Study finds new pneumococcal vaccine appears to be as safe as previously used vaccine

May 22, 2013, Kaiser Permanente

The new 13-valent pneumococcal conjugate vaccine (PCV13) appears to be as safe as the previous version used prior to 2010, the 7-valent pneumococcal conjugate vaccine (PCV7), according to a Kaiser Permanente study published today in Vaccine.

The U.S. approved PCV13 for use beginning in 2010 after a series of trials. These trials found that PCV13, which protects against a broader range of pneumococcal types than the previously used PCV7, did not increase the risk for any related to the vaccine.

In a study funded by the , Kaiser Permanente researchers evaluated the of nearly 600,000 children, ages 1 month to 2 years, who received PCV13 over a two-year period. Comparing the number of rare adverse events associated with the PCV13 vaccine to the number of events associated with the previously used PCV7 vaccine, the study authors found there were no increased risks for any of the following pre-specified conditions: , encephalopathy (a type of brain disorder), hives/angioedema, asthma, low platelet counts or systemic allergic reactions.

"It is important that children receive the pneumococcal conjugate vaccine as it provides protection against very serious and potentially , including meningitis and bloodstream infections. The new vaccine protects against an additional six types of ," said study lead author Hung Fu Tseng, PhD, MPH, a research scientist at the Kaiser Permanente Southern California Department of Research & Evaluation.

Early in the study, there was a statistically significant but very small increase in the risk of Kawasaki's disease, a rare condition in children that causes inflammation of the blood vessels, associated with PCV13 (7 diagnoses per 52,000 doses, compared to 4.24 expected). At the end of the study, when the diagnoses were confirmed by medical-record review, the risk of Kawasaki disease in the 28 days following PCV7 was 1 per 100,000 doses and 2 per 100,000 doses of PCV13. Although this difference was not statistically significant, the researchers note it warrants further studies. Researchers also emphasized that this is a statistical association and therefore may not represent a cause-and-effect relationship.

The CDC recommends all children ages 5 years and younger receive PCV13. The vaccine protects against pneumococcal disease, an infection caused by Streptococcus pneumoniae. The most common types of pneumococcal infections include middle-ear infections, sinus infections, lung infections, bloodstream infections and meningitis. According to the CDC, each year in the U.S. pneumococcal bacteria cause about 4,000 cases of (bacteremia), , or other invasive disease in children younger than 5 years of age.

Researchers used medical records from the Vaccine Safety Datalink, a collaborative effort between the CDC and integrated care organizations, including Kaiser Permanente, to conduct the study. The Vaccine Safety Datalink project monitors immunization safety and addresses the gaps in scientific knowledge about any rare and serious events that occur following immunization.

This study is part of Kaiser Permanente's ongoing efforts to study the safety and effectiveness of vaccines. Last year, a Kaiser Permanente study conducted through the Vaccine Safety Datalink found the herpes zoster vaccine, also known as the shingles vaccine, is generally safe and well tolerated. Additionally late last year, Kaiser Permanente researchers found immunizing older adults with the tetanus-diphtheria-acellular-pertussis vaccine (Tdap) to prevent whooping cough was found to be as safe as immunizing them with the tetanus and diphtheria (Td) vaccine.

Explore further: Shingles vaccine is safe, according to new study

Related Stories

Shingles vaccine is safe, according to new study

April 23, 2012
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.

Study to test pneumococcal vaccine in older adults

October 15, 2012
Researchers plan to see if a higher dose of a pneumococcal vaccine will create a stronger immune response in older adults who received an earlier generation vaccine against pneumonia and other pneumococcal diseases.

Whole-cell vaccine was more effective than acellular vaccine during CA pertussis outbreak

May 20, 2013
Whole-cell pertussis vaccines were more effective at protecting against pertussis than acellular pertussis vaccines during a large recent outbreak, according to a new Kaiser Permanente study published in Pediatrics.

Nearly half of children under two years of age receive some vaccinations late

January 21, 2013
In a new study published today in JAMA Pediatrics (formerly Archives of Pediatrics and Adolescent Medicine), Kaiser Permanente researchers found that 49 percent of children ages 2-24 months did not receive all recommended ...

First European randomized trial confirms new pneumococcal vaccine highly effective in infants

November 15, 2012
A new conjugate vaccine is highly effective (93%) at preventing invasive pneumococcal disease (IPD; meningitis, sepsis, bacteremic pneumonia, and other blood-borne infections) in infants younger than 2 years who are the most ...

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.