IVI in the Media
Challenges in MenB vaccine development
In an editorial published in The New England Journal of Medicine, IVI Director General Jerome Kim looks at the challenges and possible solutions
In a recent issue of The New England Journal of Medicine, IVI Director General Jerome Kim considers an accelerated pathway for vaccine approval. Dr. Kim’s editorial follows the publication of a research article in the same journal regarding the immunogenicity study of a meningococcal B vaccine (4CMenB) used during an outbreak of Neisseria meningitides serogroup B at a U.S. university.
Regulatory approval and clinical use of vaccines for pathogens causing outbreaks has always been challenging. In the case of MenB vaccines, proving clinical efficacy has been difficult due to the substantial genetic diversity of the pathogen and the decline of meningococcal disease in countries where the burden is well understood. Yet there have been several outbreaks at U.S. universities from 2009-’15 resulting in 43 cases and 3 deaths. Since no MenB vaccine was approved at the time of the outbreaks, chemoprophylaxis was the main intervention. Therefore, a U.S. university outbreak of serogroup B meningococcal disease presented an opportunity to test a multicomponent meningococcal serogroup B vaccine (4CMenB) that had been approved in Europe and Canada on the basis of laboratory biomarkers of efficacy. There was also evidence that the vaccine could provide protection against the outbreak strain.
The study showed that 4CMenB induced a response to certain MenB strains but induced a lower response rate against the outbreak strain in the vaccinated students. While it is difficult to conclude if vaccination had a positive effect on the outbreak, the vaccine did induce bactericidal antibodies against the outbreak strain and was safe.
Based on these findings, 4CMenB and another MenB vaccine (MenB-FHbp) were approved by the U.S. FDA in 2015 through an accelerated approval process intended for treatments for serious or life-threatening diseases. The vaccines were approved for use in persons 10-25 years old with the caveat that post-marketing studies be conducted to confirm effectiveness against MenB strains endemic in the U.S..
With this case study in mind, Dr. Kim’s editorial points out that for a relatively uncommon but life-threatening disease such as MenB, the regulatory approval of a vaccine in the absence of ideal data may be necessary and appropriate if the vaccine is used in the context of a public health response and if there is commitment to generating additional data for its use. More importantly, he argues the accelerated pathway for product approval should extend to vaccines against pandemic threats and limited outbreaks (e.g., Zika virus, MERS-CoV). By doing so, this could help accelerate emergency R&D to prevent or mitigate the impact of infectious disease outbreaks, ultimately saving lives and minimizing socioeconomic disruption.
Read it here:http://www.nejm.org/doi/pdf/10.1056/NEJMe1606015