Washington , DC - March 25, 2005 .  The sponsors of the Gambia Pneumococcal Vaccine Trial, with support from PneumoADIP’s Communications group, were able to generate tremendous media coverage of the exciting results.  The sponsors used press releases, media outreach, and a press conference at the National Press Club in Washington , DC to inform the public about the findings of the trial.  Media coverage exceeded anyone’s expectations; stories appeared in hundreds of newspapers and websites and on TV stations around the world.  Congratulations to all of those who worked so hard to make this important trial a success and especially to Professor Felicity Cutts, lead author of the study. The results of The Gambia Pneumococcal Vaccine Trial are now available in the March 26, 2005 issue of The Lancet.

GAVI’s PneumoADIP is pleased to announce the second round of recipients of our Small Grants Program awards.  All submitted applications were reviewed first internally and then externally for scientific merit, methodological soundness, and agreement with PneumoADIP’s mission - to improve child survival and health by accelerating the evaluation of and access to new, lifesaving pneumococcal vaccines for the world's children. Congratulations to the successful candidates!

Sindh , Pakistan . Researchers at Aga Khan University (AKU) will work to determine the burden of pneumococcal disease while strengthening the existing surveillance system in southern Pakistan .  From March 2005 to June 2006, AKU will be responsible for establishing and supporting 15-20 study sites chosen from public and private sector hospitals in Karachi and Hyderabad , the two largest cities of the Sindh region in southern Pakistan .  Several laboratories in the private sector will also be included in the surveillance network.  The primary disease burden objectives are to determine the regional prevalence and serotype distribution of pneumococcal meningitis in children less than 5 years of age.

Kinshasa , Congo .   From February 2005 to August 2006, Kinshasa School of Public Health will establish and support study sites at four hospitals as a pilot study of pneumococcal disease burden for a larger prospective cohort study of hematogenous and invasive cerebrospinal disease burden.  The pilot study will estimate the national burden of pneumococcal meningitis among children by measuring local disease prevalence, serotype distribution, and antimicrobial resistance levels among pediatric cases in the Kinshasa district.

Bobo-Dioulasso , Burkina Faso .   GAVI’s PnuemoADIP is proud to continue its support to the surveillance team headed by Jean-Francois Aguilera and Brad Gessner of Association for l’aide à la Médicine Préventive.  Their second PneumoADIP Small Grant will fund the collection of blood cultures from all inpatient pneumonia cases at the national hospital from April 2005 through October 2006.  This specimen collection is part of the on-going integrated efforts to assess the disease burden of pneumonia in Burkina Faso and to build laboratory and surveillance capacity of the local sites.

In recognition of the difficult decisions manufacturers and government regulatory agencies face in developing and evaluating second generation pneumococcal conjugate vaccines (PCVs), the World Health Organization has published its official recommendations for the production and control of PCVs. The publication of these recommendations represent a major step forward in assuring a steady supply of safe, quality vaccines for the world. While not a legally binding set of guidelines, the recommendations are the result of meetings of the WHO Expert Committee on Biological Standardization involving representatives from academia, regulatory authorities, and industry and are highly influential. One expected impact of the document will be to improve the clarity for vaccine manufacturers regarding the regulatory pathway for licensure, which in turn should be a big stimulus to vaccine research on improved pneumococcal conjugate vaccines. The document is now available here in draft form and will also be published in print as part of the WHO Technical Report Series.

In the August 2004 issue of PneumoFOCUS , we highlighted findings of the 9-valent pneumococcal conjugate vaccine (PCV) efficacy trial in Soweto , South Africa . PneumoADIP sponsored a follow-up study of the Soweto trial, and Shabir Madhi and colleagues reported their latest findings in PLoS Medicine (February, 2005) . The authors performed procalcitonin and C-reactive protein (CRP) assays on the collected blood samples and re-analyzed the efficacy of PCV against pneumococcal pneumonia based on both the serologic and chest X-ray (CXR) confirmations. The authors report that PCV efficacy studies relying solely on CXR diagnosis underestimate the true efficacy of PCV. For a more accurate picture, the authors recommend coupling CXR and serologic markers to increase the specificity of confirmed pneumococcal pneumonia cases. The additional cost of serologic assays to increase specificity allows for a smaller sample size.

Vancouver , Canada - March 22, 2005 . ID Biomedical Corporation announced that after receiving very promising results from the adult and toddler Phase 1 studies of its Pneumococcal Group-Common Vaccine (PGCvax ™) it will proceed with a Phase 1 study of the vaccine in infants. This innovative protein-based vaccine (PPV) is designed to induce an immune response specifically targeting two cell-surface proteins found on all 90 known pneumococcal serotypes. Results of the first Phase 1 study were very encouraging: 92% of young adults and 85% of elderly vaccinated had significant antibody responses to the protein antigen in the vaccine as compared to 0% of controls. In addition they indirectly demonstrated the protection of PGCvax™ against pneumococcal disease; mice injected with antibodies from vaccinated persons were protected from invasive pneumococcal disease.

A look at adult pneumococcal vaccines over the last century shows that past problems parallel issues surrounding childhood pneumococcal vaccines today. A 1963 TIME Magazine article about pneumococcal vaccines for the elderly demonstrates that the situation we face today – questions regarding the burden of pneumococcal disease and market demand – are not so different from those of past decades.

According to Dr. Powel Kanzanjiian of the University of Michigan Medical Center, interest in pneumococcal vaccines first arose over a hundred years ago during an epidemic among South African gold miners when ethylhydrocupreine – then regarded as a potential treatment – proved to be toxic. Then came penicillin. Touted as “the magic bullet,” the effectiveness of antibiotics lowered demand for a pneumococcal vaccine to the point where the manufacturer had to take the product off the market. Now, with the emergence of antibiotic-resistant strains of pneumonia in the past two decades, interest in pneumococcal vaccines has been renewed, especially for at-risk populations: children, the elderly and immuno-compromised patients.

The full historical account by Dr. Powel Kazanjiian is available in J Hist Med Allied Sci. 2004 Oct; 59(4):555-87.