Pharmacology Weekly

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News and Updates to Vaccines & Immunizations


January 2012

Measles Outbreak in 2009. 1/20/2012. The CDC is reporting on a measles outbreak that began with transmission in a healthcare setting and are reminding reminding healthcare workers of this potential. On March 10, 2009 an unvaccinated child who arrived recently from India was brought to an emergency department in Pennsylvania was treated for viral exanthema and discharged. This child was later diagnosed with measles as were five other patients who also visited the same ED the same day. Although endemic measles transmission has been interrupted in the United States, importations of this highly infectious virus continue, and the CDC is reminding healthcare workers of the potential for measles transmission in health-care settings. To decrease transmission, clinicians should know the signs and symptoms of measles, request travel histories of patients suspected of any infectious disease, and isolate potentially infectious patients. Hospital employees should have documented immunity to measles, and employees without evidence of measles immunity should be offered vaccination in accordance with Advisory Committee on Immunization Practices (ACIP) and Hospital Infection Control Practices Advisory Committee (HICPAC) recommendations. Source: CDC


A(H1N1)pdm09 Vaccine in Jails and Prisons. 1/06/2012. The Emory University Preparedness and Emergency Response Research Center, aided by the National Commission on Correctional Health Care (NCCHC), conducted a survey to document whether jails and prisons received A(H1N1)pdm09 vaccine during the 2009-10 pandemic period and found that 55% of jails did not receive A(H1N1)pdm09 vaccine during the pandemic period, whereas only 14% of federal prisons and 11% of state prisons did not receive the vaccine. Greater inclusion of correctional facilities, especially smaller facilities, in pandemic preparedness planning might better protect correctional facility populations and the community as a whole in the event of future influenza pandemics. Source: CDC




November 2011

Expanded Indication for Herpes Zoster Vaccine. 11/11/2011. The FDA has approved an expanded indication of the use of Herpes zoster vaccine (Zostavax, Merck & Co., Inc.) to include people aged 50-59 years. The ACIP however declined to recommend its use in this population, and continues to recommend the use of Zostavax in people 60 years and older. Source: CDC




October 2011

FDA Communication on Use of Jet Injectors with Inactivated Influenza Vaccines. 10/26/2011. In response to recent questions, the FDA is clarifying that influenza vaccinations are not labeled or approved for administration by jet injector. Currently, there is only one vaccine, Measles, Mumps and Rubella (MMR), that is approved and specifically labeled for administration by jet injector. Inactivated influenza vaccines labeled for IM injection are intended for administration using a sterile needle and syringe and one inactivated influenza vaccine labeled for ID administration is supplied in its own pre-filled syringe. The live attenuated influenza vaccine is given in the nose through a sprayer, which is not a jet injector. Source: FDA


HPV Vaccination Recommended for Boys. 10/26/2011. The Advisory Committee on Immunization Practices has recommended that boys and young men aged 11-26 years be vaccinated against HPV, because vaccination participation in girls is still fairly low. There are hopes that these recommendations will encourage insurance companies to pay for the vaccination. Source: AMA


History of Intussusception Added as a Contraindication for Rotavirus Vaccination. 10/21/2011. The FDA has approved revised prescribing information and patient labeling for the monovalent rotavirus vaccine to include history of intussusception as a contraindication. Rotavirus vaccination is now contraindicated for infants with a history of severe allergic reaction after a previous dose of rotavirus vaccine or exposure to a vaccine component, infants diagnosed with severe combined immunodeficiency, and infants with a history of intussusception. Source: CDC


Updated Recommendations for Use of Tdap Vaccine in Pregnant Women and Persons in Close Contact with an Infant. 10/21/2011. ACIP made recommendations for use of Tdap in unvaccinated pregnant women and updated recommendations on cocooning and special situations in order to reduce the burden of pertussis in infants. For complete updated recommendations see: CDC


Recommendations for Use of Quadrivalent Meningococcal Conjugate Vaccine (MenACWY-D) Among Children Aged 9 Through 23 Months at Increased Risk for Invasive Meningococcal Disease. 10/14/2011. The FDA approved the use of a quadrivalent meningococcal conjugate vaccine (MenACWY-D) (Menactra, Sanofi Pasteur) as a 2-dose primary series among children aged 9 through 23 months. Vaccination with meningococcal polysaccharide vaccine (MPSV4) is not recommended for children aged under 2 years because of low immunogenicity and short duration of protection in this age group. ACIP recommended that children aged 9 through 23 months with certain risk factors for meningococcal disease including children who have persistent complement component deficiencies, who are traveling to or residents of countries where meningococcal disease is hyperendemic or epidemic, and who are in a defined risk group during a community or institutional meningococcal outbreak, receive a 2-dose series of MenACWY-D, 3 months apart. Because of their high risk for invasive pneumococcal disease, children with functional or anatomic asplenia should be vaccinated with MenACWY-D beginning at age 2 years to avoid interference with the immunologic response to the infant series of PCV. If children older than 2 years with functional or anatomic asplenia have not yet received all recommended doses of PCV, they should receive all recommended doses separated from MenACWY-D by at least 4 weeks. Source: CDC




September 2011

Expanded Age Indication for a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine. 9/14/2011. On July 8, 2011, the FDA expanded the age indication for the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) Boostrix to include persons aged 10 years and older. SourceFDA




August 2011

Adolescent Vaccination Coverage Report. 8/26/2011. The ACIP recommends that adolescents routinely receive meningococcal conjugate (MenACWY, 2 doses), tetanus, diphtheria, acellular pertussis (Tdap, 1 dose), and human papillomavirus (HPV, 3 doses) vaccines, and the CDC analyzed National Immunization Survey data to track vaccination coverage among adolescents 13 through 17 years of age. The analysis found that coverage increased for all three vaccines: Tdap from 55.6% to 68.7%, MenACWY from 53.6% to 62.7%, one dose or greater of HPV from 44.3% to 48.7%, and three doses or greater of HPV from 26.7% to 32.0%. Source: CDC


Influenza Vaccination Recommendations. 8/26/2011. The ACIP continues to recommend routine annual influenza vaccination for all persons aged 6 months or older. To permit time for production of protective antibody levels, vaccination should optimally occur before onset of influenza activity in the community. Children aged 6 months through 8 years require 2 doses of influenza vaccine administered a minimum of 4 weeks apart during their first season of vaccination to optimize immune response. A prior severe allergic reaction to influenza vaccine, regardless of the component suspected to be responsible for the reaction, is a contraindication to receipt of influenza vaccine. SourceCDC


Influenza Vaccination Coverage Among Pregnant Women. 8/19/2011. Estimated influenza vaccination coverage among pregnant women increased from 15% to nearly 50% in response to the 2009 influenza A (H1N1) pandemic. To estimate influenza vaccination coverage among pregnant women for the 2010-11 season, CDC analyzed data from an internet panel survey conducted in April 2011 among women who were pregnant any time during October 2010-January 2011. Among 1,457 survey respondents, 49% reported that they had received influenza vaccination: 12% were vaccinated before pregnancy, 32% during pregnancy, and 5% after pregnancy. Women offered influenza vaccination by a health-care provider were more likely to be vaccinated (71%) than other women (14%) and were more likely to have positive attitudes about vaccine effectiveness and safety. SourceCDC


Influenza Vaccination Coverage Among Healthcare Personnel. 8/19/2011. The results of an internet-based survey of 1,931 healthcare personnel conducted by the CDC indicated that overall influenza vaccination coverage among personnel was 63.5% during the 2010-11 influenza season. Among healthcare personnel working at a facility where vaccination was required by their employer, 98.1% were vaccinated. Among healthcare personnel without such an employer requirement but who were offered vaccination onsite, 69.9% coverage was associated with a personal reminder from the employer to get vaccinated, 67.9% coverage with vaccination availability at no cost, and 68.8% coverage with vaccination availability for more than one day. SourceCDC


Tdap Vaccination Recommendations for Pregnant Women. 8/5/2011. The ACIP has approved new recommendations for the use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) for pregnant women and persons in contact with infants and special situations. Pregnant women who have not previously received Tdap should be administered Tdap preferably during the third or late second trimester. If not received during pregnancy, Tdap should be administered immediately postpartum. Adolescents and adults who have close contact with an infant younger than 12 months and have not previously received Tdap should receive a single dose at least 2 weeks before close contact with the infant. If a Td booster is indicated for a pregnant woman who has not previously received Tdap, healthcare providers should administer Tdap. Pregnant women who never have been vaccinated against tetanus should receive three vaccinations containing tetanus and reduced diphtheria toxoids during pregnancy. SourceCDC


Meningococcal Disease Vaccination Guidelines. 8/05/2011. The Advisory Committee on Immunization Practices (ACIP) recommends that persons aged 2 through 55 years at increased risk for meningococcal disease and all adolescents aged 11 through 18 years be immunized with meningococcal conjugate vaccine. The two licensed quadrivalent meningococcal conjugate vaccines are MenACWY-CRM (Menveo, Novartis Vaccines and Diagnostics) and MenACWY-D(Menactra, Sanofi Pasteur). ACIP also recommends that all adolescents receive a booster dose of quadrivalent meningococcal conjugate vaccine at age 16 years. Source: CDC




July 2011

Influenza Vaccination of Schoolchildren. 7/15/2011. Background: The purpose of this study was to determine whether the universal influenza vaccination for schoolchildren was effective in controlling influenza outbreaks in a school. Methods: In this retrospective descriptive study Influenza vaccine coverage rates, total numbers of class cancellation days, and absentee rates were reviewed in a single elementary school during a 24-year period from 1984-2007. Results: The mean number of class cancellation days and the mean absentee rate in the compulsory vaccination period (1984-1987; mean vaccine coverage rate, 96.5%) were 1.3 days and 2.5%, respectively; 8.3 days and 3.2% during the quasi-compulsory vaccination period (1988-1994; vaccine coverage, 66.4%), respectively; 20.5 days and 4.3% during the no-vaccination period (1995-1999; vaccine coverage, 2.4%), respectively; and 7.0-9.3 days and 3.8%-3.9% during the voluntary vaccination period (2000-2007; vaccine coverage, 38.9-78.6%), respectively. Author's Conclusion: The universal influenza vaccination for schoolchildren was effective in reducing the number of class cancellation days and absenteeism in the school. Source: CID




May 2011

Meningococcal Vaccine for High-Risk Infants. 6/23/2011. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that children ages 9 to 23 months who are at high risk for meningococcal disease, including those with complement component deficiencies, infants in a defined risk group for a community or institutional outbreak, and those traveling to areas where meningococcal disease is epidemic or highly endemic, should be vaccinated with the quadrivalent meningococcal vaccine. This specific group of high-risk children would be administered vaccine in two doses three months apart. SourceAAP


Japanese Encephalitis Vaccine No Longer Available for Children. 5/27/2011. Inactivated mouse brain-derived Japanese encephalitis (JE) vaccine (JE-MB [manufactured as JE-Vax]), the only JE vaccine that is licensed for use in children in the United States, is no longer available as it is no longer being produced and all remaining doses expired in May 2011. One pediatric dose-ranging study for an inactivated Vero cell culture-derived JE vaccine (JE-VC [manufactured as Ixiaro]) has been completed and 2 safety and immunogenicity studies are ongoing. Currently for pediatric patients determined to be at risk may enroll in the ongoing clinical trial, receive JE-VC off-label, or receive JE vaccine at an international travelers' health clinic in Asia, and should take precautions listed on the CDC's website. Source: CDC


Booster Dose Recommended for Japanese Encephalitis Vaccine. 5/27/2011. New data about the inactivated, Vero cell culture-derived JE vaccine (JE-VC [manufactured as Ixiaro]) regarding the persistence of neutralizing antibodies following primary vaccination and the safety and immunogenicity of a booster dose is available. Based on this new information, the Advisory Committee on Immunization Practices is recommending that if the primary series of JE-VC was administered more than 1 year previously, a booster dose may be given to U.S. travelers and laboratory personnel who are at risk for potential JE virus exposure. Source: CDC


2011 Child and Adolescent Immunization Schedules Updated. 5/19/2011. The CDC's Childhood and Adolescent Immunization Schedule, which applies to children from birth to 18 years of age, has been updated. For the updated schedules, and "catch-up schedules" see: CDC


Potential Safer Alternative to Live Attenuated 17D Vaccine. 5/01/2011. Background: This study evaluated the safety and immunogenicity of XRX-001 purified whole-virus, β-propiolactone-inactivated yellow fever vaccine produced in Vero cell cultures and adsorbed to aluminum hydroxide (alum) adjuvant as an alternative to the highly effective live yellow fever vaccine (17D) which can cause serious adverse events, including viscerotropic disease, which is associated with a high rate of death. Methods: In this double-blind, placebo-controlled, dose-escalation, phase 1 study, 60 healthy subjects between 18 and 49 years received intramuscular injections of vaccine that contained 0.48 μg or 4.8 μg of antigen on two visits 21 days apart. Levels of neutralizing antibodies were measured at baseline and on days 21, 31, and 42. Results: The vaccine induced the development of neutralizing antibodies in 100% of subjects receiving 4.8 μg of antigen in each injection and in 88% of subjects receiving 0.48 μg of antigen in each injection. Adverse events that occurred at a higher incidence in the two vaccine groups than in the placebo group included mild pain, tenderness, and itching at the injection site, as well as one case of urticaria. Author's Conclusion: A two-dose regimen of the XRX-001 vaccine, containing inactivated yellow fever antigen with an alum adjuvant, has the potential to be a safer alternative to live attenuated 17D vaccine. SourceNEJM




April 2011

Menactra Approved for use in Children as Young as 9 Months. 4/22/2011. The FDA has approved the use of Menactra in children as young as 9 months as the first vaccine in toddlers and infants for the prevention of invasive meningococcal disease. Menactra is given as a two-dose series beginning at 9-months, three months apart. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability and fever comparable to other vaccines routinely recommended for young children. Source: FDA


Tdap Recommendations Updated. 4/04/2011. The ACIP approved revised recommendations for healthcare personnel on use of tetanus toxoid, which include that all healthcare personnel should receive a single does of Tdap as soon as feasible and should receive routine booster immunizations against tetanus and diptheria, and that hospitals should provide Tdap for healthcare providers using approaches that maximize vaccination rates. The recommendations on the use of postexposure antimicrobial prophylaxis have also been updated: Healthcare facilities should maximize efforts to prevent transmission of Bordetella pertussis taking respiratory precautions and all healthcare providers who have unprotected exposure to pertussis should receive postexposure antimicrobial prophylaxis if they are likely to expose a patient at risk for severe pertussis or be monitored daily for 21 days after pertussis exposure and treated at the onset of signs and symptoms of pertussis if otherwise. Source: CDC




February 2011

Updated Immunization Schedules. 2/11/2011. The Advisory Committee on Immunization Practices have published this years immunization schedules to reflect current recommendations for the licensed vaccines. Both schedules include several changes and can be viewed at the following. 

Recommended Immunization Schedule for Persons 0-18 Years
Recommended Immunization Schedule for Adults


Updated Recommendations for Use of Meningococcal Conjugate Vaccines. 1/28/2011. The Advisory Committee on Immunization Practices approved updated recommendations for the use of quadrivalent (serogroups A, C, Y, and W-135) meningococcal conjugate vaccines (Menveo, Novartis; and Menactra, Sanofi Pasteur) in adolescents and persons at high risk for meningococcal disease to supplement previous recommendations for meningococcal vaccination. Two new recommendations include routine vaccination of adolescents, preferably at age 11 or 12 years, with a booster dose at age 16 years, and a 2-dose primary series administered 2 months apart for persons aged 2 through 54 years with persistent complement component deficiency (e.g., C5--C9, properidin, factor H, or factor D) and functional or anatomic asplenia, and for adolescents HIV. View Full Report atCDC




January 2011


Diarrhea-Associated Hospitalizations After Rotavirus Vaccine Introduction. 1/01/2011. Background: This study aimed to ascertain whether decreases in severe diarrhea among children were sustained over 2 postvaccine rotavirus seasons. Methods: The number of all-cause diarrhea-related and rotavirus-specific hospitalizations were examined, comparing 3 prevaccine seasons (2003-2006) to 2 postvaccine seasons (2007-2009). Results: The median of all-cause diarrhea-related hospitalizations decreased by 50% (n = 7760) in 2007-2008 and by 29% (n = 11 039) in 2008-2009. Author's Conclusion: ompared with prevaccine seasons, decreases in diarrhea- and rotavirus-associated hospitalizations seen in 2007-2008 were sustained in 2008-2009 but were somewhat smaller. SourceAAP




December 2010

Influenza Vaccine in Pregnant Women Reduces Hospitalization of their Infants Due to Influenza. 12/15/2010. Background: This study assessed the efficacy of a vaccination strategy in which pregnant women receive the influenza vaccination, thus transferring the antibodies to their infants. Methods: In a matched case‐control study, vaccine effectiveness was calculated on the basis of matched odds ratios of a case group, infants under 1 year of age admitted to a large urban hospital in the northeastern United States because of laboratory‐confirmed influenza, and a control group, infants who tested negative for influenza and matched cases by date of birth and date of hospitalization within 4 weeks. Results: The mothers of 2 of 91 case subjects and 31 of 156 control subjects younger than 6 months, and 1 of 22 case subjects and 2 of 36 control subjects aged 6 months, had received influenza vaccine during pregnancy. The effectiveness of influenza vaccine given to mothers during pregnancy in preventing hospitalization among their infants, adjusted for potential confounders, was 91.5% (95% CI, 61.7%-98.1%; p=0.001) for infants aged younger than 6 months of age. Author's Conclusion: Influenza vaccine given to pregnant women is 91.5% effective in preventing hospitalization of their infants for influenza during the first 6 months of life. SourceCID




October 2010

Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine. 9/03/2010. Background: A Clinical trial was performed to evaluate the immunogenicity and safety of 13-Valent pneumococcal conjugate vaccine (PCV13) as compared with 7-Valent pneumococcal conjugate vaccine (PCV7). Methods: Infants were assigned to receive routine vaccinations of either PCV7 or PCV13 and then assessed to evaluate pneumococcal anticapsular polysaccharide-binding immunoglobulin G responses and functional antipneumococcal opsonophagocytic activity. Results: PCV13-elicited immunoglobulin G titers and functional opsonophagocytic activity were comparable to those of PCV7 for the 7 common stereotypes and greater for the 6 additional stereotypes. Author's Conclusion: PCV13 will be as effective as PCV7 in the prevention of pneumococcal disease caused by the 7 common stereotypes, and may extend protection against the 6 additional stereotypes. Source: AAP




September 2010

Vaccination Coverage Among Children 19 to 35 Months. 9/17/2010. The National Immunization Survey (NIS) published a report evaluating the 2009 coverage estimates for children aged 19 to 35 months. The report focuses on more recently recommended vaccines and indicates that the percentage of children in the United States who have not received any vaccines remains less than 1%. Source:CDC


Updated Recommendation for Prevention of Invasive Pneumococcal Disease. 9/03/2010. The Advisory Committee on Immunization Practices (ACIP) published updated recommendations to prevent invasive disease from Streptococcus pneumoniae (pneumococcus) through the use of the 23-valent pneumococcal polysaccharide vaccine (PPSV23) among all adults over 65 years of age, and all adults at greater risk for serious pneumococcal infection. The updates changed the recommendations to include smoking and asthma in the indications for which PPSV23 vaccination is recommended, and no longer recommend routine use of PPSV23 for Alaska Natives or American Indians younger than 65 years unless they have medical or other indications for PPSV23. Source:CDC


Changes in Measurement of Haemophilus influenzae serotype b (Hib) Vaccination Coverage. 8/27/2010. The National Immunization Survey (NIS) introduced a new method for measuring Haemophilus influenzae serotype b (Hib) vaccination coverage distinguishing between having a primary series completed and being fully vaccinated (primary series completed plus booster dose). This revision was made in light of the findings that some product types require 4 doses to be fully vaccinated. As determined by this new method 56.9% of children in the United States aged 19-35 months are fully vaccinated. Source: CDC


Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine. 8/23/2010.Background: This trial was designed to assess the safety and efficacy of the 13-Valent pneumococcal conjugate vaccine (PCV13) as compared to the 7-Valent pneumococcal conjugate vaccine (PCV7). Methods: Infants received PCV13 or PCV7 at ages 2, 4, 6, and 12 to 15 months with routine pediatric vaccinations. Pneumococcal anticapsular polysaccharide-binding immunoglobulin G responses and functional antipneumococcal opsonophagocytic activity were assessed 1 month after dose 3, before the toddler dose, and 1 month after the toddler dose. Results: For the 7 common serotypes, PCV13 elicited immunoglobulin G titers and functional opsonophagocytic activity, which were not inferior to those elicited by PCV7. Author's Conclusion: PCV13 will be as effective as PCV7 in the prevention of pneumococcal disease caused by the 7 common serotypes. Source:AAP



August 2010

Vaccination Coverage Among Adolescents. 8/20/2010. The CDC provides a general summary of its National Immunization Survey-Teen (NIS-Teen) results regarding national, state, and local area vaccination coverage among adolescents between 13 and 17 years of age. Based on these results, the Advisory Committee for Immunization Practices (ACIP) recommends that adolescents routinely receive the meningococcal conjugate (MenACWY), tetanus, diphtheria, and acellular pertussis (Tdap), and human papillomavirus (HPV) (for females) vaccinations. The measles, mumps, and rubella (MMR), hepatitis B (HepB), and varicella (VAR) vaccinations should also be administered to adolscents who missed them during childhood. Source: CDC


Influenza Vaccine Recommendations. 8/06/2010. The CDC has published updates to the Influenza vaccine recommendations. Key updates: 1) annual vaccination should be administered to all persons aged 6 months and older; 2) children aged 6 months to 8 years whose vaccination status is unknown, who have never received seasonal influenza vaccine, or who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine should receive 2 doses of a 2010-11 seasonal influenza; 3) vaccines containing the 2010-11 trivalent vaccine virus strains A/California/7/2009 (H1N1)-like (the same strain as was used for 2009 H1N1 monovalent vaccines), A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens should be used; 4) information about Fluzone High-Dose, a newly approved vaccine for persons aged ≥65 years; and 5) information about other standard-dose newly approved influenza vaccines and previously approved vaccines with expanded age indications. Source: CDC


Hepatitis B Vaccination Proposed for All Diabetic Adults. 7/30/2010. In response to new, unpublished data revealing a higher risk for hepatitis B contraction in diabetic adults, an advisory group at the CDC proposes that all adults with diabetes be vaccinated. A vaccination program including better labeling, cleaning, and design of blood glucose monitoring devices, is also being recommended because of a suggested correlation between hepatitis B outbreaks and glucose meter practices. Source: Family Practice News


Yellow Fever Vaccine Recommendations. 7/30/2010. The CDC has published updates to the yellow fever vaccine recommendations, which were last published in 2002. Yellow fever is endemic to sub-Saharan Africa and tropical South America, has no known treatment, and is fatal in 20-50% of persons with severe disease. All travelers to such countries should be advised of the risks and prevention methods; vaccination of these travelers 9 months and older is recommended. Source: CDC


Emphasis to Continue Polio Vaccinations. 7/15/2010. Polio immunization rates in many areas of the United States have fallen below the WHO's recommended 90%. In light of this and a recent polio outbreak in Tajikistan, which, like the US, is a certified polio-free country, the American Academy of Pediatrics is emphasizing the need to ensure that patients are fully vaccinated against polio. Source: AAP


Henoch-Schönlein Purpura (HSP) Not Associated with Meningococcal Polysaccharide Vaccine for Ages 16-20 Years. 7/12/2010. Background: Periodic case reports link Henoch-Schönlein purpura (HSP) to vaccine administration. This study assessed the potential risk of HSP associated with the meningococcal polysaccharide vaccine Methods: Vaccine Safety Datalink (VSD) data was gathered for all subjects between 16 and 20 years who received a meningococcal polysaccharide vaccine and were followed for evidence of HSP for the 42 days after vaccination. Results: No cases of HSP were found. Author's Conclusion: This data shows no relation between the meningococcal polysaccharide vaccine and HSP in persons aged 16-20 years. Source: AAP



 

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 


GBS and the 2009 H1N1 Vaccine.
6/02/2010. Guillain-Barré syndrome (GBS), a peripheral neuropathy that causes paralysis and, sometimes in severe cases, respiratory failure and death, can, very rarely, follow vaccination. Because of the associated increased risk for GBS with the H1N1 vaccine in 1976, the CDC's Emerging Infections Program (EIP) and several other federal surveillance systems are monitoring the risk for GBS after the 2009 H1N1 vaccination. EIP has covered approximately 45 million residents in 10 specifically defined catchment areas of the United States and preliminary findings showed a GBS incidence of 1.92 per 100,000 person-years among vaccinated persons and 1.21 per 100,000 person-years among unvaccinated persons. If end-of surveillance analysis confirms these findings, the GBS risk and safety profile will be similar to those of the seasonal influenza vaccines, which have an excellent safety record. 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




February 2010

New Adult Immunization Scheduler Available from the CDC.  02/15/2010.  The CDC has released this service which is based on the 2010 Recommended Adult Immunization Schedule as recommended by the Advisory Committee on Immunization Practices (ACIP), and the American Academy of Family Physicians (AAFP), the American College of Obstetricians and Gynecologists, and the American College of Physicians. The scheduler provides generally recommended dates for immunizations based on your birth date.  Source: CDC


Lancet Retracts Link of MMR Vaccine to Autism. 02/03/2010. Lancet announced its full retraction of a 1998 research paper by Dr. Andrew Wakefield linking the measles, mumps, and rubella (MMR) vaccine to autism, just days after the U.K. General Medical Council said Wakefield breached his professional duties by making false claims. Furthermore, the fact that the ethics committee of London's Royal Free Hospital had deemed Wakefield's studies of children at the hospital "appropriate" is being considered for investigation. The original research paper noted that parents "associated" behavior symptoms exhibited by their children with the MMR vaccine, sparking numerous letters and a partial retraction by even some of the study's own co-authors. Source: The TimesOnline


New Malaria Vaccine May Be Effective in Children.  02/03/2010.  In a write by Julie Steenhuysen of Reuters a new malaria vaccine created by the Walter Reed Army Institute of Research may be effective in young children. The blood stage vaccine uses the same adjuvant as GlaxoSmithKline's experimental Mosquirix vaccine and targets the malaria parasite after it has passed from the bloodstream into the liver.  The study, which was published in PLoS ONE, included 100 children (aged 1-6 years) in West Africa, showed antibody levels after vaccination increasing to the same level or above that of adults in their communities who have been exposed to malaria their entire lives.  The researchers believe the adjuvant is responsible for the dramatic immune response, and therefore a second test on 400 children is being started.  Sources:  Reuters




January 2010

2010 Child and Adolescent Immunization Schedules Now Available. 
01/07/2010.  The CDC released the 2010 immunization schedule for persons 0-6 years, 7-18 years, and catch up schedule.  SourceCDC


CDC NetConference: What's New on the Child and Adolescent Immunization Schedules.  01/28/2010:  Dr. William Atkinson and Dr. Friedman from the CDC will be leading a teleconference with online visual content.  Course length is 1 hour.  Source: CDC





December 2009


Yellow Fever Vaccine.  12/09/2009:  The CDC released the provisional recommendations from the ACIP today that not only reinforces the need to implement personal protective measures in travelers going to areas where yellow fever transmission is greater (such as South America and Africa) and that the adverse events associated with vaccine should be weighed against the need for vaccine and liklihood of contracting the disease, but also added new precautions and contraindications in receiving the vaccine.  The precautions are in adults ≥60 years of age because of an increased risk for serious adverse events.  The new contraindications for receiving the vaccine are in persons whose immunologic response is either suppressed or modulated by current radiation or recent radiation therapy or drugs and in persons with thymus disorders that are associated with abnormal immune cell function, such as thymomas.  Source: CDC



Influenza A (H1N1) 2009 Monovalent Vaccine.  12/04/2009:  The CDC provided an update regarding the safety of the vaccine since its approval by the FDA on September 15, 2009.  Data from October 1 - November 24, 2009 from the U.S. Vaccine Adverse Event Reporting System (VAERS) and electronic data from 438,376 persons vaccinated in managed-care organizations in the Vaccine Safety Datalink (VSD) indicated 82 adverse event reports per 1 million H1N1 vaccine doses given as compared to 47 reports per 1 million seasonal influenza vaccine doses.  In addition, there were no differences in the proportion of serious adverse events reported between the H1N1 vaccine and the seasonal flu vaccine.  While there are no major signals for unusual adverse events at this time, it is also important to note that this data is limited by the voluntary nature of reporting, VAERS only reports preliminary diagnosis, and the number of doses given in the managed care databases are not sufficient to reveal any rare problems.  Regardless, the majority of current adverse events appear to be mild and similar to those seen with the regular seasonal flu vaccines.  Source: CDC


Announcement: Clinical Vaccinology Course March 12-14, 2010.
  The CDC is putting this conference on to focus on new developments and concerns related to the use of vaccines in pediatric, adolescent, and adult populations.  It is designed for all healthcare professionals with an interest in the clinical use of vaccines.  Source: CDC


HPV Vaccine - Provisional Recommendations Includes Males.  12/01/2009:  The CDC made available the ACIP provisional recommendations on the use of the bivalent HPV (types 16, 18) vaccine (Cervarix) and quadrivalent HPV (types 6, 11, 16, 18) vaccine (Gardasil) for females and males.  As it relates to males, the 3-dose series may be given to males aged 9 - 26 years to reduce their liklihood of acquiring genital warts.  The schedule of shots should include the first being given after age 9, the second shot being 1-2 months after the first shot and the third (final) shot being 6 months after the first shot.  The minimum interval between shots #1 and #2 is 4 weeks and the minimum between shots #2 and #3 is 12 weeks.  If the schedule of shots is interrupted it is not necessary to restart the series.  Comment:  While this vaccine has historically been for females in the hopes of reducing the risk of cervical cancer, HPV can be spread by males who can also develop long-term problems from the HPV infection (although less common than compared to females).  Source: CDC


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