PneumoFOCUS

Bulletin of GAVI's PneumoADIP at Johns Hopkins Bloomberg School of Public Health
PneumoADIP: Pneumococcal Vaccines Accelerated Development and Introduction Plan

Volume 6, No. 2 February/March 2009

Director's Note:

Dear colleagues,
The first few months of this year have seen lots of exciting news and transitions for our team. The group you have known as the PneumoADIP will continue working to elucidate and fight the causes of childhood pneumonia and pneumococcal disease through several new grants.  

For example, we're pleased to note that we've received grants totaling more than $40 million from the Bill and Melinda Gates Foundation to study the etiology of childhood pneumonia. The new initiative, called PERCH (Pneumonia Etiology Research for Child Health), aims to build a new, rigorous evidence base by studying the causes of pediatric pneumonia in five to ten countries across the developing world using state-of-the-art diagnostics. News of our other projects will follow in future editions.

In this edition of the PneumoFOCUS we bring you news of exciting progress on new vaccines to prevent, and drugs to treat, pneumococcal infections. We highlight the publication of methodologies used by the Global Burden of Hib and Pneumococcal Disease working group led by experts at the WHO, PneumoADIP and Hib Initiative. In our research section you will find new studies on bacteremia outcomes in Mozambique, evidence of serotype-specific severity of pneumococcal infection outcomes and a review of PCV-7 impact post-introduction.

Finally, in our finance section, we highlight something many of you already know: that research and product development for the major killers of children worldwide, pneumonia and diarrhea, are underfunded. In addition, the global economic downturn is likely to impact the research community, as well as those working to provide access to vaccines and other interventions to children in the developing world. As you've seen in our recent PneumoALERT, the announcement of World Pneumonia Day taking place for the first time on November 2nd this year gives us the opportunity to speak up and be sure that financial concerns won’t prevent us from saving children's lives.

With best wishes,
Orin S. Levine, PhD
Executive Director, GAVI's PneumoADIP
Johns Hopkins Bloomberg School of Public Health
 

In this issue:

Media:

  1. Literature search method to determine the global burden of Hib and pneumococcal disease published by WHO
  2. 10-Valent PCV, Synflorix, approved by European Authority
  3. Researchers devise new approach for the development of drugs to fight pneumococcus
  4. Africa Regional Pneumococcal Symposium and Meeting of Surveillance Investigators held in South Africa
  5. Intercell AG begins Phase I trial of pneumococcal vaccine

Research:

  1. Community-acquired bacteremia is a significant cause of pediatric hospital admission and death in rural Mozambique
  2. Study examines association of pneumococcal serotype with risk of severe or fatal outcomes
  3. Impact of routine immunization with 7-valent pneumococcal conjugate vaccine (PCV) reviewed

Finance:

  1. New study shows that many serious diseases are significantly underfunded

Upcoming Events

Online Poll Results

 

MEDIA

1. Literature search method to determine the global burden of Hib and pneumococcal disease published by WHO

A comprehensive literature review of published and unpublished reports of Hib and pneumococcal disease among children less than five years of age was undertaken to provide input parameters for a World Health Organization (WHO) modeling study directed at estimating global, regional, sub-regional and country level Hib and pneumococcal disease burden. The document describing the literature search method, data abstraction tools and analysis of studies identified by the search is now available online. The data from this literature search, carried out between 2005 and 2007, was then used to populate models to estimate the global disease burden of Hib and Spn and will be published elsewhere (check the PneumoFOCUS for updates).

2. 10-Valent PCV, Synflorix, approved by European Authority

GlaxoSmithKline's (GSK) 10-valent pneumococcal conjugate vaccine, Synflorix, received final approval from The European Commission on March 31st. The decision follows on a January 2009 recommendation for approval by the European Medicines Agency (EMEA). The vaccine includes coverage of serotypes 1, 5 and 7F in addition to the seven serotypes in the PCV7 formulation (brand name Prevenar, Wyeth) and is indicated to protect children between 6 weeks and 2 years of age against invasive pneumococcal disease and acute otitis media.

3. Researchers devise new approach for the development of drugs to fight pneumococcus

A team of scientists led by Jesús M. Sanz (Miguel Hernandez University, Spain) and Marten Merkx (Eindhoven University of Technology, Netherlands) have developed the foundation for a potential new type of anti-pneumococcal drug that would work by inhibiting the pneumococci’s ability to bind the choline-binding proteins (CBPs) essential for bacterial cell processes such as cell-wall division, the release of bacterial toxins, and adhesion to infected tissues. The scientists developed a branched molecule to bind CBPs much more strongly than individual choline molecules. When the CBPs are unable to bind to the pneumococci cell walls in the presence of the synthetic branched molecule, the bacteria are unable to separate from one another and form long chains of linked cells, a configuration which halts the damaging release of toxins that occurs with the autolytic end of the pneumococcal life cycle.

4. Africa Regional Pneumococcal Symposium and Meeting of Surveillance Investigators held in South Africa

The Sabin Vaccine Institute, in collaboration with the Pneumococcal Awareness Council of Experts (PACE) and PneumoADIP, hosted the 4th Regional Pneumococcal Symposium in Johannesburg South Africa from March 2-3. Two new studies from PACE were presented at the meeting and highlight the increased risk for children in Africa of contracting pneumococcal disease and suffering its devastating consequences. One review by the group looks at the epidemiologic interaction of sickle cell disease and pneumococcal disease and a second piece reviews information on the long-term sequelae of pneumococcal meningitis. According to PACE, the results reinforce the urgent need for improving access to life-saving vaccines and treatments throughout the continent. The South African Ministry of Health was honored for its leadership in making South Africa the first country in Africa to introduce pneumococcal vaccine.

Later in the week, PneumoADIP, the Hib Initiative and the World Health Organization jointly held the 5th meeting of their international network of surveillance investigators. The meeting brought together nearly 150 researchers, industry representatives and other experts from every region of the world. Discussions included innovative methods in detection and surveillance as well as vaccine impact measurement methodologies.

5. Intercell AG begins Phase I trial of pneumococcal vaccine

Earlier this week, Austrian company Intercell announced that a Phase I clinical trial of their new vaccine candidate against the pneumococcus, IC47, has gotten underway. Three highly conserved surface proteins from Streptococcus pneumoniaemake up the vaccine and have the potential to protect broadly across the more than 90 serotypes of pneumococcus. Intercell's vaccine candidate has been developed through a collaboration with PATH, an international global health nonprofit organization based in the US, under an agreement which sees Intercell providing the vaccine to low-income countries at long-term sustainable prices.


RESEARCH

6. Community-acquired bacteremia is a significant cause of pediatric hospital admission and death in rural Mozambique

According to a study by Sigaúque et al in the Pediatric Infectious Disease Journal, community-acquired bacteremia is an important source of hospital admissions and death among children in rural Mozambique. From 2001 to 2006, researchers systematically analyzed blood cultures among children under 15 years of age admitted to the Manhiça District Hospital in southern Mozambique. Bacteremia was identified in 8% (1,550/19,896) of admitted children. Neonates had a risk of bacteremia nearly four times higher than that of older children. The most common pathogen identified was Nontyphoidal Salmonella (NTS) (26%), followed by pneumococcus (25%). Of the 162 recorded deaths among bacteremic children, pneumococcus was isolated from 27%, NTS from 26%, and H. influenzae from 14%. The authors conclude, "The high incidence rates, antibiotic resistance, and mortality associated with community-acquired bacteremia in Mozambican children underscore the need for prevention. Existing vaccines against Hib and Pneumococcus disease could reduce the incidence of community-acquired bacteremia."

7. Study examines association of pneumococcal serotype with risk of severe or fatal outcomes

In the Pediatric Infectious Disease Journal, Ruckinger et al reported that serotype 7F accounted for a higher risk of severe and fatal outcomes than other serotypes of Streptococcus pneumoniae. The study examined data on 494 children under 16 years of age hospitalized for invasive pneumococcal disease (IPD) in pediatric hospitals in Germany between 1997 and 2003. 17% of the children suffered a severe outcome (including death) with a case fatality rate of 5.3%. Children infected with the 7F pneumococcal serotype had the highest serotype-specific case-fatality rate (14.8%) and the highest rate of severe outcomes (40.7%). When comparing serotype 7 to all other serotypes, the odds ratio was 4.3 for fatal outcome and 4.0 for serious outcomes. These results suggest that the serotype-specific risk for severe or fatal outcome is an important factor in describing the epidemiology of IPD and in optimizing treatment and prevention measures.

8. Impact of routine immunization with 7-valent pneumococcal conjugate vaccine (PCV) reviewed

In a review published in the journal Vaccine, Bechini et al summarize the data available to date in countries routinely immunizing infants with PCV. The authors conclude that the 7-valent PCV showed high efficacy against invasive pneumococcal diseases caused by vaccine serotypes in children under age two. Studies have suggested that indirect population benefit of vaccination outweighs the direct protection conferred on immunized individuals against invasive pneumococcal disease (IPD). A small increase in the incidence of non-vaccine serotype IPD as a proportion of all disease has been observed in some populations, but is far below the overall reduction in absolute cases seen with widespread use of PCV. The authors conclude by comparing detection methods such as PCR and culture-based methods and comment briefly on the status of second generation PCVs currently in the vaccine pipeline.


FINANCE

9. New study shows that many serious diseases are significantly underfunded

Diseases endemic to developing countries are killing millions of people, but remain significantly underfunded, according to a worldwide survey of funding for neglected diseases. Commissioned by the Bill and Melinda Gates Foundation and conducted by researchers from The George Institute in Australia, the study estimated that $2.5 billion was spent globally in 2007 on research and developing drugs for tropical diseases. HIV/AIDS, TB and malaria accounted for 80% of the funding. In contrast, pneumonia and diarrheal diseases collectively received less than 6% of these funds. The authors note that "Investment decisions are not only influenced by scientific or epidemiological considerations, but may also be influenced by factors such as the presence of advocacy and fundraising groups; by funder perceptions or preferences; or by the presence of policy frameworks and funding mechanisms that prioritize specific diseases." The study also revealed that public and philanthropic donors collectively invested 90%, of the total funding.


UPCOMING EVENTS

April 27-29, 2009– The National Foundation for Infectious Disease will hold its Twelfth Annual Conference on Vaccine Research in Baltimore, Maryland. More information can be found by visiting: http://www.nfid.org/conferences/vaccine09/

April 27 – May 1, 2009 – The 12th World Public Health Congress will convene in Istanbul Turkey. Themes addressed at the conference include public health education, policy, and public health practice. For more information: http://www.worldpublichealth2009.org/greetings.html

May 16, 2009 – The 9th International Advanced Course on Vaccinology for the Asia Pacific Region, hosted by the International Vaccine Institute, will be held in Seoul, Korea. The course aims to strengthen the capacity of countries in vaccinology by providing participants with a comprehensive overview of the vaccine continuum, from vaccine development, evaluation and regulatory principles, to production, post-licensure, introduction and policy issues. For more information, please visit: http://www.ivi.int/vaccinology2008/

May 18-27, 2009 – The 62nd World Health Assembly will take place in Geneva, Switzerland. Key items on the agenda to be discussed by Member States include Primary Health Care, the Social Determinants of Health, monitoring of the achievement of the health-related Millennium Development Goals, WHO’s role and responsibilities in health research, and progress reports on a number of technical issues of relevance to child and adolescent health and development. Information about the WHA can be found on: http://www.who.int/child_adolescent_health/news/events/2009/18_05/en/index.html

May 26-30, 2009 – The Annual Global Health Council Conference will take place at the Omni Shoreham Hotel in Washington, DC. The deadline for regular registration is May 1 and on-site registration fees will apply thereafter. This year’s theme is "New technologies + Proven Strategies = Healthy Communities". Please visit: http://www.globalhealth.org/conference_2009/

June 8-11, 2009 - World Vaccine Congress Asia 2009
– to be held in Marina Mandarin, Singapore – will bring together global and regional vaccine buyers and sellers, regulators, investors, technology and service providers to discuss best business strategies in accessing different vaccine markets in Asia and forging strategic partnerships for international success. http://www.terrapinn.com/2009/wvcasia/


ONLINE POLL


Results from online PneumoADIP poll
A PneumoADIP web-based poll surveyed our readers on the question: With 1 million newborns a year, but only enough money for 2 million doses of pneumococcal vaccine per year, what would you recommend? The leading answer was to give three doses to each "high risk" child under age 2 years (35%), followed by give 2 doses to each newborn (25%), give 1 dose to each child <2 years old (25%), and do not vaccine until funding is available to give 3 doses to all newborns (15%). To view the results click here.