PneumoALERT

Bulletin of PneumoACTION, a project of IVAC, at Johns Hopkins Bloomberg School of Public Health

Volume 7, No. 1  January, 2010

DIRECTOR'S NOTE

A decade for vaccines

With the doubling of funding for vaccine research and delivery systems from the Bill & Melinda Gates
Foundation, 2010 ushers in a renewed focus on expanding access to vaccines. The $10 billion pledge from
Gates to make this "the decade of vaccines" is based on estimates that scaling up the delivery of life-saving vaccines in developing countries—particularly pneumococcal and rotavirus vaccines—to 90 percent coverage could prevent nearly 8 million deaths in children under 5 by 2020.

Here at the new International Vaccine Access Center (IVAC) at the Johns Hopkins Bloomberg School of
Public Health we are devoting ourselves to this pursuit. The IVAC was established at the end of 2009 to work strategically, connecting the dots between vaccine-related research, policy and access. By focusing on
carrying out research that will be useful to the policy process, and in helping to support the creation of
policies that will deliver the widest and most equitable vaccine access to children, IVAC builds on the
successful completion of the Hib Initiative and PneumoADIP projects.

With the PneumoACTION Web resource, IVAC will continue to provide the latest evidence and tools—like a downloadable interactive map showing country-by-country pneumococcal disease burden estimates—for advocates, policy makers, donors and other stakeholders about pneumococcal disease and pneumonia. The PneumoACTION newsletter will remain devoted to culling the latest and most pertinent research, news and events on pneumococcal disease and pneumonia. But our mandate has become broader and, we hope, more strategic than ever. For instance, we are using the latest, most rigorous diagnostic tools to determine the etiology of pneumonia in six countries including Bangladesh, South Africa and Mali through the PERCH project.
We are working to test the newest DNA and antigen-based alternatives to bacterial culturing to find practical solutions for laboratories in low-resource settings through a project called LEAP. Others on our team, which includes scientists, economists, policy experts, and advocacy specialists, are taking unusual approaches to solve problems related to expanding vaccine access. One project will assess how to leverage the experience
of consumer goods companies like Coca-Cola to improve delivery of vaccines in remote areas. Other
examples of current projects can be found at our Web page, www.JHSPH.edu/IVAC --look here for more
updates in the months to come.

We hope this expanded mandate will make our resources increasingly useful to our colleagues. We would welcome comments on PneumoACTION and the IVAC. What resource or tool do you use most? What
additional resource could you use? Let us know.  

Cheers to the decade of vaccines!

Orin S. Levine, PhD
Executive Director, PneumoACTION
Johns Hopkins Bloomberg School of Public Health

NEWS

  1. Gates Foundation Commits US$10 Billion to Childhood Immunization
  2. Executive Board of WHO Recommends Adoption of Pneumonia Resolution
  3. WHO prequalifies GSK's PCV-10 for international use
  4. GAVI estimates that its efforts will prevent 4 million premature deaths by the end of 2009
  5. Threat of preventable childhood diseases remains 20 years after ratification of groundbreaking child rights treaty
  6. SAGE urges renewed efforts to reach unvaccinated and undervaccinated children, as well as improved pertussis surveillance and control
  7. Global health experts call on U.S. to donate H1N1 vaccines to developing countries
  8. European regulators approve Pfizer Inc.'s Prevenar 13

RESEARCH

  1. Researchers describe the development, scale-up, and achievements of a national pneumonia program in Malawi
  2. Review of research on pneumococcal pneumonia featured in The Lancet
  3. Researchers use simulation model to compare PCV-7 and PHiD-CV in the UK
  4. Pneumococcus serotype prevalence and drug resistance in Brazil
  5. Effect of PCV-7 on disease incidence and serotype distribution in the U.S. examined
  6. New data on rotavirus vaccine from Mexico and Africa show lifesaving impact and effectiveness in the developing world

ANNOUNCEMENTS

UPCOMING EVENTS

NEWS

1. Gates Foundation Commits US$10 Billion to Childhood Immunization

The Bill and Melinda Gates Foundation announced today  from Davos, Switzerland, the site of the World Economic Forum, that they planned to more than double their spending on childhood immunization to $10 billion over the next ten years. The funds will come from increased annual giving from Mr. Gates and Warren Buffett and will account for about 30% of the Foundation's spending. Mr. Gates cited figures from the Institute for International Programs at Johns Hopkins University estimating this investment could save the lives of nearly 8 million children over the next decade. Investments from the Foundation will support a range of immunization-related programs from vaccine development to delivery, and was hailed by WHO Director-General Margaret Chan as "unprecedented." Partners including the private sector, countries and other donors were called on increase their commitments to lifesaving vaccines for the developing world, ensuring that millions more children will reach their fifth birthday.

2. Executive Board of WHO Recommends Adoption of Pneumonia Resolution

On 22 January, the Executive Board of the World Health Organization (WHO) approved a draft resolution calling on countries, international institutions and the Director General to prioritize the prevention of and treatment of pneumonia, providing funding and resources as well as report on progress in efforts to address child pneumonia as outlined in the WHO/UNICEF Global Action Plan for the Prevention and Control of Pneumonia (GAPP). The World Health Assembly (WHA) will have the opportunity to adopt the resolution at their annual meeting in May. With UNICEF and WHO, the UK government, spurred by the All Party Parliamentary Group (APPG) on Pneumococcal Disease Prevention in the Developing World, helped to promote the resolution.

3. WHO prequalifies GSK's PCV-10 for international use

The World Health Organization recently announced international prequalification of Synflorix, GlaxoSmithKline's 10-valent pneumococcal conjugate vaccine (PCV), which protects against 80% of invasive pneumococcal disease among children under age five. In addition to the strains included in the 7-valent vaccine versions, the 10-valent vaccine includes strains 1, 5 and 7F, which are found more frequently in developing countries. The rigorous prequalification review process  by the WHO ensures that approved vaccines are safe and efficacious, as well as appropriate to program needs. The current endorsement applies to the one-dose vial presentation of the vaccine; an evaluation of the two-dose vial version is underway. WHO prequalification is expected to speed vaccine purchasing ability by UN agencies and increase international access to this life-saving vaccine.

4. GAVI estimates that its efforts will prevent 4 million premature deaths by the end of 2009

GAVI's efforts to accelerate and expand access to pertussis, Hib, and Hepatitis B vaccinations will avert four million child deaths by the end of 2009, according to the organization's recent estimates. At a forum in Vietnam, which brought together over 400 experts from 30 countries, GAVI Board Chair and former UN High Commissioner for Human Rights Mary Robinson announced, "It is time to recognize that the availability of life-saving vaccines for children worldwide, regardless of where they live, is not a luxury but a fundamental right." The forum also highlighted the recent drop in price for the Hib-containing pentavalent vaccine, credited to the purchasing activity of the GAVI Alliance.

5. Threat of preventable childhood diseases remains 20 years after ratification of groundbreaking child rights treaty

Marking the 20th anniversary of the UN adoption of the Convention on the Rights of the Child, UNICEF released a special State of the World's Children report  that highlights progress and ongoing challenges related to child health and well-being. Important milestones include: annual under-five mortality has dropped 28 percent globally; child protection against HIV/AIDS has increased exponentially; and more girls have access to primary school education. However, threats of violence, as well as the toll of pneumonia and other preventable diseases remain serious challenges to continued child mortality reduction. To read the full report, click here, and to view multimedia presentations from advocates and experts in the field, click here.

6. SAGE urges renewed efforts to reach unvaccinated and undervaccinated children, as well as improved pertussis surveillance and control

Conclusions and recommendations from the October 2009 meeting of the Strategic Advisory Group of Experts (SAGE) on immunizations  were recently published in the WHO's Weekly Epidemiologic Record.  The results of a literature review focusing on unvaccinated and undervaccinated children were presented at the meeting, which revealed that many different local-level factors contribute to children being unvaccinated or undervaccinated. These include factors in the immunization system itself like distance of children to vaccination site, as well as demand-side factors like family characteristics and parental attitudes. SAGE recommended that the WHO operationalize the findings of this review to address gaps in immunization coverage, which leave 24 million children each year without routine vaccinations.

SAGE also called on regions to prioritize pertussis surveillance and control, emphasizing the need to monitor on-time coverage of pertussis vaccination. They also acknowledged the challenges of pertussis diagnosis, and recommended that WHO work to develop "demonstration projects" to expand the diagnostic capacity of laboratories in select countries, as well as to link pertussis surveillance to the GAVI Alliance network of laboratories for invasive bacterial disease. SAGE also noted that they support the work of WHO's Child Health Epidemiology Reference Group and the Pneumonia Etiology Research for Child Health project, which will help to quantify the burden of pertussis-related morbidity and mortality in developing countries.

7. Global health experts call on U.S. to donate H1N1 vaccines to developing countries

In a recent editorial, Ruth Karron, Orin Levine and Ruth Faden recommended that the U.S. and other wealthy countries "immediately donate 10 percent of their H1N1 vaccine supply for the poorest countries." There is currently a global shortage of H1N1 vaccine, as experts estimate that only 3 billion doses could be produced over the next year. In the U.S., H1N1 cases are on the decline, while supply and distribution of the vaccine continue to increase. In contrast, many people living in developing countries remain highly vulnerable to H1N1. Further, H1N1 can lead to bacterial infections, only adding to the disproportionate burden of pneumonia among the poor. They conclude that "in this season of giving, we should do what we can now to provide as much vaccine as possible, as quickly as possible, to the people who need it most."

8. European regulators approve Pfizer Inc.'s Prevenar 13

Earlier this month, European regulators approved Pfizer Inc.'s Prevenar 13 vaccine  for use among children age 6 weeks to 5 years. Vaccine trials of more than 7,000 children indicate that Prevenar 13 is safe and effective in preventing pneumococcal disease. Prevenar 13 is designed to protect children from 13 serotypes of pneumococcal, whereas the widely-used Prevenar vaccine protects against 7 serotypes. Emilio Emini, chief scientific officer of vaccine research at Pfizer said, "By providing the broadest serotype coverage of any pneumococcal conjugate vaccine, Prevenar 13 is poised to help reduce the serious public health risk and economic burden associated with pneumococcal disease."


RESEARCH

9. Researchers describe the development, scale-up, and achievements of a national pneumonia program in Malawi

Enarson and colleagues published an overview of the development and implementation of a national program for the management of severe and very severe childhood pneumonia in Malawi  in a recent issue of PLoS Medicine. Based on a successful delivery model used by the International Union Against Tuberculosis and Lung Disease for antituberculosis services, the goal of the program is to improve the management of severe and very severe pneumonia among children admitted to district hospitals in Malawi. The program focused on achieving political commitment from the government and financial support from a donor, training healthcare workers in the standard case management of pneumonia, purchasing and distributing standardized drugs, surveillance and evaluation. From 2000 to 2005, more than 312 healthcare workers participated in training courses as part of the program. During this time, the proportion of children dying from pneumonia dropped 54.8%, from 18.6% to 8.4%. Researchers identified healthcare worker shortage as the major challenge of the program. They conclude that this experience "demonstrates the feasibility and effectiveness of a model programme based on the principles of the successful model for tuberculosis control to reduce case fatality in children hospitalized for pneumonia within first-level referral hospitals."

10. Review of research on pneumococcal pneumonia featured in The Lancet

In the October 31st issue of The Lancet, van der Poll and Opal published a summary of the past 10 years of research on pneumococcal pneumonia. The article includes a review of the epidemiology, genetics and immunology of the disease, as well as approaches to clinical diagnosis, treatment, and vaccination. They conclude that "The capacity of S. pneumoniaeto resist antimicrobial agents and escape immune defenses shows that control of this pathogen will not be easy to achieve. Thus a multifaceted approach with new generation vaccines, novel antimicrobial therapies, and improved adjuvant treatments will be needed." The article accompanied a call for "renewed action against pneumonia," co-authored by US Senate Majority Leader Bill Frist and Richard Sezibera, Rwanda's Minister of Health.

11. Researchers use simulation model to compare PCV-7 and PHiD-CV in the UK

In the October issue of Clinical Therapeutics, researchers used a new simulation model to compare the potential population-level impact of PCV-7 coverage in the UK  with that of the recently-licensed pneumococcal nontypable H. influenzaeprotein D-conjugate vaccine (PHiD-CV) across different vaccination schedules. PHiD-CV is a 10-valent conjugate vaccine for which 8 of the 10 serotypes include a carrier protein derived from nontypable H. influenza. The model predicted that the current PCV-7 regimen (2 doses + 1 booster) would prevent 325 cases of invasive pneumococcal disease (IPD) and 619 pneumonia hospitalizations annually. In contrast, implementation of the PHiD-CV would prevent 375 to 503 cases and 755 to 994 hospitalizations annually, depending on the vaccination schedule (2+1 vs. 3+1). PHiD-CV would also prevent 30,920 to 47,180 general practitioner visits for otitis media, whereas PCV-7 would only prevent 9,016. Including a net indirect effect of 38% in the model resulted in a predicted prevention of 2417, 2451, and 3045 IPD cases with PCV-7 (2+1), PHiD-CV (2+1) and PHiD-CV (3+1), respectively. The authors conclude that the implementation of any of these vaccinations in the UK would have a "striking impact" on IPD cases and hospitalizations, and otitis media outpatient visits. However, the PHiD-CV (3+1) would have a greater impact than PCV-7.

12. Pneumococcus serotype prevalence and drug resistance in Brazil

In the October Issue of the Brazilian Jornal de Pediatria, researchers presented findings from nearly 10 years of data on the serotype prevalence and drug resistance  of pneumococcus in Brazilian children under age five. They analyzed 142 strains of pneumococcus obtained from children admitted to the Hospital de Clínicas of Universidade Federal de Uberlândia, Uberlândia, Brazil for invasive pneumococcal disease from April 1999 to December 2008. They identified 20 different serotypes, 71.9% of which are included in the 7-valent pneumococcal conjugate vaccine. The most common serotypes were 14, 5, 6B, 1, 6A, 18C, 19A, 3, 9V, 19F, 23F, 9N, and 10A. Of all strains, 14 (9.9%) were penicillin-resistant; these resistant strains were found predominantly in the second half of the analysis period, from 2004 to 2008 (p = 0.000). Reduced susceptibility to co-trimoxazole (79.5%), erythromycin and clindamycin (11.3% each), and ceftriaxone (5.6%) was also found.

13. Effect of PCV-7 on disease incidence and serotype distribution in the U.S. examined

Researchers examined IPD cases from 1998 to 2007 from eight sites across the U.S to examine the impact of the PCV-7 introduction. All-age IPD incidence rates decreased by 45% (from 24.4 to 13.5 per 100,000 population, p<.01) while vaccine-type incidence decreased 94% (from 15.5 to 1.0 cases per 100,000 population, p<.01). Among children under five, all-type incidence decreased 76% (from 98.7 to 23.6 per 100,000, p<.01) and vaccine-type incidence decreased 99.5% (from 81.9 to 0.4 per 100,000, p<.01). Researchers found an increase in incidence of non-vaccine serotypes including 19A (from 6.1 to 7.9 per 100,000 across all ages and 6.8 to 10.3 per 100,000 in children under five, p<.05). However, authors note increased rates of IPD caused by serotype non-PCV7 types remain low relative to decreases in PCV7-type IPD. From 2000 to 2007, the introduction of the PCV-7 resulted in an estimated 211,000 fewer cases and 13,000 fewer deaths.

14. New data on rotavirus vaccine from Mexico and Africa show lifesaving impact and effectiveness in the developing world

Findings of significant reductions in rotavirus disease  following immunization with rotavirus vaccine in Mexico and Africa were published by Richardson et al. on January 28th, 2010 in the New England Journal of Medicine.  Mexico was one of the first countries to introduce rotavirus vaccine in 2006. The Mexico study examined the impact of vaccination on diarrheal deaths in Mexican children between 2008 and 2009 following a phased introduction of the orally administered Rotarix™, manufactured by GlaxoSmithKline Biologicals (GSK). During the 2009 rotavirus season, study results showed a 65 percent decline in diarrheal deaths rates in children less than 2 years of age and a 40% decline in infants younger than 11 months.

In South Africa and Malawi, the results of a clinical trial conducted by Mahdi et al. showed that the vaccine significantly reduced severe rotavirus disease—by 61.2 percent—in African infants during the first year of life. The African clinical trial specifically focused on the vaccine’s performance among infants in high mortality, low income settings. More than 4,900 infants were enrolled in a clinical trial examining the efficacy of the Rotarix™ vaccine.


ANNOUNCEMENTS

International Research in Infectious Diseases Including AIDS (IRIDA) Program (R01) - National Institute of Allergy and Infectious Diseases (NIAID): This funding opportunity announcement (FOA) issued by the NIAID solicits Research Grant (R01) applications from organizations/institutions in eligible foreign countries that propose research related to infectious diseases that are of interest to that country. Details available at http://grants1.nih.gov/grants/guide/pa-files/PAR-08-130.html.


UPCOMING EVENTS

February 1-3, 2010, the 2010 Annual Conference on Antimicrobial Resistancewill be held in Bethesda, Maryland. For conference details, visit http://www.nfid.org/conferences/resistance10/.

The 14th International Congress on Infectious Diseaseswill be held March 9-12, 2010 in Miami, Florida. Visit the conference website at http://www.isid.org/14th_icid/  for more information.

The 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-7)will take place in Tel Aviv, Israel March 14-18, 2010. Conference details are online at http://www2.kenes.com/isppd/pages/home.aspx  Visa applications for travel to Israel may be a lengthy process, so participants are advised to register and begin the Visa application process as early as possible.

The Global Health Council's 37th Annual International Conference on Global Health, Dateline 2010: Global Health Goals & Metrics, will take place in Washington D.C. June 10-14, 2010. Additional information on this conference, which will examine metrics, progress and challenges on global health goals, is available at http://www.globalhealth.org/conference_2010/

July 11-14, 2010, the International Conference on Emerging Infectious Diseaseswill be held in Atlanta, Georgia. Visit http://www.iceid.org/  for additional information about the conference. The general abstract submission deadline is March 1, 2010.