Realising the potential of correlates of protection for vaccine development, licensure and use: short summary
Deborah King, Helen Groves, Charlie Weller, Ian Jones, Jakob P. Cramer, Peter B Gilbert, David Goldblatt, Marion F. Gruber, Beate Kampmann, Diadié Maïga, Marcela F Pasetti, Stanley A. Plotkin, Alexander Roberto Precioso, Liya Wassie, Frederick Wittke, David C. Kaslow
Abstract
Vaccines have had a significant impact on global morbidity and mortality over the last century, with estimates indicating that millions of lives are saved each year as a result of vaccination 1 , 2 . There are over 30 vaccine preventable diseases including those that contribute significantly to childhood mortality such as measles, but new vaccines are needed for diseases such as tuberculosis (TB), HIV, and emerging infectious diseases such as Sudan Ebolavirus, and Lassa virus. Vaccine development, particularly late-stage development is costly, time-consuming and is associated with high risk of candidate failure, with as few as 10% of vaccine candidates achieving licensure after launch of phase 2 trials 3 , 4 . An average vaccine candidate takes 10 years and costs $500 m to develop 5 , 6 , 7 . The high level of investment needed to progress vaccine candidates through late-stage development combined with high risk of failure can disincentivize development of products, especially where there is limited or unknown commercial market, which is the case for many diseases that affect LMIC’s 8 or when products do not have a clear pathway to demonstrate efficacy.