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From Measles to Malaria-Case for Building Delivery into Development for Vaccines & Drugs

It falls to me to be the last speaker but it also falls to me to talk about in this clinical development track. One thing which we haven’t really talked enough about, and if there’s a number of alternative delivery partners that are here, but it’s about delivery and building delivery into the whole development process.

I am from a company I work now as the Chief Global Health officer for ApiJect which is a startup company that just started just pre-COVID. I was working with the U.S Government based in Stamford Connecticut, but also with offices in Geneva where I’m based and partners working in South Carolina and in France to develop options for Innovative clinical, innovative delivery for drugs and vaccines. We’re actively we’re developing partnerships now so that’s one of the reasons we’re here we’d love to talk to other partners interested in Innovative delivery platforms that we have.

I was director of Service Delivery for a decade and a half at WHO, worked at U.S. Department of Health and Human Services at the U.S agency for International Development in over 70 countries worldwide. My passion is around ensuring access for people everywhere in all countries and that’s what I worked on for about three or four decades.

If you consider the industry we’re now in and the one we’re here to talk about, it’s the world that vaccine Congress it’s not the world vaccination congress and I think that’s one thing that I think came out a little bit in this morning’s panel, been woven through the discussions, but I just wanted to take a a few minutes to talk about that aspect of delivery in the whole clinical development process.

As an industry, we’re doing a magnificent job on clinical development. In general lots of issues that have been talked about today that we’re trying to overcome but there are more drugs more that are more efficacious and we’re having a bigger impact particularly with vaccines but way too often we can’t deliver those. Two years ago, this might surprise some of you to know, that WHO, which for decades has been talking about access to health care came out at the World Health Assembly and said that more people die from poorly delivered care and poor-quality care then die from lack of access to care. The problem is in general we’ve had a mindset of sort of build it and they will come. Just sort of whatever we sort of make is good enough because it’s better than anything that’s out there particularly in very low resource settings. We have to do a lot better than that. I think COVID put a bright light on that but we have a phenomenon of 20% of the world’s children getting zero vaccines. It’s what we call indeed UNICEF, WHO, the zero dose children and those zero dose children are probably also zero service families.

So we have a Last Mile that we’re not reaching and even the language we talk about with last mile is sort of crazy because the last mile to those communities that’s actually the first mile it’s not the last mile. So we need to really rethink how we get into this and to put sort the delivery questions in our clinical development work.

I think there’s some good news which I wanted to come to but I’ll take a few examples just to show. Measles one number, 25 million, that is the number of children in the last two years that missed vaccinations. We have a massive problem even as we’re trying to envision the next step on COVID and booster shots and handing it over to an influenza program and this kind of stuff. We still have a massive catch-up problem for children globally of 25 million kids having missed. That leaves a lot of them exposed to risk from measles which is the number one worry that we have in a global vaccination problems. So even though that’s was brought about by COVID in 2019 we actually had 200,000 deaths globally from measles. So this is a peacetime problem of delivery for a vaccine that we’ve had for three decades. Measles itself it’s really the complications as many of you know that kill children in terms of pneumonia, the diarrhea, the brain damage that can ensue and while majority of measles deaths that’s true are in the developing World outbreaks have been occurring in many of the countries that we all come from.

Close to where our offices are four years ago, major outbreak in Rockland County, New York of measles. In Europe, half the countries have not met the 95% Target needed to maintain appropriate immunity levels. Numerous countries are basically designated as continuous transmission so I’ll come back to this at the end in terms of the delivery challenges. You can see here some of the measles cases in the U.S and the Skyrocket we had just as we hit COVID.

Monkey Pox which, thanks to Shelly for mentioning that also, is an extremely interesting case of where development meets the delivery. I don’t know. No one else in the room has to agree with me on this but I was a sort of confused by the a lot of criticism that the U.S Government in some cases, but other governments, WHO and others, took for not being more ready with vaccines for monkey pox but for years this has been a disease that that at least WHO has tracked in West Africa. It’s endemic in West Africa and as we might imagine that not so much work went into putting a vaccine together for that but we did manage to approve the JYNNEOS vaccine for monkey pox.

There is a stockpile of the AKM 2000 that is for smallpox that that can be used but these shortages that we had prompted this discussion about fractional Doses and alternative delivery around intradermal but having had numerous discussions with some of the academic centers that have been involved in that testing. For instance one academic lead at an academic center that’ll remain nameless because I didn’t ask her permission to talk about it in this talk. They had several tens of senior nurses involved in some of the clinical trials on the intradermal testing and really two of them only two could reliably produce a bleb when they had to do. As many of you know this is not the easiest injection, it’s taught in Med schools. You don’t use it very often and creating a bleb is essential in order to make sure that the vaccine is going to work and even in the trial itself with senior nurses there wasn’t that reaction. So the idea that we’re going to deploy the JYNNEOS vaccine at scale around the world for intradermal administration without thinking of innovative delivery ways of intradermally administering a vaccine seems maybe a little bit of magical thinking.

My last example is around malaria is highly prevalent around the world, 250 million cases a year and over 625,000 deaths annually. We have been working on vaccines for a long time. It’s difficult because of the vector and the parasite but two promising new vaccines, the RTS/S, that has a schedule of four doses for children from five months of age for reducing malaria disease and burden had a lot of. Just this past year, last October actually, I had a lot of positive news about a lot of discussion about that. At the World Health Assembly in Geneva. We also have R21 which is a sort of another Advance on the similar technology that looks like could have an impact the real world experience is showing us, actually for those of you who followed it, that

efficacy dips to about 40-50% after time and that this effectiveness is really not what we were hoping for or shooting for, but that not unlike the mRNA and see the considerations on seasonal vaccination and the numerous boosting for COVID, the idea of a seasonal administration for malaria. Some of you are well familiar with this, but at least in the Sahel region where I worked for years, it’s mostly a seasonal disease in terms of the following the rainy season. So administering the booster shots seasonally could be useful but at the moment there is no seasonal booster program. There are catch-up campaigns that happen, so the idea that that all the at-risk children are going to come to health centers on an annual basis to be protected after, and this is after the childhood vaccination schedules, there is a big logistical problem. So looking at ways that we can deliver vaccines using community health workers, using more mobile deployment techniques is going to be essential. It’s one that we haven’t solved and every program officer I know that works on malaria that’s thinking about this idea of seasonal application of a malaria vaccine is really scratching their head about what’s going to how that’s going to move forward.

If I can just finish with a couple of thoughts on COVID and what’s next. Two aspects here. Firstly the production in terms of what we’ve learned from synthetic biology and potential for the current tools there’s great promise but there’s also significant worry that this creates the opportunity for Bio threats and other options. It’s basically showed us that there’s, for both outbreaks and for biosecurity, there’s a massive need for fast reaction. We have done a decent job about speeding up and we’ve heard it in this morning. We’ve heard in some of the clinical development sessions here about speeding up that time from sequencing to development to thinking about deployment we have done.

A tiny fraction of that investment has gone to the innovations in deployment so actually getting those vaccines into arms. Supply chain traceability causes a problem and the potential for disease to spread very quickly. Actually this right here is a sort of current map of the major, not every, but the major flight patterns that happen every day around the world. If you looked 30 years ago you would actually be able to see some green under that map but so diseases will spread even quicker. What happened with monkey pox is exactly, pardon me, what happened with polio. We had to think about fractional doses and therefore intradermal delivery so that will also occur and the investment on delivery has not and is not yet keeping pace. Like I mentioned this morning in the opening, we work with a country in West Africa that received 35 million vaccine doses and had to throw away 20 million because of logistics and deployment and delivery problems. These types of issues will keep occurring.

The idea of creating delivery partnerships. Partnering that upstream developers and research organizations can partner with delivery partners in the field to get vaccines out is going to be something we’re going to have to do more and more. A couple of potential solutions microarray patches vaccine coated and dissolving. There’s manufacturing and use challenges that are there this is something that we need to consider for measles. There’s been long-standing options for deployment on this these haven’t reached the manufacturing level but I think it’s something that can look forward to.

As as we move our own work on Blow-Fill-Seal prefilled injectors, they allow for very simple container and a health worker at the point of care to be able to deliver vaccine easily. Putting this idea of patient needs and the actual delivery of vaccinations at the center of the clinical development of vaccines. I’m sure I’m not the first person to say that and obviously we’re a delivery group so that’s what we think about but it’s like both for me working at the delivery side where I was banging the end of the hose against the wall trying to get water to come out without going back upstream and trying to examine where the source of the water is.

The idea also that we turn the water on our clinical development pathways without seeing where the Kinks are in the hose and who’s holding the hose at the end of the day it’s something that we can think a lot more about and hope that sort of next year if our chair invites us back and if we can have an entire panel looking at alternative delivery and some of these other solutions. Thanks very much.

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