Mahoney 3rd Wvc Dengue Regulation V2
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1) Development of dengue vaccines requires addressing regulatory issues like evaluating efficacy against the four virus serotypes and safety regarding antibody-dependent enhancement. 2) Clinical trials are most likely to occur first in developing countries with dengue, where discussions among regulators can define the approval pathway with WHO's guidance. 3) It is important to standardize diagnostic tests and identify a correlate of protection to help evaluate vaccines.
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This document summarizes information about ELS Universal English College in Sydney, Australia. It is a leading English language school established in 1988 with experienced teachers. It offers general English, academic English, exam preparation, and junior programs to students from around the world. The school has a central city location, excellent facilities, and pathways to further study. It aims to improve students' English skills while also providing a great study abroad experience.
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- 1. Development of dengue vaccines: A global perspective on regulatory issues Richard Mahoney PhD Director Vaccine Access Pediatric Dengue Vaccine Initiative International Vaccine Institute Seoul, Korea
- 13. Thank you.
Editor's Notes
- Last meeting was November 2007
- According to the list of participants, the invited countries that attended were: Cambodia, Vietnam, Singapore and Philippines), plus FDA and EMEA. Nobody attended from Malaysia.
- Butantan was not there
- I could not find any reference in the meeting reports regarding submission to EMEA. Besides, it is not clear how the Opinion could facilitate the review process by Developing countries. For the second bullet, there is a mix of clinical trial authorization (yellow) which is correct, and evaluation of license application. I would eliminate the first bullet altogether and the second part of the second bullet should be separate "NRAS would need to have the necessary expertise for review Quality , Safety and Efficacy (you forgot efficacy)……
- I am not so sure that registration will occur first in developing countries. I think that for Sanofi, it may be scientific opinion. Also, you have to take into consideration that the registration by a developing country NRA that is not functional would not be supported. And, if the vaccine is intended for prequalification, definitely the country that issues the first license must be functional or it will not be accepted. In general, I think all these points should not under the POLICY title. It is a very sensitive slide. If you want we can discuss on the phone next week.