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Deformational Plagiocephaly Not Tied to Frequent OM

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Deformational Plagiocephaly Not Tied to Frequent OM 14 INFECTIOUS DISEASES DECEMBER 2009 • PEDIATRIC NEWS Vaccine Combinations Appear Safe, Effective BY MITCHEL L. ZOLER now provides, said Cosette M. Wheeler, searchers randomized the participants to cidence rates for solicited local reactions— Ph.D., professor of pathology and ob- one of six different treatment schemes: pain, redness, or swelling, and similar so- P HILADELPHIA — Administering two stetrics and gynecology at the University HPV vaccine only at months 0, 1, and 6; licited rates of system reactions, including or more vaccines simultaneously was of New Mexico in Albuquerque. HPV with Tdap at month 0 followed by headache, fatigue, and myalgia. safe and immunogenic in results from All three vaccines are recommended HPV only at months 1 and 6; HPV with The second study examined concomi- two separate studies reported at the an- for administration to adolescent girls, and the meningococcal vaccine at month 0 fol- tant administration of an investigational, nual meeting of the Infectious Diseases bundling them together at one time would lowed by HPV only at months 1 and 6; all 13-valent, conjugated pneumococcal vac- Society of America. potentially increase compliance, Dr. three vaccines at month 0 followed by cine and the trivalent, seasonal influenza One study assessed the immune re- Wheeler said in an interview (although HPV only at months 1 and 6; Tdap only vaccine of 2007-2008 in 1,106 healthy sponse when healthy girls received con- the HPV vaccine at month 0 fol- adults aged 50-59 years. The pneumo- comitant vaccination with a human papil- requires three The results from combined lowed by HPV coccal vaccine is similar to a 7-valent lomavirus (HPV) vaccine along with a doses adminis- only at months 1, vaccine that already has U.S. approval for vaccine for tetanus, diphtheria, and per- tered over a 6- administration of the HPV, Tdap, 2, and 7; and use in infants and children, Prevnar, with tussis (Tdap), and a third vaccine with a month period). and meningococcal vaccines MCV4 only at added antigens so that the vaccine pro- quadrivalent, conjugated meningococcal Her study month 0 and tects against strains that commonly cause formulation (MCV4). The second study used the Cervar- are especially relevant to then HPV only community-acquired pneumonia, said tested coadministration of the 2007-2008 ix formulation of practice because all three are at months 1, 2, Dr. Robert W. Frenck Jr., of Cincinnati seasonal influenza vaccine with an investi- HPV vaccine, and 7. Children’s Hospital Medical Center. gational, 13-valent, conjugated pneumo- the Boostrix for- already approved for U.S. use. The results The pneumococcal vaccine was de- coccal vaccine in adults aged 50-59 years. mulation of showed that 1 veloped by Wyeth (which recently was The results from combined adminis- Tdap, and the Menactra formulation of month after the subjects received any of acquired by Pfizer Inc.), which funded tration of the HPV, Tdap, and meningo- meningococcal vaccine. The Cervarix and the concomitant doses, their immune re- the study. Dr. Frenck had no other dis- coccal vaccines are especially relevant to Boostrix vaccines are marketed by Glaxo- sponses all fell within the prespecified closures for his study. practice because all three are already ap- SmithKline, which funded the study. Men- criteria for noninferiority, compared with One month after vaccination, the im- proved for U.S. use, and the concept of de- actra is marketed by Sanofi Pasteur. Dr. the responses when the vaccines were ad- mune responses to both vaccines in peo- livering all three simultaneously received Wheeler disclosed that in addition to re- ministered individually. Also, the immune ple who received them simultaneously endorsement by the Centers for Disease ceiving research support from Glaxo- responses to the HPV vaccine 6 months fell within the prespecified noninferiori- Control and Prevention’s Advisory Com- SmithKline, she also received funding for after the final dose, when one dose was ty limit, compared with the responses in mittee on Immunization Practices in 2007 studies from Merck, which markets the given in combination with one or two of people who received the two vaccines 1 (MMWR 2007;56:1-24). The only piece HPV vaccine Gardasil, and from Roche the other vaccines, were noninferior to month apart. Simultaneous administra- missing until now was data showing that Molecular Systems. the responses to the HPV vaccine given tion also resulted in similar rates of local the concomitant strategy was safe and im- The study enrolled 1,283 healthy girls by itself. The recipients of two or more and systemic reactions compared with munogenic—something the new study aged 11-18 years at 48 U.S. centers. The re- simultaneous vaccines also had similar in- giving the vaccines 1 month apart. ■ To Date, No Safety Signals of Deformational Plagiocephaly Concern With H1N1 Vaccine Not Tied to Frequent OM BY LEANNE SULLIVAN tional plagiocephaly, the incidence BY MIRIAM E. TUCKER cine and six after inactivated (injected) vaccine. of OM was not higher than that re- The three that have been evaluated so far had hildren with deformational ported by the Centers for Disease B ETHESDA, MD. — Monitoring of in- severe underlying conditions. There have been Cplagiocephaly do not have sig- Control and Prevention for chil- fluenza A(H1N1) vaccine safety in studies 29 reported cases of anaphylaxis, which is nificantly higher rates of otitis me- dren in general. The severity of de- conducted across multiple U.S. government consistent with published estimates following dia, compared with children in the formity showed a nonsignificant agencies have shown no safety signals of con- other vaccinations, he said. general population, according to a correlation with the number of cern so far, nationally or internationally. Two cases of “possible or probable” Guil- recent study. ear infections: Of the 793 patients The multiple data collection efforts—some lain-Barré syndrome have been reported with- Deformational plagiocephaly with the milder plagiocephaly preexisting and others a result of the pan- in 1 day of H1N1 vaccine receipt. The short previously has been reported to be severity levels I-III, 387 (48.8%) had demic H1N1 outbreak—represent “strength- interval “decreases but does not eliminate” the associated with otitis media (OM), had at least one ear infection. Of ened collaboration and communication possibility that H1N1 vaccine caused the event. but this study did not find a sig- the remaining 319 patients with among government agencies and interna- However, to date the rate of reported GBS cas- nificant association. Children in higher severity levels IV-V, 172 tionally, with enhanced capacity for timely sig- es is less than the background rate in the pop- the study with more severe defor- (53.9%) had been diagnosed with nal detection, strengthening, and confirma- ulation, Dr. Izurieta said. mity had a higher rate of ear in- at least one ear infection. The tion,” Dr. Hector Izurieta told the Food and Dr. Claudia Vellozzi of the CDC’s Immu- fection, compared with those with number of ear infections was de- Drug Administration’s Vaccines and Related nization Safety Office described the Vaccine less severe deformity, but this termined by self-reports from pa- Biological Products Advisory Committee. Safety Datalink (VSD), an active surveillance trend also was not significant, tients’ guardians (J. Craniofac. In addition to the FDA, other participating program of both the CDC and managed care wrote Adam Purzycki and his col- Surg. 2009;20:1407-11). agencies include the Centers for Disease Con- plans that cover more than 9.5 million people, leagues at the Wake Forest Uni- A subset of 124 patients were ex- trol and Prevention, the Department of De- or 3.1% of the U.S. population, and is used to versity Medical Center’s North amined by tympanometry to di- fense, the Department of Veterans Affairs, follow up on safety “signals” obtained from Carolina Institute for Cleft and agnose clinical or subclinical OM the Centers for Medicare and Medicaid Ser- VAERS. Craniofacial Deformities, in Win- or fluid collection resulting from vices, and the Indian Health Service, Dr. VSD analyses of pregnant women and of 10 ston-Salem. abnormal drainage, which would Izurieta, chief of the FDA’s analytic epi- GBS cases identified so far have shown no sig- The retrospective study included suggest eustachian tube dysfunc- demiology branch, said in an interview. nificant associations with either H1N1 or sea- 1,112 children with deformational tion. Of these, 121 had readings in- For example, the CDC is currently evalu- sonal vaccine, although it’s still early, she said. plagiocephaly who presented be- dicative of OM. “The significantly ating 205 reports of serious adverse events fol- Dr. Richard Platt of Harvard Pilgrim tween February 2004 and June high percentage of typanogram lowing H1N1 vaccine in the Vaccine Adverse Health Care and Harvard Medical School, 2006. Age at presentation was 3-12 readings that pointed to otitis me- Events Reporting System (VAERS). Of those, Boston, described a new safety analysis that months (mean 5.6 months); 723 dia, whether clinical or subclinical, 70 are among pregnant females. All but 13 his institution will conduct in collaboration were boys and 389 were girls. Of suggests an overall malfunction of were nonserious and none involved maternal with health plans covering approximately 25 this group, 559 (50.3%) were the middle ear drainage function death. million people and nine state immunization reported by their parents as having of the eustachian tube in these Eight deaths following receipt of H1N1 vac- registries comprising a total population of 14 had at least one ear infection, Mr. children,” they wrote. cine have been reported to VAERS, including million; it is called Post-Licensure Rapid Im- Purzycki and his coworkers said.
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