This episode of The Vaccine Challenge is hosted by Priyanka Asera and features Derek Wallace. Derek is the VP and Global Dengue Program head at Takeda. Derek has been at Takeda since 2013, but has over 16 years of experience in clinical development, infectious diseases and medical affairs from working at Merck, Novartis and Sanofi Pasteur.
Takeda is on the cusp of having a vaccine for dengue approved - and today we talk about how dengue affects the world, which regions get most hit, what the impact of the vaccine will be in alleviating the threat it presents, what happens behind the scenes to get the vaccine approved, and how does a company plan for execution when there is no clear date estimation of when the approvals are likely to come in. We also talk about whether or not the speed in covid vaccine approvals will have a long lasting impact on all vaccine approvals going forward. For this and more… listen on.
SUMMARY OF THE PODCAST INTERVIEW
Could you share some context on the impacts of dengue world over?
- In 2019, the World Health Organization named dengue, one of its top 10 threats to public health.
- Affects tropical and sub tropical countries across the globe, particularly in Asia & Africa.
- The disease is caused by a virus spread by mosquitoes so it’s a vector borne viral disease.
Describe the pathway to development of this vaccine, that’s now almost on the cusp of approval.
- Takeda have been developing the vaccine since 2013 but its history is much longer than that. Our vaccine is for a serotype that was originally identified back in the 1980s in Thailand and was attenuated by the CDC in USA.
- Some of the early phase work was done by a company called Invitrogen, Takeda took over at the beginning of Phase 2.
- It was a very large scale trial - enrolled 20,000 children aged between 4 and 16, across 8 different dengue endemic countries across Asia and Latin America. The study was 4.5 years long. Then, after 3 years of follow up, we felt in a position to provide the data to regulatory authorities. So we’re currently under review.
Can you explain the approval process in different countries?
- Submitted our file to the European authorities in March 2021. Shortly afterwards, it was submitted to a number of dengue endemic countries.
- European authorities assist in the review of a product that is also under parallel review by the individual countries. So for example, we have Colombia, Argentina, and Brazil, in Latin America that are participating in this process, each of those countries get exactly the same file that Europe gets. And the reviews occur in parallel where the the comments and the questions that come from regulators are shared between the regulators.
- Each individual country will clearly make its own choice, but it strengthens the quality of review. So we're in that process now. And we would expect the CH MP opinion before the end of our fiscal year together, which is before March of 2022.
What happens once the vaccine is approved? Talk to me about the logistics.
- Particularly complicated because we're going to so many countries in parallel. We've prioritised early registrations in places where the vaccine is needed the most. Eg. Argentina, Colombia, Brazil, Philippines, Indonesia, Malaysia, and will be submitting into Thailand, Sri Lanka, Mexico and the US in the coming months.
- We'll also be considered for public programs, which is really what recommending bodies do. Need a plan that's specific to each country, provide as much information as we can on the on the risks and benefits of the vaccine, understand the epidemiology in those particular settings. And essentially, the right recommending bodies will decide how the vaccine should be used for that particular context.
How do you make contingency plans not knowing when exactly the vaccine will get approved?
- We have to make assumptions about how long the regulatory process will take. And so we can have a base case for when we would expect to to launch a vaccine following approval. But of course, that can be faster than we expect or slower than we expect.
- Where it's faster than we expect, the rationale is clearly that there is maybe an ongoing epidemic in that country and a very clear need for an acceleration of review, so then we have a real obligation to make sure the vaccine is is available in an accelerated way.
- This means our supply chain has to be robust, we have to have a lot of scenario planning. We do get a little bit of time, because there are some activities that have to occur prior to launch after approval. There are processes we need for importation for example, that need to occur following approval. And these typically take a couple of months.
- But if we waited to manufacture after approval, we wouldn't be able to supply the kind of demand that we would expect. So we have to make a lot of investments that are essentially at risk. We have been making commercial material for some time now at our contract manufacturer in Germany, essentially building inventory so that we're able to manage sudden spike in demand.
ABOUT DEREK
Derek Wallace, MBBS, is Vice President and Global Dengue Program Head at Takeda. In this role, Mr. Wallace leads the global program team in the development of Takeda’s dengue vaccine candidate (TAK-003). Mr. Wallace joined Takeda in September 2013 as Global Programme Medical Director responsible for the development of TAK-003 as well as Takeda’s enterovirus vaccine candidate.
Mr. Wallace has over 16 years of experience in clinical development, infectious diseases and medical affairs. Prior to joining Takeda, Mr. Wallace held clinical development and medical affairs positions at Merck, Novartis and Sanofi Pasteur. At Sanofi, Mr. Wallace served as clinical team leader for Sanofi’s dengue vaccine candidate, influenza studies and preparations for first-in-human studies of vaccine candidates for malaria and meningitis B. His experience also includes transplant, cardiology and women’s health.
Mr. Wallace holds a Diploma of Vaccinology from the Institut Pasteur and a Diploma in Pharmaceutical Medicine from University of Wales, Cardiff. He received his Bachelor of Medicine, Bachelor of Surgery from the University of Queensland.