FDA announces resumption of Rotarix use - On June 1, 2010, the Food and Drug Administration (FDA) determined it is appropriate for clinicians and health-care professionals to resume the use of Rotarix and to continue the use of RotaTeq. The FDA also recommends that physicians and public health professionals inform parents of the findings of PCV (porcine circovirus) DNA or PCV in both rotavirus vaccines, and that there is no evidence that these findings pose a safety risk in humans. Both the prescribing information and patient labeling will be revised to include this information. The Vaccine Information Statement (VIS) for rotavirus vaccine has also been updated (effective 5-14-2010), to access the VIS click here. The benefits of vaccination against rotavirus disease are substantial, and far outweigh any theoretical risk posed by PCV types 1 and 2. If you have questions, please contact the Ohio Department of Health at (800) 282-0546 or (614) 466-4643.
CDC - Vaccines & Immunizations
FDA News Release
Information for Health Care Providers and Public Health Professionals
Statement from GlaxoSmithKline
Menveo Meningococcal Conjugate Vaccine approved by FDA – On February 19, the FDA approved Novartis's license application for Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine. Trade named Menveo, the vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. It is approved for use in people ages 11 through 55 years. To read the approval letter, go to: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201343.htm
To read the package insert, go to: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM201349.pdf
Prevnar 13 approved - The U.S. Food and Drug Administration granted approval on March 17 for Pfizer's Prevnar 13™, an expanded version of a vaccine to protect children against more forms of bacterial infections that can cause meningitis, pneumonia and other diseases. Prevnar 13 was approved for the vaccination of children aged 6 weeks through 5 years to protect against 13 varieties of the Streptococcus pneumoniae bacteria, which can cause such serious illnesses as sepsis, infections of the blood, meningitis and pneumonia. The vaccine will essentially replace the original Prevnar vaccine, which only protected against seven types of the bacteria. The CDC's Advisory Committee on Immunization Practices (ACIP) recommended the use of Prevnar 13 for healthy children between the ages of 2 and 59 months. ACIP also recommended that children who have started their immunization series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.
Study linking autism and MMR vaccine retracted
Twelve years after Dr. Andrew Wakefield published his research in The Lancet, an international medical journal, claiming that the measles-mumps-rubella (MMR) vaccine causes autism, the journal formally retracted his paper yesterday (Feb. 2, 2010). The U.K. General Medical Council's Fitness to Practice Panel concluded that Dr. Wakefield provided false information in the report and acted with "callous disregard" for the children in the study. The council is considering if Dr. Wakefield is guilty of serious professional misconduct. A positive finding could cause him to lose his medical practice. Full story.
Parent Brochure Available from CDC on Seasonal and H1N1 Flu
A brochure for parents titled, Seasonal and 2009 H1N1 Flu: For Parents Who Have Children or Adolescents with High-Risk Medical Conditions is now available from the Centers for Disease Control and Prevention. The brochure provides specific information regarding what children are considered to be at risk.
Pediatricians answer your questions
Parents who are doing their homework on their child's vaccines can go directly to the experts for answers - without leaving home. The American Academy of Pediatrics (AAP) offers a new series of audio interviews with pediatricians, researchers, advocates and other parents. Click here to view the interviews.
Speaking out for vaccines
Actress and new mom, Amanda Peet, urges parents to get the facts about immunizations. Click here to view her video and learn more.
OTIS
For a free copy of Ohio's Timely Immunization Schedule click here.