if they are administered separately.

- In 2011, Tseng published a study in the Journal of the American Medical Association which found that the shingles vaccine is associated with a 55 percent reduced risk of developing the disease.

- Another study by Tseng in JAMA in 2010 found the pneumococcal pneumonia vaccination is not associated with a reduced risk of heart attacks or strokes in men.

- Two Kaiser Permanente studies found that the combination vaccine for measles, mumps, rubella, and chickenpox is associated with double the risk of febrile seizures for 1- to 2-year-old children, compared to same-day administration of the separate vaccine for MMR (measles, mumps, rubella) and the varicella vaccine for chickenpox.

- Other Kaiser Permanente studies found children of parents who refuse vaccines are nine times more likely to get chickenpox and 23 times more likely to get pertussis commonly known as whooping cough -- compared to fully immunized children.

- Another study found that herpes zoster is very rare among children who have been vaccinated against chickenpox.

The Vaccine Safety Datalink Team authors included: Hung Fu Tseng, PhD, MPH, Steven J. Jacobsen, MD, PhD, Amy Liu, MS, Lina Sy, MPH, and S. Michael Marcy, MD, from the Kaiser Permanente Southern California Department of Research & Evaluation; Bruce Fireman (MA) and Roger Baxter (MD), from Kaiser Permanente Northern California, Vaccine Study Center; Sheila Weinmann (PhD) from Kaiser Permanente Northwest, Portland, Ore.; Matthew F. Daley (MD) from Kaiser Permanente Colorado, Denver; Eric Weintraub (MPH) and James Baggs (PhD), from the Centers for Disease Control and Prevention Immunization Safety Office, Atlanta; James Nordin (MD) from HealthPartners Research Foundation, Minneapolis, Minn.; and Lisa Jackson (MD, MPH) from Group Health Cooperative of Puget Sound, Seattle.