Data from a pivotal trial and three other Phase 3 studies indicate that Wyeth’s investigational 13-valent pneumococcal conjugate vaccine (PCV13) may offer broader protection against pneumococcal disease (PD) in infants and young children compared to Pneumococcal 7-valent conjugate vaccine (PCV7).
Specifically, the data indicate that PCV13 may be as effective as PCV7 in helping to prevent invasive pneumococcal disease (IPD) caused by the seven serotypes shared by the vaccines, and provides expanded coverage for six additional serotypes associated with invasive PD.
The data were presented at the joint annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA) in Washington, DC.
“Pneumococcal disease is a leading cause of meningitis and childhood pneumonia in the UK. Both of these are serious illnesses, and meningitis in particular is associated with high levels of mortality and also significant disability in those who survive”, said Dr Matthew Snape, Consultant in Vaccinology, Honorary Consultant Paediatrician, Oxford Vaccine Group.
“The current vaccine, PCV7, has significantly reduced the burden of pneumococcal disease in the UK but there are many other disease-causing serotypes not covered by this vaccine. The study we have conducted with PCV13 looks very promising and suggests that PCV13 has the potential to broaden protection to other serotypes associated with serious disease, further reducing the impact of pneumococcal disease in the UK.”
Regulatory filing for the new vaccine in the EU is expected during 2009. The 13-valent candidate vaccine is also being studied in global Phase 3 clinical trials in adults, with regulatory filings expected in 2010.
Before the introduction of the pneumococcal vaccine into the UK childhood immunisation schedule, pneumococcal infection killed a child every week and many more were left disabled.
Pneumococcal meningitis is still among the most destructive diseases in terms of death and permanent disability – one child out of every six who contracts pneumococcal meningitis will die, while half of those who survive will be left with some level of disability, ranging from brain damage to deafness.