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. 4 June/July 2009

Director's Note:


Dear Colleagues,

At the halfway point of 2009, it is safe to say that thus far it has been a year of great progress and changes, as you've seen from earlier editions of the PneumoFOCUS. This edition is no exception. We visited Rwanda in April to witness the rollout of pneumococcal conjugate vaccine there and just last week the Ministry of Health announced that vaccine has now reached every district in the country. What happens in Rwanda may be far off but in fact you can show your support with only a few minutes of your time by posting a supportive comment on a recent New York Times blog on the subject (see story below).


From a research perspective, June has been a rich month with new reports of a PCV efficacy trial in Asia as well as a new meta-analysis of pneumococcal conjugate vaccine efficacy, an investigation of carriage in children who participated in a previous trial of PCV-9 and some interesting new work on cost-effectiveness of pneumonia interventions from right here at Hopkins. Our finance section highlights a study of public health financing and an important contribution to the GAVI alliance from the USAID.

 

Best wishes,


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

Media:

  1. GlaxoSmithKline opens plant in Singapore to manufacture pneumococcal conjugate vaccines
  2. International Day of the African Child Commemorated
  3. Pneumococcal vaccine program projected to save thousands of children in Rwanda each year

Research:

  1. Large-scale efficacy trial of the pneumococcal conjugate vaccine conducted in Asia
  2. Efficacy of pneumococcal vaccination in children younger than 24 months: a meta-analysis
  3. Nasopharyngeal carriage of Streptococcus pneumoniae in Gambian children who received pneumococcal conjugate vaccine
  4. Researchers find that simple, cost-effective measures could reduce pneumonia deaths by ninety percent

Finance:

  1. Study reveals quadrupling of global health financing from 1990 to 2007
  2. USAID pledges $75 million towards GAVI immunization effort

Announcements:

  1. Advocacy Associate Position at Johns Hopkins

Upcoming Events:

 

MEDIA

1. GlaxoSmithKline opens plant in Singapore to manufacture pneumococcal conjugate vaccines

On June 9th, pharmaceutical manufacturer GlaxoSmithKline (GSK) opened a new plant in Singapore, which will be used to manufacturer its pneumococcal conjugate vaccine (PCV), Synflorix. The 10-valent vaccine is formulated to add protection against serotypes 1, 5 and 7F to the serotypes in the currently available 7-valent vaccine manufactured by Wyeth. The 85,000 square meter plant is GSK's second global PCV manufacturing site, with one existing plant in Belgium, and cost $411 million to construct. GSK predicts it will begin commercial PCV manufacturing in 2011, following one to two years of testing the production processes. Andrew Witty, CEO for GSK described vaccines as "a potential important product line for the emerging markets and Asia."

2. International Day of the African Child Commemorated

On June 16th, children and their advocates marked the International Day of the African Child with activities in Africa and around the world. The Day is commemorated annually on the anniversary of the 1976 Soweto riots, in which many South African children were injured and killed as they protested for improved education. This year's theme was "Africa Fit for Children: A Call for Accelerated Action Towards Child Survival." UNICEF Executive Director Ann M. Veneman said "It is possible to meet the challenge of helping many more African children survive. The progress that has been made is measured in young lives, and more children can be saved by urgent collective action to scale up existing programmes that have proven successful."

3. Pneumococcal vaccine program projected to save thousands of children in Rwanda each year

As reported in an April PneumoALERT, on April 25, Rwanda introduced the pneumococcal conjugate vaccine (PCV) into its national immunization program, enabling all Rwandan infants to receive the vaccine free of charge. In a recent New York Times online blog on this topic, Nicholas Kristoff blog contributor Josh Ruxin remarked "This is not just good news; it must count as a major development in global public health." Rwanda has gained access to the vaccine approximately nine years after counterparts in industrialized countries, an acceleration of the traditional 12-15 year timeline for most vaccines to reach developed countries. Ruxin concludes that this is an example of how "innovative approaches, undertaken in partnership by governments, industry and non-governmental organizations, can accelerate the spread of life-saving products, processes and intellectual capital to significantly improve health in the developing world." Readers of the PneumoFOCUS can visit Ruxin's blog and post comments.

Meanwhile, a mere two months after beginning the rollout of pneumococcal conjugate vaccine, the Rwandan Ministry of Health has announced that vaccine is now available in every district, countrywide.


RESEARCH

4. Large-scale efficacy trial of the pneumococcal conjugate vaccine conducted in Asia

The results of an efficacy trial for an 11-valent pneumococcal conjugate vaccine (PCV) - the first PCV trial  in Asia - were published in the June 28th issue of Pediatric Infectious Disease Journal. 
The randomized, double-blind, placebo-controlled trial, called the ARIVAC study, was conducted in Bohol, the Philippines from 2000 to 2004 by Lucero and colleagues. The primary outcome of the trial was radiographically defined pneumonia; the trial was not powered for an invasive pneumococcal disease outcome.  A total of 12,191 children age six weeks to six months were
randomly assigned to receive either three doses of an 11-valent PCV or placebo.  By per protocol analysis, there were 93 cases of community-acquired, x-ray confirmed pneumonia among children under two years of age who received PCV11, compared to 120 cases among those who received placebo (vaccine efficacy = 22.9%, 95% CI -1.1 to 41.2; P=0.06).  Similarly, by intention to treat analysis, vaccine efficacy was 16.0% overall (95% CI -7.3 to 34.2). There was no significant difference in the rate of clinical pneumonia between the two groups.  This study is the first of its kind to confirm that in Asia, as in the U.S. and Africa, approximately one-fifth of radiologically-confirmed pneumonia can be prevented with PCV use.

In an accompanying commentary
, Dr. Katherine O'Brien notes the remarkable consistency  of the per-protocol efficacy of PCV against radiographic pneumonia in this trial (in children under two years of age) with that found across settings as diverse as California, South Africa and the Gambia. The Philippines is "a middle income country with relatively low infant mortality, little HIV infection and no malaria". These efficacy findings indicate that regardless of whether we are talking about children in high mortality or low mortality settings, whether they are in Africa, Asia, or North America, at least a third, and in some of these settings probably more than 50% of radiographic pneumonia is caused by pneumococcus (in the setting of Hib vaccine use), writes Dr. O'Brien. Sanofi Pasteur, manufacturer of the investigational 11-valent vaccine used in the study, has since abandoned plans to develop and license the vaccine, citing, in part, concerns about the immunogenicity criteria for licensure. 

5. Efficacy of pneumococcal vaccination in children younger than 24 months: a meta-analysis

In the most recent issue of Pediatrics, Italian researchers report on the results of a meta-analysis of clinical trial data published between 2000 and 2008 focusing on the efficacy of 7,9 and 11-valent pneumococcal conjugate vaccines against invasive pneumococcal disease (IPD), pneumonia and acute otitis media (AOM). Among the analysis' inclusion criteria for individual studies were randomization, focus on patients younger than 24 months of age and administration of 3-4 doses of vaccine before the age of 12 months, resulting in the inclusion of 9 studies. The majority of studies were conducted in the US with others from Finland, South Africa, The Gambia and the Czech and Slovak Republics. Pavia and colleagues found the overall efficacy (across 4 studies) of PCV7to be 89% (95% CI 73-96%, P<0.001) against vaccine-type invasive disease and ranged from 63-74% against all serotypes (per protocol versus intent to treat analysis). PCV7 was found to prevent more than half of the vaccine-type episodes of otitis media, while an analysis of PCV7 and 9 together found a significant level of protection against clinical and radiologic pneumonia (6% and 29%, respectively, in intent-to-treat analysis).

6. Nasopharyngeal carriage of Streptococcus pneumoniae in Gambian children who received pneumococcal conjugate vaccine

Cheung et al report in a recent edition of the Pediatric Infectious Disease Journal on a longitudinal study of the pneumococcal nasopharyngeal carriage of young children who participated in a randomized placebo controlled trial of a 3-dose course of PCV-9 immunization in The Gambia. Researchers found that although the overall prevalence of pneumococcal carriage was high in both the vaccinated and unvaccinated groups in the follow-up study, children who had received vaccine during the original trial of PCV-9 had a risk ratio of 0.56 (95% CI 0.49-0.65) of carrying vaccine serotypes than children who received placebo. The size of the carriage study group allowed for analysis of specific serotypes and findings included a significant decrease in carriage of vaccine-type 6B at 12 and 22 months of age, as well as a significant decrease in carriage of vaccine-associated type 6A at 22 months among vaccinees. Younger siblings of study participants were found to have no significant differences in carriage of VT and NVT pneumococci.

7. Researchers find that simple, cost-effective measures could reduce pneumonia deaths by ninety percent

A study led by the Johns Hopkins Bloomberg School of Public Health, in collaboration with the World Health Organization (WHO) and other public health schools, examined the cost-effectiveness of strategies to reduce worldwide pneumonia-related deaths, and total child mortality. They concluded that implementing a combined strategy to improve nutrition, reduce indoor air pollution, expand immunization coverage, and improve management of pneumonia cases could reduce pneumonia-related deaths by 90% and total child mortality by 17%. Published in the June 2009 issue of the Bulletin of the World Health Organization, the study suggests that the most cost-effective measures to prevent and control pneumonia-related mortality are improvement in community-based treatment of pneumonia, promotion of exclusive breastfeeding, expanded zinc supplementation, and increased Hib and pneumococcal vaccination. "The interventions we examined already exist, but are not fully implemented in the developing world… Fully funding and implementing these interventions could bring us a big step closer towards reaching the U.N. Millennium Development Goals" explained Louis Niessen, MD, PhD, lead author of the study.


FINANCE

8. Study reveals quadrupling of global health financing from 1990 to 2007

In a recent article in The Lancet, Ravishankar and colleagues described the results of the first-ever comprehensive assessment of development assistance for health (DAH) from 1990 to 2007. The researchers used several different sources to estimate DAH, which was defined as all finances from public and private institutions intended to provide health-related development assistance to low- and middle-income countries. They found that DAH increased from $5.6 billion in 1990 to $21.8 billion in 2007, largely due to increased donations from the U.S. government and U.S.-based private charities. HIV/AIDS received a large portion of these funds - an estimated 23 cents of every dollar for DAH. The proportion of dollars channeled through the United Nations and development banks decreased during this time period, while an increasing share flowed through the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Global Alliance for Vaccines and Immunization (GAVI), and non-governmental organizations. The researchers also concluded that, overall, poorer countries are more likely to receive donations than wealthier countries. However, the study revealed some striking anomalies in terms of resource allocation, as 12 of the 30 countries with the greatest burden of illness and premature death did not receive as much assistance as healthier countries.

9. USAID pledges $75 million towards GAVI immunization efforts

The U.S. Agency for International Development (USAID) recently announced plans to contribute $75 million to the GAVI Alliance, supporting efforts to increase access to immunizations in poor countries. Deputy Secretary of State Jacob Lew, who announced the contribution at the GAVI Alliance Board of Directors Meeting, said, "Ensuring better health for the world's children is an investment in the prospects of the next generation." This donation is part of a U.S.-led, six-year, $63 billion global health initiative launched in May of this year. The $75 million pledge is the highest U.S. annual contribution to GAVI to date, bringing the total to $569 million. Dr. Julian Lob-Levyt, GAVI Chief Executive Officer, said, "Even during this economic crisis we cannot stray from the goal of providing children in poor countries with the vaccines we use to protect our own children. If we do this, our legacy will be a healthier, safer more prosperous world for us all."


ANNOUNCEMENTS

10.  Advocacy Associate Position at Johns Hopkins

The Accelerated Vaccine Initiative Technical Assistance Consortium (AVI TAC) is a GAVI Alliance supported initiative with teams based at Johns Hopkins Bloomberg School of Public Health (JHSPH), PATH and the CDC. The primary goal of this effort is to support the accelerated introduction of vaccines against pneumococcal and rotavirus disease into the routine immunization practices of 72 low-income countries. This research associate (faculty) position is part of the Advocacy and Communications team based at JHSPH. For more information, please download the full description and application guidelines by visiting: http://www.preventpneumo.org/Careers.cfm


UPCOMING EVENTS


The 7th World Congress on Health Economics: Harmonizing Health and Economics will take place in Beijing, China on July 12-15, 2009. Information on registration, schedule and accomodations is available at http://www.healtheconomics.org/congress/2009/

The Lancet Conference on Influenza in the Asia-Pacific will be held August 21-23, 2009 in Qingdao, China. Visit http://www.asiaflu.thelancetconferences.com/ for more information about the conference.

On October 4-6, 2009, the 3rd Vaccine Global Congress will take in Singapore. The Congress is sponsored and hosted by the journal Vaccine, in collaboration with the International Society for Vaccines. Additional information about the event is available at http://www.vaccinecongress.com/