U.S. Supreme Court affirms National Childhood Vaccine Injury Act

The U.S. Supreme Court decided 6-2 to affirm a lower court ruling upholding the National Childhood Vaccine Injury Act. The Act prevents civil suits against manufacturers of FDA-approved childhood vaccines “based on a claim that a particular vaccine should have been designed differently.” The opinion of the Court in the case – Bruesewitz v. Wyeth – stated that “[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”  In an amicus brief, the American Academy of Pediatrics and over 20 other professional and public health organizations argued that a ruling against Wyeth could “precipitate the same crisis that Congress sought to avert in passing the Vaccine Act: ‘the very real possibility of vaccine shortages, and, in turn increasing numbers of unimmunized children, and, perhaps, a resurgence of preventable diseases.’” The court’s opinion is available at: http://www.supremecourt.gov/opinions/10pdf/09-152.pdf.

IVI and Sanofi Pasteur to collaborate on dengue vaccine accessibility

The International Vaccine Institute (IVI) and Sanofi Pasteur announced “their intent to work together towards creating the conditions to make a dengue vaccine widely accessible to countries where this disease is endemic.” Dr. Ragnar Norrby, Chairman of the IVI Board of Trustees, said, “A dengue vaccine represents the most viable prevention tool in our quest to reduce the growing number of dengue infections occurring globally each year. We thank Sanofi Pasteur for their commitment to reducing the considerable burden placed on communities and health systems around the world due to dengue and dengue hemorrhagic fever.“ Earlier this month, the IVI announced the launch of the Dengue Vaccine Initiative, in collaboration with the Sabin Vaccine Institute, the Johns Hopkins University, and the World Health Organization. Through a $6.9 million grant from the Bill & Melinda Gates Foundation, DVI “will accelerate the availability and utilization of safe, affordable and broadly protective vaccines to combat dengue.”

http://www.ivi.org/event_news/news_view.asp?enid=118

WHO: priorities for vaccine prequalification evaluations – 2011-2012

WHO released the priorities for vaccine evaluations for prequalification for 2011-2012. The prioritization list below “is a tool published every two years by the WHO by the prequalification programme to guide decisions as to the vaccines on which to focus resources.” Vaccines are categorized in four groups: high, medium, low and no priority. The priority list was developed by consultation between WHO and the two United Nations purchasing agencies (UNICEF and the Pan American Health Organization Revolving Fund) which use the prequalification service for vaccines. The prioritization exercise takes into account needs from WHO programmes (e.g. polio, measles, rabies) and the International Health Regulations, as well as vaccines defined globally as priority for accelerated introduction.

WHO said that in the consultation process for the current list, vaccines were considered if, based on information available to the UN purchasing agencies and WHO, they were already available in the market or were expected to become available during the biennium 2011-2012. The criteria used to assign priorities include:

a) Demand in the respective UN-supplied markets, with consideration given to plans for introduction;
b) WHO programmatic needs;
c) recommendations of WHO’s Strategic Advisory Group of Experts (SAGE) on immunization ; and
d) security of supplies: number, diversity, and production capacity of suppliers in the market.

Vaccines prequalification priority list 2011-12

– High priority vaccines

– Bivalent oral polio (bOPV1+3)

– DTwP based pentavalent combination (fully liquid DTwP-Hep B-Hib)

– Inactivated polio (IPV)

– Meningococcal A-containing conjugate

– Meningoccocal AC-containing polysaccharide

– Meningococcal W-containing polysaccharide

– Meningococcal W-containing conjugate

– Pneumococcal conjugate

– Rotavirus

– Trivalent oral polio (tOPV)

– Yellow fever

Vaccines of high programmatic interest but not available for supply in January 2011 (e.g. dengue; malaria; and new formulations of current vaccine types with enhanced stability outside of the currently accepted storage conditions) may be considered as high priority if they become available before the end of the period for which the list is in force.

http://www.who.int/immunization_standards/vaccine_quality/pq_priorities/en/index.html

Global Immunization News (25 February 2011)

WHO released the newest issue of Global Immunization News (25 February 2011) http://www.who.int/entity/immunization/GIN_February_2011.pdf Included in this issue:

ANNOUNCEMENTS FROM THE SIVAC INITIATIVE

25/02/2011 from Julia Blau, AMP

The briefing described below is available in the Center of Expertise on the NITAG Resource

– The “Introduction to Health Economic Evaluations for NITAG members briefing” is an e-learning tool that provides NITAG members with a basic background on health economic evaluations applied to immunization. It contains 4 modules of 10 to 40 minutes each:

– Module 1: The usefulness of economic evaluations for public health

– Module 2: The different types of economic evaluations

– Module 3: The main methodological issues of an economic evaluation

– Module 4: Interpretation of cost-effectiveness ratios

http://www.nitag-resource.org/en/training/rapid-briefing.php

Twitter Watch: 28 February 2011

Twitter Watch

A selection of items of interest this week from a variety of twitter feeds from NGOs and other sources

SingerPeter Peter Singer
Great photo of polio vaccination @gatesfoundation! Is there an ethical obligation to complete polio eradication? Yes! http://bit.ly/dfbjT2
26 Feb

CDCgov CDC.gov
Protect your child against #rotavirus. #Vaccinate beginning at 2 months of age. http://go.usa.gov/g7A
25 Feb

USAID USAID
Podcast of Deputy Assistant Admin for Global Health Amie Batson on the importance of #vaccines: @GLOBALHEALTHorg http://tinyurl.com/643gtse
24 Feb

MalariaVaccine PATH MVI
RT @PATHtweets: RTS,S is the first malaria vaccine candidate to ever reach large-scale Phase 3 clinical testing. http://ow.ly/3XFed
22 Feb

Health outcomes in economic evaluation: the QALY and utilities

British Medical Bulletin
Volume 96 Issue 1 December 2010
http://bmb.oxfordjournals.org/content/current

Articles
Sarah J. Whitehead and Shehzad Ali

Health outcomes in economic evaluation: the QALY and utilities
Br Med Bull (2010) 96(1): 5-21 first published online October 29, 2010 doi:10.1093/bmb/ldq033

Abstract
The quality-adjusted life year (QALY) is routinely used as a summary measure of health outcome for economic evaluation, which incorporates the impact on both the quantity and quality of life. Key studies relating to the QALY and utility measurement are the sources of data. Areas of agreement include the need for a standard measure of health outcome to enable comparisons across different disease areas and populations, and the methods used for valuing health states in utility measurement. Areas of controversy include the limitation of the QALY approach in terms of the health benefits it can capture, its blindness towards equity concerns, the underlying theoretical assumptions and the most appropriate generic preference-based measure of utility. There is growing debate relating to whether a QALY is the same regardless of who accrues it, and also the issue as to who should value health states. Research is required to further enhance the QALY approach to deal with challenges relating to equity-weighted utility maximization and testing the validity of underlying assumptions. Issues around choosing between condition-specific measures and generic instruments also merit further investigation.