vaccines Tag
10 Jun Pediatric Hospitalizations For Children Dropped Almost 90% After Rotavirus Vaccine Implemented
Posted at 17:38h
in Author Interviews, CDC, Gastrointestinal Disease, JAMA, Pediatrics, Vaccine Studies
MedicalResearch.com Interview with:
Eyal Leshem, MD
Division of Viral Diseases,
US Centers for Disease Control and Prevention,
Atlanta, Georgia
Medical Research: What is the background for this study? What are the main findings?
Response: Routine vaccination of US children to protect against rotavirus began in 2006. The purpose of this study was to examine the effect of implementation of rotavirus vaccine on gastroenteritis and rotavirus hospitalizations of children younger than 5 years old.
The main finding from this study is that hospitalizations for diarrhea in U.S. children younger than 5 years old decreased dramatically during 2008 to 2012 following implementation of routine rotavirus vaccination in 2006. Additionally, seasonal peaks of hospitalizations for rotavirus illness were considerably reduced after the vaccine was implemented compared to years prior to rotavirus vaccination.
By 2012, rates of rotavirus hospitalization declined by approximately 90% across all settings and age groups. Factors such as increasing vaccine coverage as well as herd immunity resulting in less transmission of rotavirus may be responsible for this large decrease.
10 Jun CDC Study Finds No Pattern Suggesting Vaccines Contributed To Or Caused Deaths
MedicalResearch.com Interview with: Dr. Pedro Moro, MD, MPH Immunization Safety Office Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, GA 3033 Medical Research: What is the background for this study? What are the main findings? Response: The Vaccine Adverse Event Reporting System (VAERS) is a US national vaccine safety surveillance system, co-administered by the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA). VAERS accepts reports of adverse events (possible side effects) following vaccination. Anyone can submit a report to VAERS. The study team searched VAERS for US reports of death after any vaccination from 7/1/1997 to 12/31/2013. During that time period, VAERS received 2,149 death reports, with most (68.4%) occurring in children. Among children, the most common causes of death were: o sudden infant death syndrome (44%) o asphyxia, or lack of oxygen to the brain (6%) o septicemia, or blood poisoning from a bacterial infection (5%) o pneumonia (5%) Among adults, the most common causes of death were: o diseases of the circulatory system (47%) o diseases of the respiratory system (15%) o infections and parasitic diseases (12%) o tumors (4%) The main causes of death seen in VAERS reports were consistent with the most common causes of death in the US population. When studied separately, none of these causes of death have found to be related to vaccines. This finding is reassuring, and consistent with previous research on vaccine safety.13 May Study Tests Two Dose Schedule of HPV Vaccination Against Genital Warts In Girls
MedicalResearch.com Interview with:
Maria Blomberg
Virus, Lifestyle & Genes
Danish Cancer Society Research Centre
Copenhagen, Denmark
Medical Research: What is the background for this study? What are the main findings?
Response: Two vaccines against human papillomavirus (HPV) were licensed almost one decade ago. Since then multiple countries have implemented HPV vaccination programs to help reduce genital warts (one of the kinds of warts most harmful to people), but many struggle with low coverage rates. An important barrier to vaccination is the cost of the vaccines and less developed countries also face considerable logistical challenges. Both vaccines were administered as three dose schedules, but in early 2014 the WHO’s Strategic Advisory Group of Experts and the European Medicines Agency reviewed the evidence of reduced dose schedules of HPV vaccination, and subsequently recommended a two dose schedule for young girls. A reduction of the number of doses has obvious advantages; it would lower the costs, ease implementation of vaccination schedules and potentially increase coverage rates. Based on these recommendations, countries around the world have reduced the dosing schedule in their HPV vaccination programs for young girls to two doses. However, the current evidence is based primarily on immunological studies, and because the immune correlate of protection is not known, studies with disease endpoints are very important.
Using the biologically relevant endpoint of genital warts, this study aimed to assess the clinical effectiveness of a two dose schedule of quadrivalent HPV vaccine compared with the standard three-dose regimen administered at month 0, 2 and 6. We found that with the standard vaccination schedule, completion of the three dose regimen is important to gain maximal protection. However, the effectiveness of two doses increased significantly with increasing time between the doses, and with an interval of approximately 6 months between dose one and two, no differences could be found between two and three doses.
07 May Timely Pertussis Vaccination Important For Preventing Infant Deaths
MedicalResearch.com Interview with: Tejpratap S.P. Tiwari, MD Meningitis and Bacterial Vaccine Preventable Diseases Branch Division of Bacterial Diseases National Center for Immunization and Respiratory Diseases Division of Global HIV/AIDS, Center for Global Health Centers for Disease Control and Prevention, Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Tiwari: Infants younger than one year old in the United States are at highest risk for severe outcomes from pertussis and death. The first childhood pertussis vaccine dose is recommended at 2 months old, with additional doses in the first year of life at 4 and 6 months. Studies have established that pertussis vaccines can protect against pertussis disease, complications, and hospitalization in infants when 1 to 3 doses are administered by six months old. This study’s findings suggest that the first pertussis vaccine dose and appropriate antibiotic treatment protect infants against death, hospitalization, and pneumonia. Improved on-time infant vaccination (at 2, 4, and 6 months) could potentially prevent up to 1 out of every 4 infant pertussis deaths.27 Apr HPV Vaccine Still Valuable For Women Who Were Not Fully Vaccinated As Children
MedicalResearch.com Interview with:
Jacqueline Hirth, PhD, MPH
Assistant Professor and
Dr. Abbey B. Berenson MD, MMS, PhD
Center for Interdisciplinary Research in Women's Health
Obstetrics and Gynecology
The University of Texas Medical Branch at Galveston Texas
Medical Research: What is the background for this study? What are the main findings?
Response: In this sample of young women, vaccination was effective at reducing prevalence of vaccine-type HPV (6,11,16,18) compared to women who were unvaccinated. We also found a dose response, with young women who received at least 2 doses of the 3 dose vaccine series having a lower rate of vaccine-type HPV compared to those who only received one dose (8.6% compared to 16.9%, respectively).
25 Apr Malaria Vaccine Has Potential To Contribute To Disease Control
MedicalResearch.com Interview with:
Mary J Hamel, M.D.
Chief, Strategic and Applied Sciences Unit,
And Deputy Branch Chief for Science, CDC Malaria Branch
US Centers for Disease Control and Prevention
1600 Clifton Rd, NE, MS A06
Atlanta GA 30333
Dr. Hamel was principal investigator at the Siaya site in western Kenya.
Medical Research: What is the background for this study? What are the main findings?
Dr. Hamel: Major progress has been made in malaria control during the past decade with the scale up of proven interventions including insecticide treated nets (ITNs), indoor residual spraying, effective diagnosis and treatment for malaria, and intermittent preventive treatment of malaria in pregnancy. Nonetheless, malaria remains a major cause of morbidity and mortality, and a leading cause of pediatric death worldwide. An estimated 198 million cases of malaria and 580,000 deaths occurred in 2013 – most of these in African children.
Now we face additional challenges in malaria control – the emergence of insecticide and drug resistance threatens some of our most effective interventions. New tools are needed to reach the goal of malaria elimination and eventual eradication. Vaccines are some of our most cost-effective interventions, and an effective malaria vaccine would be an important addition to our current malaria control tools.
This week, the RTS,S Clinical Trials Partnership published the final vaccine efficacy and safety results from the RTS,S/AS01 malaria vaccine phase 3 trial in the Lancet (Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial, http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60721-8/abstract). This large randomized controlled double-blind phase 3 clinical trial was conducted in 11 sites in 7 African countries across a range of malaria transmission levels. In all, 15,460 children and young infants were enrolled in two age-categories, those first vaccinated at 5-17 months of age (referred to as children), and those first vaccinated at 6-12 weeks of age (referred to as young infants) who received the RTS,S/AS01 vaccine along with their routine childhood immunizations. Participants were randomized into 3 groups – the first group received three doses of the RTS,S/AS01 vaccine followed 18 months later by a booster dose; the second group received three doses of the RTS,S/AS01 vaccine without a booster; and the third group received a comparator vaccine. All participants received an ITN. Children were followed for an average of 48 months and infants for an average of 38 months.
We found that vaccine efficacy was modest. Vaccine efficacy against clinical malaria in children was 36% with a booster and 28% without, and vaccine efficacy against severe malaria was 32% with a booster and non-significant without. Efficacy results in young infants were lower than those in children– vaccine efficacy against clinical malaria was 36% with a booster and 28% without, and vaccine efficacy against severe malaria was non-significant.
However, impact, defined as the number of cases averted per 1000 participants vaccinated, was substantial in both age-categories, and highest where malaria burden was greatest. In children who received the booster, during 4 years follow-up, 1700 cases of clinical malaria were averted per 1000 children vaccinated. In young infants, during 3 years follow-up, nearly 1000 cases were averted per 1000 young infants vaccinated.
The safety findings were comparable overall in the different study arms, but two safety findings are notable. Meningitis occurred more frequently among children (but not young infants) who received RTS,S/AS01 than among those who received the comparator vaccines. There was no relationship between when the vaccine was administered and when meningitis occurred, most cases occurred in only two study sites, and the finding may be due to chance. If RTS,S/AS01 is licensed, post-licensing studies will be done to establish the significance of this finding. Both children and young infants experienced more episodes of fever and associated febrile convulsions during the 7 days following vaccination; convulsions occurred in 2.2 - 2.5/1000 vaccine doses.
22 Apr HPV Vaccine Provides Protection at Multiple Sites
MedicalResearch.com Interview with:
Daniel C. Beachler, PhD Postdoctoral fellow
Infections and Immunoepidemiology Branch of the
National Cancer Institute (NCI)
Medical Research: What is the background for this study? What are the main findings?
Dr. Beachler: HPV is a common sexually transmitted infection. Individuals can acquire HPV infections in the epithelium of their cervical, anal and oral sites, and occasionally these infections lead to cancer. There are three prophylactic HPV vaccines on the market that can protect against HPV at these sites among those not been previously exposed to HPV.
This study examined the effect of HPV vaccination of 18-25 year old women at all three anatomic sites. The combined multi-site HPV vaccine efficacy has not been reported previously. It was unknown whether the vaccine may protect non-infected sites against HPV infection or re-infection in women exposed to HPV prior to vaccination.
We observed that the HPV vaccine provides the strongest protection at all three sites among women unexposed to HPV before vaccination. Additionally, we observed some protection at the non-infected sites in women who were previously infected with HPV.
03 Apr High-Dose Flu Vaccine Prevented More Influenza Infections In Elderly Than Standard Dose
MedicalResearch.com Interview with:
Dr Richard Forshee PhD
Associate Director for Research in the Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD
On behalf of the study authors
Medical Research: What is the background for this study? What are the main findings?
Dr. Forshee: Influenza continues to be a major public health concern causing illness, hospitalization, and death. The elderly are at highest risk for seasonal influenza complications, including hospitalization and death. As people grow older their ability to raise a strong protective immune response can weaken. The availability of a vaccine that uses a higher dose to induce a stronger immune response could reduce the serious impact of influenza in this age group. The purpose of this study was to determine whether a high-dose inactivated influenza vaccine was more effective for prevention of probable influenza infections and influenza-related hospital admissions, compared to standard-dose inactivated influenza recipients.
In December 2009, the U.S. Food and Drug Administration (FDA) licensed Fluzone High Dose, an injectable inactivated trivalent seasonal influenza vaccine for people ages 65 years and older. This high-dose vaccine contains four times more hemagglutinin—the active ingredient in influenza vaccines that cause the human body to produce antibodies against the influenza viruses—than the standard-dose vaccine. The FDA approved the high-dose vaccine using the accelerated approval regulatory pathway, which allows the agency to approve products for serious or life-threatening diseases based on reasonable evidence of a product’s effectiveness. This pathway reduces the time it takes for needed medical products to become available to the public. Studies conducted prior to licensure showed an enhanced immune response to the high-dose vaccine compared with the standard-dose vaccine in individuals 65 years of age and older indicating that the high-dose vaccine was reasonably likely to be more effective in preventing influenza disease.
As part of the accelerated approval process, the manufacturer, Sanofi Pasteur, was required to conduct a randomized clinical study post-licensure to confirm that the high-dose vaccine decreased seasonal influenza disease after vaccination relative to standard dose vaccine. This confirmatory study demonstrated that the high–dose vaccine prevented 24% more cases of laboratory-confirmed influenza illness compared to standard-dose vaccines in people 65 years of age and older. However, the study was not large enough to determine efficacy of the vaccine against severe disease.
A team of scientists from FDA, the Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, and Acumen LLC ( an independent research organization) studied the relative effectiveness of the high-dose influenza vaccine in the U.S. population ages 65 years and older. The observational study, which covered the 2012-2013 influenza season, found a significant reduction both in influenza-associated illness and in influenza-related hospitalizations among individuals who received the high-dose vaccine, compared to those receiving the standard dose.
Additional background about this study: “Comparative effectiveness of high-dose versus standard-dose influenza vaccines in US residents aged 65 years and older from 2012 to 2013 using Medicare data: a retrospective cohort analysis” is available at:
http://dx.doi.org/10.1016/S1473-3099(14)71087-4
A commentary on the study titled “Novel observational study designs with new influenza vaccines” is available at:
http://dx.doi.org/10.1016/S1473-3099(15)70020-4
27 Mar Pediatric Meningococcal Vaccine Immunity May Wane By Adolescence
MedicalResearch.com Interview with: Dr Fiona McQuaid Clinical Research Fellow University of Oxford, United Kingdom Medical Research: What is the background for this study? Response: Meningococcal B disease is a common cause of sepsis and meningitis with significant mortality and morbidity. A multicomponent vaccine against serogroup B meningococcus has been licensed for use in the Europe, Australia, Canada and recently the USA (though only in the 10-25 years age group) but questions remain about how long the bactericidal antibodies induced by infant vaccination persist and the likely breath of strain coverage. This was a follow on study looking at a group of children aged 5 years who had been vaccinated as infants and a different group who were vaccinated for the first time at 5 years of age. Medical Research: What are the main findings? Response: The percentage of children with protective antibody levels who had been immunized as infants fell in the 20 months since their last immunization but this varied by the strain of meingococcus B tested and by the different infant/toddler vaccination schedules. The children who were vaccinated for the first time at 5 years of age showed a good antibody response, but most reported pain and redness around the site of vaccination and 4-10% had a fever.07 Mar Unvaccinated Children Have Higher Risk Of Developing Shingles
MedicalResearch.com Interview with: Su-Ying Wen, MD Chief of Department of Dermatology, Taipei City Hospital, Renai Branch, Taipei City, Taiwan Department of Dermatology, Taipei City Hospital, Renai Branch, Taipei City, Taiwan Medical Research: What is the background for this study? What are the main findings? Dr. Su-Ying Wen: Though herpes zoster is seen as a disease of the elderly, it can affect individuals in any age group including children. There are limited population-based data regarding pediatric herpes zoster. We reported a higher incidence rate of pediatric herpes zoster than in previous studies. The higher incidence observed in this population-based study might be because it was measured in a cohort of children who were all infected with varicella rather than as other reports including individuals free of varicella infection in the denominator. Children younger than 2 years at the diagnosis of varicella had a significantly higher risk and shorter duration of developing herpes zoster.28 Feb HPV-16/18 Vaccine Provides Some Cross Protection To Other Cancer-Causing Subtypes
MedicalResearch.com Interview Invitation Frank Struyf MD PhD Director, Lead Clinical Development HPV vaccines at GlaxoSmithKline Biologicals GlaxoSmithKline Vaccines, Rixensart, Belgium MedicalResearch: What is the background for this study? What are the main findings? Dr. Struyf: Cervical cancer is the fourth most common cancer among women, with estimates from 2012 indicating that there are 528,000 new cases and 266,000 deaths each year worldwide, the majority of cases occurring in developing countries (reference: Globocan 2012 at http://globocan.iarc.fr/old/FactSheets/cancers/cervix-new.asp). Persistent infection with oncogenic human papillomavirus (HPV) is a necessary condition for the development of invasive cervical cancer. HPV type 16 (HPV-16) and HPV-18 are found in approximately 70% of cases. We conducted the Papilloma Trial Against Cancer in Young Adults (PATRICIA), a multinational clinical trial in 14 countries in Europe, the Asia-Pacific region, North America, and Latin America and enrolled over 18,000 women. The trial showed that the HPV-16/18 AS04-adjuvanted vaccine not only prevented persistent infections and high-grade cervical lesions associated with HPV types 16 and/or 18 included in the vaccine, but also protected against some common related oncogenic HPV types not included in the vaccine. However, during the analysis of this trial, we also noticed that for some rare nonvaccine oncogenic HPV types, the vaccine efficacy against infections did not seem to match the efficacy against lesions associated with the same HPV type. To investigate this, we re-analyzed the samples from the trial using a different PCR method and found that the HPV PCR methodology used per protocol may have underestimated the efficacy for non-vaccine HPV types in cases of multiple infections. While these results do not replace the results generated according to the study protocol and included in the product label, they are reassuring, as they confirm the cross-protective efficacy of the HPV-16/18 vaccine against some HPV types related to those included in the vaccine.28 Feb New Ninevalent HPV Vaccine Gives Greater Protection Against Cervical Cancer and Genital Warts
MedicalResearch.com Interview with:
Elmar A. Joura, M.D
Gynecologist
University of Vienna
MedicalResearch: What are the main findings of this study?
Dr. Joura: This study demonstrates that the new ninevalent HPV vaccine induces a good immunogenicity against HPV 6/11/16/18 and gives a 97% protection against disease caused by HPV 31/33/45/52/58. This has a potential of a 90% reduction of cervical cancer and other HPV related cancers and a similar protection against genital warts. The full benefit is seen in persons without current HPV infection, this reinforces early vaccination against HPV. The safety profile was favourable.
10 Feb Measles Mumps Rubella Vaccine in Adults: CDC Reports Excellent Safety Record
MedicalResearch.com Interview with: Tom Shimabukuro, MD, MPH, MBA Captain, U.S. Public Health Service Deputy Director Immunization Safety Office Centers for Disease Control and Prevention (CDC) Medical Research: What is the background for this study? What are the main findings? Response: CDC conducted a study looking at reports of adverse events (possible side effects) following measles, mumps, and rubella (MMR) vaccination in adults. Researchers reviewed the Vaccine Adverse Event Reporting System (VAERS) database for U.S. reports of adults aged 19 years and older who received MMR vaccine from January 1, 2003 to July 31, 2013. During this period, VAERS received 3,175 U.S. reports after MMR vaccine in adults. The most common signs and symptoms for all reports were fever (19%), rash (17%), pain (13%), and joint pain (13%). The study included adults only, a population for which there is limited safety data for this vaccine. This study further supports the MMR vaccine’s safety. Researchers did not find any new or unexpected safety concerns.04 Feb Pneumococcal Vaccines Prove Highly Effective In Preventing Severe Illness
MedicalResearch.com Interview with:
Dr Matthew R Moore, MD
National Center for Immunization and Respiratory Diseases,
Centers for Disease Control and Prevention, Atlanta, GA, USA
MedicalResearch: What is the background for this study?
Dr. Moore: Since introduction, pneumococcal conjugate vaccines have resulted in dramatic decreases in the number of cases of invasive pneumococcal disease in both children and adults. The 7-valent pneumococcal conjugate vaccine (PCV7) was introduced into the routine infant immunization program in the United States in 2000. It was recommended for infants using a 4-dose schedule: 2, 4, 6, and 12 through 15 months of age. Studies showed that PCV7 was highly effective in preventing invasive pneumococcal disease. In 2010, the 13-valent pneumococcal conjugate vaccine (PCV13) replaced PCV7 using the same 4-dose schedule. PCV13 is similar to PCV7, but includes protection against six additional serotypes of Streptococcus pneumoniae. There are more than 90 serotypes of pneumococcal bacteria.
Streptococcus pneumoniae, or pneumococcus, is a major cause of illness and death globally. Pneumococcus can cause many types of illness that ranging from mild to life-threatening, including pneumonia, ear and sinus infections, meningitis, and bacteremia. Some of these infections are considered invasive because they invade parts of the body that are normally free from bacteria. Invasive pneumococcal disease, including meningitis and bacteremia, is often severe and can be deadly.
MedicalResearch: What are the main findings?
Dr. Moore: Invasive pneumococcal disease decreased substantially in the first 3 years after PCV13 was introduced into the U.S. infant immunization schedule. By June 2013, more than 30,000 cases of invasive pneumococcal disease and 3,000 deaths are estimated to have been prevented in the United States due to PCV13. Children under the age of five, which is the age group that actually received the vaccine, experienced the greatest and quickest benefit from PCV13. For example, the overall number of cases of invasive pneumococcal disease decreased by 64% in this age group between 2010 and 2013. Significant decreases were seen as early as six months after the immunization recommendation was made.
Adults, who were not targeted for vaccination, also experienced health benefits from PCV13 introduction. For example, the overall number of cases of invasive pneumococcal disease decreased by 32% for adults aged 18 to 49 years, while adults 65 and older experienced a more modest 12% decrease. These reductions are further evidence that both PCV7 and PCV13 reduce the spread of pneumococcus, which is why vaccinating children leads to disease reductions in adults.
For both children and adults, the greatest reductions were seen in the number of cases of invasive pneumococcal disease that were caused by serotypes that are covered by PCV13 but not PCV7 (serotypes 19A and 7F specifically).
04 Feb Household Members Protected Against Some Rotavirus Infections When Infants Vaccinated
Posted at 14:22h
in Author Interviews, CDC, Gastrointestinal Disease, Infections, Pediatrics, Vaccine Studies
MedicalResearch.com Interview with:
Margaret M. Cortese MD
Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
Medical Research: What is the background for this study? What are the main findings?
Dr. Cortese: The introduction of rotavirus vaccine in the United States resulted in a dramatic reduction in hospitalizations and emergency department care for rotavirus disease among young children, as well as provided indirect protection to unvaccinated peers.
However, what our study looked at was whether or not older children and adults may experience indirect protection from having children in the house who are vaccinated for rotavirus.
We used 2008-2012 Marketscan claims data to compare gastroenteritis rates among households whose child had received rotavirus vaccine with households whose child did not receive vaccine.
We found statistically significantly lower rates of hospitalization from rotavirus gastroenteritis or unspecified-gastroenteritis in vaccinated households among all persons 20-29 years and females 20-29 years during the 2008-2009 rotavirus season as well as males 30-39 years in the 2009-2010 season. Lower emergency department gastroenteritis rates occurred in vaccinated households among females 20-29 years during the 2009-2010 season and individuals 5-19 years during the 2010-2011 season.
13 Jan New Dengue Vaccine Trial in Latin America Demonstrates Efficacy
MedicalResearch.com Interview with:
Gustavo Dayan, MD
Director, Clinical Development
Sanofi Pasteur Discovery Drive
Swiftwater, PA 18370
Medical Research: What is the background for this study? What are the main findings?
Dr. Dayan: This is the first dengue vaccine efficacy trial conducted in Latin America. The trial met its primary objective showing an efficacy of 60.8% against symptomatic VCD (virologically confirmed dengue) after a 3-dose vaccination schedule. Serotype-specific efficacy was also demonstrated against all four serotypes. Furthermore, the dengue vaccine candidate effectively reduced hospitalization due to dengue by 80.3% and severe dengue disease by 95.5% over the 25-month study period.
22 Dec No Adverse Effects From Inadvertent HPV Vaccine During Pregancy
MedicalResearch.com Interview with: Pedro Moro MD MPH Immunization Safety Office, Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention Medical Research: What is the background for this study? What are the main findings? Dr. Moro: Gardasil® is a human papillomavirus (HPV) vaccine recommended for all girls and boys at age 11 or 12, and teens and young adults who did not get the vaccine when they were younger. Because there is limited safety data available on use of the vaccine during pregnancy, it is not currently recommended for pregnant women. However, some pregnant women will inadvertently receive Gardasil® because they do not yet know that they are pregnant at the time of vaccination. The study reviewed non-manufacturer reports to the Vaccine Adverse Event Reporting System (VAERS) about pregnant women who received Gardasil®. VAERS is a national vaccine safety surveillance program co-administered by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts reports of health problems that occur after any US-licensed vaccine (these are called adverse events). VAERS may also accept reports not describing any health problem but vaccination errors (for example, administration of a vaccine not recommended to a particular group of people like pregnant women). VAERS is an early-warning system and cannot generally assess if a vaccine caused an adverse event. After reviewing all non-manufacturer reports of Gardasil vaccination during pregnancy, this study found no unexpected patterns of safety issues for pregnant woman who received Gardasil®, or for their babies. This finding is reassuring and reconfirms the safety of this vaccine for pregnant women, as was previously reported by the pregnancy registry maintained by Gardasil®’s manufacturer.15 Dec Researchers Aim To Make Influenza Vaccine More Effective For High Risk Patients
MedicalResearch.com Interview with:
Adrian Egli, MD PhD Research Group leader
Infection Biology Laboratory
Department of Biomedicine
University of Basel and University Hospital Basel
Basel, Switzerland
Medical Research: What is the background for this study? What are the main findings?
Dr. Egli: Infections with influenza viruses are associated with a high morbidity and mortality. In particular, people with a weak immune system are at danger for more severe complications. This includes elderly people, pregnant women, patients after transplantation, patients with HIV infection, chronic diseases such as diabetes and many more. In these high-risk groups, annual vaccination is clearly recommended.
However, due to the immunsuppressive condition the immune response to the influenza vaccine is often reduced. The seroconversion rate - a 4-fold antibody titer increase upon vaccination - is one of the key markers for a successful vaccination. In young adults the seroconversion rate is normally >85%; however, in patients with immunosuppression, this can be lower than 40%. Improving vaccine efficacy is one of the key focuses of my research group. We try to understand, how to improve vaccines and better protect the people at the highest risks for influenza-associated complications.
In this study, we could show that an important cytokine, called Interferon lambda, is clearly associated with the vaccine induced antibody response upon influenza vaccination. We could show that genetic polymorphisms, in one of the Interferon lambda gene family (IFNL3), are modulating the expression of this gene. This strongly affects the cross talk between the innate and adaptive immune response in the context of vaccination. We observed that, the more Interferon lambda is present, the lower the antibody response is. People with a lower expression of Interferon lambda had a significant higher response to the vaccine. Therefore, we developed substances to block the effect of Interferon lambda. We could show in vitro, that due to the Interferon lambda blockade, the antibody production was improved.
14 Dec HPV Vaccine Not Linked To Increased Risky Sexual Behavior
MedicalResearch.com Interview with:
Leah M. Smith PhD
Department of Epidemiology, Biostatistics, and Occupational Health (Smith, Kaufman, Strumpf)
McGill University, Montréal, Quebec
Medical Research: What is the background for this study? What are the main findings?
Dr. Smith: The human papillomavirus (HPV) vaccine protects against types of HPV that cause cervical cancer and anogenital warts. The vaccine first became available in 2006. Since then, it has faced a great deal of controversy surrounding, in part, some of the unanswered questions about the real-world effects of the vaccine, especially on the young girls targeted for immunization. One issue that has received a great deal of public attention has been the concern that HPV vaccination might give girls a false sense of protection against all sexually transmitted infections that might lead them to be more sexually active than they would otherwise. As a result, some parents have been reluctant to have their daughters vaccinated. It is also reason why some religious groups have spoken out against the vaccine. This question is further important from a public health perspective because increases in risky sexual behaviour would inevitably also lead to increases in teen pregnancy and sexually transmitted infections (excluding anogenital warts), which would of course undermine the potential health benefits of the vaccine.
In this study, we directly addressed the question of whether HPV vaccination has led to increases in pregnancy and non-HPV-related sexually transmitted infections (both of which are proxies for risky sexual behaviour) among adolescent girls.
In our study of over 260,000 girls, we did not find any evidence that the HPV vaccine had a negative impact on these outcomes.
14 Dec Novel Vaccine Fights MRSA Infections
MedicalResearch.com Interview with:
Dr. Michael Yeaman Ph.D.
Professor of Medicine, Infectious Disease Specialist
Chief, Division of Molecular Medicine
David Geffen School of Medicine at UCLA
Los Angeles Biomedical Research Institute
Harbor-UCLA Medical Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Yeaman: In the U.S. and around the globe, skin and soft tissue infections caused by
methicillin-resistant Staphylococcus aureus (MRSA) continue to endanger the
health and lives of patients and otherwise healthy individuals. Treatment is
difficult because MRSA is resistant to many antibiotics, and the infections
can recur, placing family members and other close contacts at risk of
infection.
Infectious disease specialists at the Los Angeles Biomedical Research
Institute at Harbor-UCLA Medical Center (LA BioMed) tested a new
investigational vaccine, NDV-3, and found it holds new hope for preventing
or reducing the severity of infections caused by the "superbug" MRSA.
In the study, which was published Dec. 8 in the Proceedings of the National
Academy of Sciences USA, the researchers reported that NDV-3, employing the
recombinant protein Als3, can mobilize the immune system to fight off MRSA
skin infections in an experimental model. The researchers found the vaccine
works by enhancing molecular and cellular immune defenses of the skin in
response to MRSA and other S. aureus bacteria in disease models.
This is the first published study to demonstrate the effectiveness of a
cross-kingdom recombinant vaccine against MRSA skin infections. NDV-3 is
unique as it is the first vaccine to demonstrate it can be effective in
protecting against infections caused by both S. aureus and the fungus
Candida albicans. NDV-3 represents a novel approach to vaccine design that
pioneers an approach termed convergent immunity.
24 Nov HPV Vaccination Rates Leaves Room For Improvement
MedicalResearch.com Interview with:
Dr. Raquel Qualls-Hampton MD, MS
Assistant Professor
University of North Texas Health Science Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Qualls-Hampton: There are currently two vaccines approved by the Food and Drug Administration (FDA)—Gardasil for males and Gardasil and Cervix for females – that protect against the human papilloma virus (HPV). These vaccines are recommended by the ACIP for females ages 9 to 26 years and males ages 9 to 21 years. Both vaccines protect males and females against some of the most common types of HPV. HPV vaccines are administered in three doses over six months and are considered safe and effective. However, the promise of these vaccines is going unfulfilled as initiation and completion rates for the three doses are suboptimal among females and males.
Nationally, although HPV vaccination initiation coverage is increasing, overall vaccine completion rates are at suboptimal levels and below the U.S. Department of Health and Human Services’ Healthy People 2020 initiative target of 80%. Thus, many states are turning to legislative interventions in efforts to increase initiation and completion rates. This study examines HPV vaccination legislative initiatives and their impact, specifically in estimating state legislation’s effects on HPV vaccine initiation, completion and patient care provider recommendations by gender.
23 Nov Flu Vaccination May Be Effective Even When Circulating Strain Different From Vaccine
MedicalResearch.com Interview with: Maryam Darvishian MSc Department of Epidemiology, University Medical Center Groningen, Unit of PharmacoEpidemiology and PharmacoEconomics (PE2), Department of Pharmacy, University of Groningen, and Department of Mathematics and Computer Science, Eindhoven University of Technology, Eindhoven, Netherlands Medical Research: What is the background for this study? Reply: In most developed countries, seasonal influenza vaccine is the standard care for elderly people, but there exists still discussions on whether vaccination is effective. Conducting RCT is not considered ethical and thus the main body of evidence comes from observational studies. Unfortunately, these studies (e.g. cohort studies) are susceptible to different sources of biases especially selection bias which makes it difficult to judge the effectiveness. In recent years test-negative design (TND) studies has been designed. It is a special type of case-control study which would limit the bias, due to similar health care-seeking behavior in cases and controls. The current study is a meta-analysis of TND case-control studies. It is the first meta-analysis of this type of studies and also the first meta-analysis that combined 35 studies for estimation of influenza vaccine effectiveness. More specifically, the meta-analysis assesses the influenza vaccine effectiveness against laboratory-confirmed influenza (LCI) among the elderly population.15 Nov Tdap Vaccination Safety During Pregnancy Studied
MedicalResearch.com Interview
Elyse O. Kharbanda MD MPH
HealthPartners Medical and Dental Group
Medical Research: What is the background for this study? What are the main findings?
Dr. Kharbanda: In 2010, due to a pertussis outbreak and neonatal deaths, the California Department of Public Health recommended that the Tdap vaccine be administered during pregnancy. Tdap is now recommended by the Advisory Committee on Immunization Practices (ACIP) for all pregnant women during each pregnancy. We wanted to assess the impact of this recommendation.
The main findings were that Tdap vaccination during pregnancy was not associated with increased risk for hypertensive disorders of pregnancy, preterm birth, or having a baby who is small for his or her gestational age.
The study found a small increased risk for being diagnosed with chorioamnionitis, an inflammation of the fetal membranes caused by bacterial infection. These findings should be interpreted with caution as the magnitude of the risk was small. In addition, there was no associated risk for preterm birth, which often occurs as a result of chorioamnionitis. Furthermore, among the subset of women with a chorioamnionitis diagnosis whose charts were reviewed, many did not have a clinical picture that was clearly consistent with chorioamnionitis.
07 Nov Childhood Pneumococcal Vaccine Linked To Sharp Decline In Hospitalizations
MedicalResearch.com Interview with:
Marie R Griffin MD MPH
Director, Vanderbilt MPH Program
Department of Health Policy Vanderbilt University Medical Center
Nashville TN 37212
Medical Research: What is the background for this study? What are the main findings?
Dr. Griffin: In Tennessee, the introduction in 2010 of a new pneumococcal vaccine for infants and young children was associated with a 27 percent decline in pneumonia hospital admissions across the state among children under age 2. The recent decline in Tennessee comes on top of an earlier 43 percent decline across the United States associated with the introduction in 2000 of the first pneumococcal vaccine for children under 2 years of age.
28 Oct International Societies Urge Expedited Ebola Vaccine Development
MedicalResearch.com Interview with:
Prof. Clive Maurice Gray
Division of Immunology, Institute of Infectious Diseases and Molecular Medicine,National Health Laboratory Services
University of Cape Town, Cape Town, South Africa
Medical Research: What is the background for this report? What are the main findings?
Prof. Gray: This report is a response on behalf to the International Union of Immunology Societies (IUIS) and is designed to focus a message from the global immunology community to those who are making vaccines and therapies implementing clinical trials and very importantly on Governments and funding bodies. Time is not our side and that vaccine efforts need to be expedited and that production of therapeutics needs to be ramped up. Due to the fact that many people in West Africa are dying, we wish to convey a strong message that to curb this outbreak, therapies and especially vaccines must be rolled out as soon as possible.
22 Oct Flu Mutations Led To More Disease Among Middle-Aged Adults
MedicalResearch.com Interview with
Scott E. Hensley, Ph.D.
Assistant Professor, The Wistar Institute
Philadelphia, PA 19104
Medical Research: What are the main findings of the study?
Dr. Hensley: We found that H1N1 viruses recently acquired a mutation that abrogates binding of influenza antibodies that are present in a large number of middle-aged adults. We propose that this mutation lead to increased disease among middle-aged adults during the 2013-2014 influenza season.
20 Oct PCV13 Vaccine Markedly Protects Elderly Against Community Acquired Pneumonia
MedicalResearch.com Interview with:
Dr. Susanne Huijts
Research Physician at UMCU Julius Center for Health Sciences Pulmonary resident, UMC Utrecht Center
Utrecht, Netherlands
Medical Research: What are the main findings of the study?
Dr. Huijts: The CAPiTA trial evaluated the efficacy of the 13-valent pneumococcal conjugate vaccine (PCV13) in adults of 65 years and older. In the per protocol analysis vaccine efficacy of 45.6% was demonstrated for the first episode vaccine type (VT) pneumococcal community acquired pneumonia (CAP); 45.0% for the first episode of non-bacteremic/ non-invasive (NB/NI) VT-CAP, and 75.0% for the first episode of VT-invasive pneumococcal disease.
01 Oct New HPV Vaccine Has Potential To Prevent Nearly All Cervical Pre-Cancers
MedicalResearch.com Interview with:
Elmar A. Joura, MD
Department of Gynaecology and Obstetrics
Medical University of Vienna, Comprehensive Cancer Center
Vienna, Austria
Medical Research: What are the main findings of the study?
Dr. Joura: The upcoming ninevalent vaccine has the potential to prevent 85% of the cervical precancers and surgeries such as LEEP (conization)