Filmed June 2013 at TED Global 2013 Edinburgh, Scotland
Transcript
0:11 It 's a pleasure to be here in Edinburgh, Scotland, the birthplace of the needle and syringe. Less than a mile from here in this direction, in 1853 a Scotsman filed his very first patent on the needle and syringe. His name was Alexander Wood, and it was at the Royal College of Physicians. This is the patent. What blows my mind when I look at it even today is that it looks almost identical to the needle in use today. Yet, it 's 160 years old.
0:43 So we turn to the field of vaccines. Most vaccines are delivered with the needle and syringe, this 160-year-old technology. And credit where it …show more content…
's due -- on many levels, vaccines are a successful technology. After clean water and sanitation, vaccines are the one technology that has increased our life span the most. That 's a pretty hard act to beat.
1:11 But just like any other technology, vaccines have their shortcomings, and the needle and syringe is a key part within that narrative -- this old technology.
So let 's start with the obvious: Many of us don 't like the needle and syringe. I share that view. However, 20 percent of the population have a thing called needle phobia. That 's more than disliking the needle; that is actively avoiding being vaccinated because of needle phobia. And that 's problematic in terms of the rollout of …show more content…
vaccines.
1:45 Now, related to this is another key issue, which is needle stick injuries. And the WHO has figures that suggest about 1.3 million deaths per year take place due to cross-contamination with needle stick injuries. These are early deaths that take place.
2:02 Now, these are two things that you probably may have heard of, but there are two other shortcomings of the needle and syringe you may not have heard about. One is it could be holding back the next generation of vaccines in terms of their immune responses. And the second is that it could be responsible for the problem of the cold chain that I 'll tell you about as well.
2:23 I 'm going to tell you about some work that my team and I are doing in Australia at the University of Queensland on a technology designed to tackle those four problems. And that technology is called the Nanopatch. Now, this is a specimen of the Nanopatch. To the naked eye it just looks like a square smaller than a postage stamp, but under a microscope what you see are thousands of tiny projections that are invisible to the human eye. And there 's about 4,000 projections on this particular square compared to the needle. And I 've designed those projections to serve a key role, which is to work with the skin 's immune system. So that 's a very important function tied in with the Nanopatch.
3:13 Now we make the Nanopatch with a technique called deep reactive ion etching. And this particular technique is one that 's been borrowed from the semiconductor industry, and therefore is low cost and can be rolled out in large numbers.
3:28 Now we dry-coat vaccines to the projections of the Nanopatch and apply it to the skin. Now, the simplest form of application is using our finger, but our finger has some limitations, so we 've devised an applicator. And it 's a very simple device -- you could call it a sophisticated finger. It 's a spring-operated device. What we do is when we apply the Nanopatch to the skin as so -- (Click) -- immediately a few things happen. So firstly, the projections on the Nanopatch breach through the tough outer layer and the vaccine is very quickly released -- within less than a minute, in fact. Then we can take the Nanopatch off and discard it. And indeed we can make a reuse of the applicator itself.
4:22 So that gives you an idea of the Nanopatch, and immediately you can see some key advantages. We 've talked about it being needle-free -- these are projections that you can 't even see -- and, of course, we get around the needle phobia issue as well.
4:36 Now, if we take a step back and think about these other two really important advantages: One is improved immune responses through delivery, and the second is getting rid of the cold chain.
4:49 So let 's start with the first one, this immunogenicity idea. It takes a little while to get our heads around, but I 'll try to explain it in simple terms. So I 'll take a step back and explain to you how vaccines work in a simple way. So vaccines work by introducing into our body a thing called an antigen which is a safe form of a germ. Now that safe germ, that antigen, tricks our body into mounting an immune response, learning and remembering how to deal with intruders. When the real intruder comes along the body quickly mounts an immune response to deal with that vaccine and neutralizes the infection. So it does that well.
5:29 Now, the way it 's done today with the needle and syringe, most vaccines are delivered that way -- with this old technology and the needle. But it could be argued that the needle is holding back our immune responses; it 's missing our immune sweet spot in the skin. To describe this idea, we need to take a journey through the skin, starting with one of those projections and applying the Nanopatch to the skin. And we see this kind of data. Now, this is real data -- that thing that we can see there is one projection from the Nanopatch that 's been applied to the skin and those colours are different layers. Now, to give you an idea of scale, if the needle was shown here, it would be too big. It would be 10 times bigger than the size of that screen, going 10 times deeper as well. It 's off the grid entirely. You can see immediately that we have those projections in the skin. That red layer is a tough outer layer of dead skin, but the brown layer and the magenta layer are jammed full of immune cells. As one example, in the brown layer there 's a certain type of cell called a Langerhans cell -- every square millimetre of our body is jammed full of those Langerhans cells, those immune cells, and there 's others shown as well that we haven 't stained in this image. But you can immediately see that the Nanopatch achieves that penetration indeed. We target thousands upon thousands of these particular cells just residing within a hair 's width of the surface of the skin.
6:54 Now, as the guy that 's invented this thing and designed it to do that, I found that exciting. But so what? So what if you 've targeted cells? In the world of vaccines, what does that mean? The world of vaccines is getting better. It 's getting more systematic. However, you still don 't really know if a vaccine is going to work until you roll your sleeves up and vaccinate and wait. It 's a gambler 's game even today.
7:20 So, we had to do that gamble. We obtained an influenza vaccine, we applied it to our Nanopatches and we applied the Nanopatches to the skin, and we waited -- and this is in the live animal. We waited a month, and this is what we found out. This is a data slide showing the immune responses that we 've generated with a Nanopatch compared to the needle and syringe into muscle. So on the horizontal axis we have the dose shown in nanograms. On the vertical axis we have the immune response generated, and that dashed line indicates the protection threshold. If we 're above that line it 's considered protective; if we 're below that line it 's not. So the red line is mostly below that curve and indeed there 's only one point that is achieved with the needle that 's protective, and that 's with a high dose of 6,000 nanograms. But notice immediately the distinctly different curve that we achieve with the blue line. That 's what 's achieved with the Nanopatch; the delivered dose of the Nanopatch is a completely different immunogenicity curve. That 's a real fresh opportunity. Suddenly we have a brand new lever in the world of vaccines. We can push it one way, where we can take a vaccine that works but is too expensive and can get protection with a hundredth of the dose compared to the needle. That can take a vaccine that 's suddenly 10 dollars down to 10 cents, and that 's particularly important within the developing world.
8:46 But there 's another angle to this as well -- you can take vaccines that currently don 't work and get them over that line and get them protective. And certainly in the world of vaccines that can be important. Let 's consider the big three: HIV, malaria, tuberculosis. They 're responsible for about 7 million deaths per year, and there is no adequate vaccination method for any of those. So potentially, with this new lever that we have with the Nanopatch, we can help make that happen. We can push that lever to help get those candidate vaccines over the line. Now, of course, we 've worked within my lab with many other vaccines that have attained similar responses and similar curves to this, what we 've achieved with influenza.
9:26 I 'd like to now switch to talk about another key shortcoming of today 's vaccines, and that is the need to maintain the cold chain. As the name suggests -- the cold chain -- it 's the requirements of keeping a vaccine right from production all the way through to when the vaccine is applied, to keep it refrigerated. Now, that presents some logistical challenges but we have ways to do it. This is a slightly extreme case in point but it helps illustrate the logistical challenges, in particular in resource-poor settings, of what 's required to get vaccines refrigerated and maintain the cold chain. If the vaccine is too warm the vaccine breaks down, but interestingly it can be too cold and the vaccine can break down as well.
10:16 Now, the stakes are very high. The WHO estimates that within Africa, up to half the vaccines used there are considered to not be working properly because at some point the cold chain has fallen over. So it 's a big problem, and it 's tied in with the needle and syringe because it 's a liquid form vaccine, and when it 's liquid it needs the refrigeration.
10:37 A key attribute of our Nanopatch is that the vaccine is dry, and when it 's dry it doesn 't need refrigeration. Within my lab we 've shown that we can keep the vaccine stored at 23 degrees Celsius for more than a year without any loss in activity at all. That 's an important improvement. (Applause) We 're delighted about it as well. And the thing about it is that we have well and truly proven the Nanopatch within the laboratory setting. And as a scientist, I love that and I love science. However, as an engineer, as a biomedical engineer and also as a human being, I 'm not going to be satisfied until we 've rolled this thing out, taken it out of the lab and got it to people in large numbers and particularly the people that need it the most.
11:32 So we 've commenced this particular journey, and we 've commenced this journey in an unusual way. We 've started with Papua New Guinea.
11:40 Now, Papua New Guinea is an example of a developing world country. It 's about the same size as France, but it suffers from many of the key barriers existing within the world of today 's vaccines. There 's the logistics: Within this country there are only 800 refrigerators to keep vaccines chilled. Many of them are old, like this one in Port Moresby, many of them are breaking down and many are not in the Highlands where they are required. That 's a challenge. But also, Papua New Guinea has the world 's highest incidence of HPV, human papillomavirus, the cervical cancer [risk factor]. Yet, that vaccine is not available in large numbers because it 's too expensive. So for those two reasons, with the attributes of the Nanopatch, we 've got into the field and worked with the Nanopatch, and taken it to Papua New Guinea and we 'll be following that up shortly.
12:37 Now, doing this kind of work is not easy. It 's challenging, but there 's nothing else in the world I 'd rather be doing. And as we look ahead I 'd like to share with you a thought: It 's the thought of a future where the 17 million deaths per year that we currently have due to infectious disease is a historical footnote. And it 's a historical footnote that has been achieved by improved, radically improved vaccines. Now standing here today in front of you at the birthplace of the needle and syringe, a device that 's 160 years old, I 'm presenting to you an alternative approach that could really help make that happen -- and it 's the Nanopatch with its attributes of being needle-free, pain-free, the ability for removing the cold chain and improving the immunogenicity. Thank you. (Applause)
SUMMARY
Needles and syringe were first developed in Edinburgh, Scotland in 1853. Today, vaccines are delivered via the needle and syringe – a technology that is 160 years old. Biomedical engineer Mark Kendall offers an alternative method to apply vaccines, one that combats four major shortcomings of the modern needle and syringe – the Nanopatch.
The Nanopatch is a 1cm2 silicon patch that is covered in thousands of projections.
The tiny projections are covered in a dry vaccine powder to deliver a small dose of vaccine. These projections penetrate past the dead skin cells and into the immune cells that lay directly beneath the skin cells. The Nanopatch is easily applied using an applicator, immunising a person in about a minute and is then safely disposed of once removed. It is made for less than $1 as it uses only a fraction of a vaccine dose delivered by traditional syringe methods. The process does not draw blood, reducing the risk of infection and at the same time eliminates the risk of needle stick injuries. As the Nanopatch does not contain liquid vaccine but dry vaccine, it is not required to be refrigerated and therefore is transported with ease.
How vaccines work:
Vaccines introduce the body to an antigen – a safe form of a germ. The antigen tricks the body into mounting an immune response, learning and remembering how to deal with intruders. When the body is subjected to the real intruder, the body quickly mounts an immune response to deal with that vaccine, and neutralises the infection.
Short comings of using traditional needle and syringe to deliver vaccines:
1. Pain – 20% of the population have needle-phobia. People deliberately avoid getting injections and vaccines due to their
fears.
2. Cross contamination of syringes – cross contamination is the cause of 1.3 million deaths annually.
3. Holding back next generation of vaccines – the dosage to be considered immune or protected (i.e. vaccinated) are high in comparison to the amount of vaccine needed for the Nanopatch.
4. Maintaining the cold chain – Vaccines applied via needles and syringes are in liquid form and need to be refrigerated from production to application, staying at a constant temperature. If the vaccine is either too warm or too cold, it will break down and will not have the same effect on the immune system after being applied.
The alternative method of delivering vaccines is the NANOPATCH.
- needle free
- pain free
- the ability to eradicate the cold chain
- improving immunity
IMPACT ON SOCIETY
Along with clean water and sanitation, vaccines are the one technology that has increased our life span as humans. The Nanopatch is an invention that acknowledges the importance of vaccines and the benefits that society would receive by using this alternative method.
PAIN - The Nanopatch is a substitute for those who are afraid of needles and those with low pain thresholds. By introducing a pain free vaccine, people are able to receive important vaccinations instead of avoiding them, therefore opening up vaccinations to more people.
COST - The nanopatch is produced at 1/100th of the price in comparison to needle and syringe vaccines. Reducing the costs of vaccines allows poorer regions and countries access to these vaccinations, overall aiding their health. To become ‘immune’ or to be considered ‘protected’ the dosage tends to be relatively high when using a syringe that penetrates muscle. The nanopatch has shown that it requires a fraction of the dosage, to be above the protective threshold, which instantly reduces costs by decreasing the size of the vaccine required. This cost efficiency is particularly important within developing countries as it enables opportunities for affordable vaccinations, which in turn prevents against viruses and illness, boosting the health of that country.
COLD CHAIN - As the Nanopatch is silicon square, dry coated in vaccine, it does not require refrigeration. The Nanopatch has been stored at 23 degrees for more than a year without any loss of activity in effectiveness, proving that refrigeration is no longer required. Due to the reduced reliance on the cold chain, the Nanopatch can be distributed and transported without the inconvenience of controlled refrigeration. This increases the accessibility of vaccines to remote communities eliminating refrigeration costs. It opens up the opportunity for vaccines to be available to poorer countries who do not have refrigerators or communities who live without electricity. Papua New Guinea for example, has only 800 refrigerators to keep vaccines chilled, the majority of which are in the city and not in remote areas where vaccines are required. The number of broken down vaccines will reduce as the temperature control is no longer a high priority with the dry coated Nanopatch vaccine.
CROSS CONTAMINATION - The Nanopatch would reduce cross contamination as the Nanopatch is a single use patch only. The small 1cm2 silicon patch is peeled off one minute after application, and is then discarded into a bin. There is no need for a sharps bin or sterilisation as the patch is disposable and is not prepared for use again. The applicator can be used multiple times without bringing harm or aiding illness. The Nanopatch uses tiny powder-coated spikes to deliver a vaccine, so small that the process does not draw blood. This eliminates the risk of needle injuries and reduces the risk of infections.
NEW RESEARCH - The Nanopatch has introduced a whole new idea of vaccines by looking at a new method of applying vaccines in a cost effective, pain free process. An experiment using influenza vaccines on animals, has shown that the application of the Nanopatch vaccination triggers more immune system responses in comparison to the needle and syringe application. This study has opened up further exploration and research for scientists, in terms of the reasoning behind the high immune responses to this alternative method of vaccination with lower vaccine dosages.
Economic - Economically the Nanopatch is a brilliant invention. In comparison to syringes the Nanopatch is cheap and cost effective, being produced at a fraction of the cost. It is easily made by deep reactive ion etching at a low cost and can be made in large quantities – mass production. The Nanopatch has proven that it requires a significantly smaller dosage of vaccine to be effective in preventing viruses. Decreasing the amount of vaccine needed per vaccination means saving money by not spending as much for one vaccine. For example one vaccine applied via the needle and syringe may cost $10 but applied via a Nanopatch it may cost $0.10 as there is less vaccine needed. The decrease in costs allows poorer regions and countries access to these vaccinations, overall aiding their health. This cost efficiency is particularly important within developing countries as it offers affordable vaccinations to these areas of lower socioeconomic status and poorer regions.
Socially - The Nanopatch does not require the same special training or qualifications needed to deliver vaccines to patients via the needle and syringe. This means that medical practitioners in Australia can easily educate health clinic staff in developing countries on how to apply the Nanopatch. These local medical staff are then able to continue using the Nanopatch method and transport them to remote communities in need of vaccinations to prevent viruses. By educating locals, the Nanopatch method of delivering vaccines is surely to improve health and wellbeing in the areas that are poor and cannot afford traditional vaccines, and areas that have little access to health care. Are there concerns or problems that this might raise?
The Nanopatch raises some concerns even in its innovative brilliance.
• The Nanopatch does require some temperature monitoring. Rather than keeping it cool is cannot be exposed to extreme temperatures. This would mean storing the Nanopatch at room temperature and preventing them from being exposed to extreme hot and extreme cold temperatures that exceed the optimal temperature of 23 degrees celsius.
• Environmentally it is reducing the number of needles and syringes used yet increases the amount of silicon used. As the patches are so small the effect on the environment would not be severe. The most environmentally sustainable condition needs to be taken into consideration when disposing the Nanopatches. Do they go into ordinary waste? Is there a need for special bins or removal?
• People may question the dosage size of vaccine required to immunise a person. There is less vaccine required yet the Nanopatch manages to be just as effective in preventing viruses, if not it is an improvement in stimulating immune responses.
Bibliography
Kendall, M June 2013, ‘A needle-free vaccine patch that 's safer and way cheaper’, TED Viewed 10th February 2014 https://www.ted.com/talks/mark_kendall_demo_a_needle_free_vaccine_patch_that_s_safer_and_way_cheaper
University of Queensland 2014, ‘Research: Delivery of Drugs and Genes Group’ viewed 30th March 2014, http://www.uq.edu.au/d2g2/research