News and Updates to Vaccines & Immunizations
July 2010
MMRV Vaccine Associated with Increased Risk of Febrile Seizures.
6/29/2010. According to a clinical trial that assessed Vaccine Safety Datalink data collected over 8 years, seizure and fever risk in 12- to 23-month-olds is increased after administration of the combination measles-mumps-rubella-varicella (MMRV) vaccine as compared with separate measles-mumps-rubella (MMR) and varicella vaccines (relative risk: 1.98 [95% CI: 1.43–2.73]). It was determined that the MMRV vaccination results in 1 additional seizure for every 2300 doses given instead of separate MMR and varicella vaccines, and parents should therefore be informed of the increased risk when considering the vaccine for their infants.
Source: AAP
Vaccinia Virus Infection Resulting from Contact with Smallpox Vaccinee.
7/02/2010. The CDC reminds healthcare providers caring for U.S. military personnel and their contacts to consider vaccinia virus in diagnoses due to the reinstatement of routine smallpox vaccination of service members in 2002. Several cases of transmission of vaccinia virus have been reported in the past 12 months from sexual contact with a smallpox vaccinee, but are also common from any contact of the face, nose, mouth, lips, genitalia, anus, and eye with the inoculation site within 2-3 weeks of administration. Vaccinees should be educated about transmission and autoinoculation prevention methods such as frequent hand washing, covering vaccination site with bandage, and not sharing linens or clothing with unvaccinated persons.
Source: CDC
Hepatitis A Vaccination Encouraged.
7/02/2010. Records from Immunization Information System sentinel sites show that there was a significant improvement in Hepatitis A vaccination coverage from 17% in 2006 to 47% in 2009, but that it has now plateaued. Due to the historic low of Hepatitis A incidence reached in 2007, which is attributed to this increase in coverage, the CDC is encouraging Hepatitis A vaccination of all children beginning at the age of 12 months.
Source: CDC
Pentavalent Rotavirus Vaccine (RV5) Associated with Reduction in Gastroenteritis.
6/29/2010. Surveillance of 16,000 children under the age of 5 years, in a pediatric practice in New Orleans, beginning in 2004, revealed that an increase in the use of RV5 (from 11.1% to 45.6%) was associated with a 67% decease in RV-positive acute gastroenteritis (AGE) emergency department visits & hospitalizations and a 50% decrease in all-cause AGE hospitalizations. The reduction was seen among children targeted for immunization as well as older groups, suggesting a herd-immunity effect.
Source: AAP
Vaccination-Induced HIV Seropositivity/Reactivity.
7/21/2010. Background: HIV vaccination can cause a reactive result in HIV testing in the absence of infection known as vaccine-induced seropositivity/reactivity (VISP).
Methods: HIV-seronegative adults who completed phase 1 and phase 2a vaccine trials were evaluated using 3 common FDA approved enzyme immunoassay (EIA) HIV antibody kits to determine the frequency of VISP occurrence.
Results: 908 of 2176 participants had VISP (41.7%; 95% CI, 39.6%-43.8%). 399 of 460 (86.7%; 95% CI, 83.3%-89.7%) adenovirus 5 product recipients, 295 of 552 (53.4%; 95% CI, 49.2%-57.7%) recipients of poxvirus alone or as a boost, and 35 of 555 (6.3%; 95% CI, 4.4%-8.7%) of DNA-alone product recipients developed VISP. The types EIA assays used presented varying results, however, all recipients of a glycoprotein 140 vaccine (n = 70) had VISP, with 94.3% testing reactive with all 3 EIA kits tested.
Author’s Conclusion: The induction of VISP is very common; development and detection appear to be associated with the immunogenicity of the vaccine and the EIA assay used.
Source: JAMA
Need for Better Pneumococcal Vaccines. 7/01/2010. Background: There is a debate surrounding the efficacy of the 23-valent pneumococcal polysaccharide vaccine (PPV) and whether it reduces mortality and hospitalization for vaccine-preventable infections following community-acquired pneumonia (CAP). Methods: A population-based cohort study in Canada followed 2,950 hospitalized CAP patients and their post discharge outcomes for 5 years. Results: 48% of the patients died after discharge and 17% were readmitted with vaccine-preventable infections. Overall, 55%, or 1,626 of the 2,950 patients, reached the composite outcome of death or infection. Conclusions: PPV was not associated with a reduced mortality or hospitalization rate, and half of patients discharged from the hospital after pneumonia die or are readmitted with a vaccine-preventable infection within 5 years. Source: CID
TLR9 Agonist to 7vPnC Increases Efficacy in HIV Patients. 7/01/2010. Background: HIV patients are typically under responsive to immunization, and this trial tested whether adding CPG 7909, a toll like receptor 9 (TLR9) agonist and vaccine adjuvant, to 7 valent pneumococcal conjugate vaccine (7vPnC) would increase its efficacy in these individuals. Methods: This was a double blind, placebo controlled, phase 1b/2a study in which 7vPnC (Prevnar) and 23 valent pneumococcal polysaccharide vaccine (PPV23; Pneumo Novum) doses were combined with either 1 mg of CPG 7909 or a phosphate buffered saline and randomly assigned and administered to 97 HIV positive adults. Results: The proportion of high responders at the end of the experiment were 48.8% and 25% for the CPG 7909 and phosphate buffered saline groups respectively. Mild systemic and injection site reactions to the 7vPnC were more common in the CPG 7909 group, but no adverse effects on CD4+ cell count or organ functions occurred. Conclusions: The addition of CPG 7909 to the 7vPnC greatly increased the vaccination's efficacy in HIV-infected adults. Source: CID
June 2010
Rotavirus Vaccine Contraindicated in Infants with SCID. 6/11/2010. Merck & Co. and GlaxoSmithKline Biologicals have both revised the prescribing information and patient labeling for their rotavirus vaccine products with approval from the FDA due to the eight reported cases of vaccine-acquired rotavirus infection in severe combined immunodeficiency (SCID) patients since the vaccination's introduction to the United States in 2006. The rotavirus vaccine (both RV1 and RV5) is now contraindicated in infants diagnosed with SCID. Source: CDC
May 2010
Human Papillomavirus Vaccine Guidance. 5/28/2010. The FDA approved the use of HPV2 (Cervarix) in females 10 to 25 years of age and HPV4 (Gardasil) in males and females 9 to 26 years of age. The Advisory Committee on Immunization Practices (ACIP) recommends routine and catch-up vaccinations for females only; the use of HPV4 in males to prevent the risk of acquiring genital warts is approved, however, routine use is not recommended. Source: CDC
ACIP Recommendations: Use of MMRV Vaccine. 05/07/2010. Since July 2007, supplies of combination measles, mumps, rubella, and varicella vaccine (MMRV, ProQuad) vaccine have been temporarily unavailable as a result of manufacturing constraints unrelated to efficacy or safety (i.e., lower-than-expected yields of bulk varicella-zoster virus in production lots). MMRV vaccine is expected to be available again in the United States in May 2010. ACIP recommendations for use of MMRV vaccine have been summarized. The routinely recommended ages for measles, mumps, rubella, and varicella vaccination continue to be 12--15 months for the first dose and 4--6 years for the second dose. MMRV vaccine may be administered simultaneously with other vaccines recommended for children aged 12--15 months and 4--6 years. If simultaneous administration is not possible, MMRV vaccine may be administered at any time before or after an inactivated vaccine but at least 28 days before or after another live, attenuated vaccine, except varicella vaccine, for which a minimum interval of 3 months is recommended. Source: CDC
April 2010
Vaccination Statistics in Health-care Providers (HCP) for Seasonal Flu and Influenza A H1N1: 04/02/2010: The CDC MMWR released an update to vaccination rates up until January 2010. Seasonal influenza vaccine became available in August 2009, and 2009 H1N1 vaccine became available in October. By mid-January 2010, an estimated 61.9% of HCP had received a seasonal influenza vaccination and an estimated 37.1% of HCP had received a 2009 H1N1 vaccination. Seasonal influenza vaccination coverage was substantially higher among HCP working in hospitals (71.7%) than those working in long-term care facilities (54.0%) or other settings (48.4%) (p = 0.003 and p = 0.001, respectively). 2009 H1N1 vaccination coverage also was higher among HCP working in hospitals (50.6%) than those working in outpatient clinics (39.2%), long-term care facilities (20.1%), or other settings (33.4%) (p = 0.003, p<0.001, and p = 0.015, respectively). HCP working in intensive-care, burn, or obstetric units, or around seriously ill patients were more likely to be vaccinated than other HCP for both seasonal influenza (70.2% versus 59.0%; p = 0.026) and 2009 H1N1 (48.2% versus 33.4%; p = 0.003). HCP with a bachelor's degree or higher were more likely to be vaccinated for 2009 H1N1 compared with HCP with a high school diploma or less (41.9% versus 27.6%; p = 0.014). Educational status was not associated with receipt of seasonal influenza vaccination, nor was sex, age, or race associated with coverage of either vaccine type. HCP were more likely to believe seasonal influenza vaccination was safe compared with 2009 H1N1 vaccination (80.9% versus 66.6%; p<0.001). Although HCP considered both vaccines to be protective, more HCP believed seasonal influenza vaccination was worth the time and expense (74.2%) than did those who believed 2009 H1N1 vaccination was worth the time and expense (62.8%; p<0.001). Source: CDC
March 2010
Rotarix Vaccine Suspended Due to Presence of Porcine Circovirus Type 1 Presence: 03/22/2010. The FDA is recommending that healthcare professionals temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus disease. FDA's recommendation is a precaution taken while the agency learns more about the situation. Source: FDA MedWatch
New 13-Valent Pneumococcal Conjugate Vaccine May Protect Against Invasive Pneumococcal Disease. 03/12/2010. Invasive pneumococcal disease (IPD) is known to be caused by Streptococcus pneumoniae (pneumococcus) and is still the leading cause of serious illness in children and adults. In February 2010, the Advisory Committee on Immunization Practices (ACIP) provided recommendations for use of a newly licensed 13-valent pneumococcal conjugate vaccine (PCV13). PCV13 contains the seven serotypes in PCV7 (4, 6B, 9V, 14, 18C, 19F, and 23F) and six additional serotypes (1, 3, 5, 6A, 7F, and 19A). This recommendation came after noticing that routine infant immunization with PCV7, there was noticeable increase in IPD from non-PCV7 serotypes, predominantly serotype 19A. As such, the ACIP now recommends the use of PCV13 in the routine immunization schedule since has the potential to further reduce IPD caused by the six additional serotypes (1, 3, 5, 6A, 7F, or 19A) among children aged <5 years. In addition, based on available safety, immunogenicity and disease burden data, the ACIP also recommends that a single supplemental PCV13 dose be given to healthy children aged 14--59 months and to children with underlying medical conditions up to age 71 months who already have completed a schedule of PCV7. Source: CDC
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