Text of my ‘When Worlds Collide’ column published in Ceylon Today Sunday newspaper on 2 December 2012
Vaccines have been called ‘travel insurance for life’ – their life-saving and life-enhancing capability is second only to that of safe drinking water.
We have had modern vaccines only for a couple of centuries and now take their protection completely for granted. But not everyone is covered – some vaccines are still beyond the reach of millions in the developing world because of cost, or the logistics of getting it across.
Most vaccines are fragile bio products that need to be stored at a temperature of between 2 and 8 degrees centigrade, from the time they are made to the point of administration. Any disruption in this ‘cold chain’ can reduce efficacy or make them invalid.
Even as new vaccines are being introduced against various diseases, delivering them safely to those who need it most remains a big challenge.
Professor Mark Kendall, an Australian bio-engineer, has a solution. He is developing a “Nanopatch” to replace needles in vaccination. By making vaccination painless, safer, cheaper and altogether more effective, the new technology can dramatically lower the cost of immunization. It can eventually save millions of lives in the developing world.
This week, he received a Rolex Award for Enterprise in support of his ongoing research work. The prestigious award will provide both recognition and global publicity.
“Frustration has been a key motivation for me,” he said accepting the award at the global ceremony held in New Delhi, India. “I’m frustrated by how vaccines are currently developed in the developed world and slowly trickle down to the developing world.”
A Small Wonder
For much of the two centuries since the English physician Edward Jenner introduced modern immunisation, vaccines have been injected with a hypodermic needle. The few exceptions are either oral (polio) or intra-nasal (influenza).
The ‘Nanopatch’ is a fundamentally different method of delivering dry vaccines. It applies a tiny dose just under the skin with precision and with more than 100 times the efficacy of needle delivery.
Traditional skin patches — like the nicotine patch – deliver chemicals through diffusion, i.e. molecules finding their way through small gaps within the skin. But vaccine molecules are too large for that process.
The Nanopatch, itself around 1 cm by 1 cm in size, contains thousands of tiny projections that are too small to be seen by the human eye. Coated on each projection is the vaccine in dry-coated form.
When the patch is pushed on to the skin by an applicator device, the projections push through the outer layer of the skin. As the tiny projections enter the skin, the vaccine becomes wet, and it goes into the skin’s immune cells. The process takes about one minute, and because it doesn’t go deep into the skin where nerve endings are located, the process is painless.
“The knowledge of the skin’s immunological benefits has been found by modern medicine only in the past decade or two. But Brahmins in India have been doing things on the skin some 2,000 years, so it looks like we’re coming full circle,” Kendall said in an interview.
Kendall, attached to the Australian Institute for Bioengineering and Nanotechnology at the University of Queensland in Brisbane, is using the latest computer-chip technology to make Nanopatches.
The applicator, a small plastic device that looks far less sinister than a syringe, doesn’t have any sharp end, so it’s not possible to accidentally inject anything. That means all needle stick injuries are avoided.
The World Health Organisation (WHO) estimates that out of a billion needles uses in Africa each year, approximately a third is unsafe — causing injury or cross-contamination.
Cheap and versatile
Another issue is that some people are terrified of needles. One study found that needle phobia is responsible for around one in 8 persons choosing not to be vaccinated.
The biggest benefits of Nanopatch are in vaccine cost and storage.
This dry vaccine doesn’t require any refrigeration. It can be stored at 23 degrees centigrade for 15 months – as long as low humidity is ensured.
“We don’t yet know how high and low the temperatures can go with each vaccine embedded on a Nanopatch – we’re doing field experiments with human popilloma virus (HPV) vaccine,” Kendall says.
The economics are compelling. It costs around USD 50 to make the current generation of HPV on the market (without factoring any R&D costs). In a place like Australia, the costs of storage, transport and administration, adds up to a total of around USD 200 per vaccine.
“The Nanopatch needs only a hundredth of the current HPV dose, and instead of three shots, only two. So when we do the math, we find it costs only around US 50 cents per person to vaccinate,” Kendall says.
When added to the cost of a Nanopatch (made of silicon or polycarbonate) and its applicator, both of which can be mass produced for cheap, the total is still “significantly lower than a dollar”.
The researchers have set up a company called VAXXAS in Brisbane to promote Nanopatch use in developed countries. The Rolex Award, which carries Swiss francs 100,000, will allow the team to simultaneously pursue it in the developing world. More funding is also being sought from other philanthropic foundations.
The first usability trials have recently been carried out at the Port Moresby General Hospital in Papua New Guinea (PNG), where the patch (without any vaccine) and applicator were tested with doctors and nurses.
Why PNG? “It’s our next door neighbour from Queensland. We want to test this in developing world conditions. Instead of going all the way to Africa, we are doing it in PNG.”
Also, PNG has the highest incidence of HPV in the world and there is no HPV vaccine available there. HPV leads to cervical cancer in women.
“We made these devices and got them in the hand of practitioners to simulate field conditions. We’ve got our patches stored in sealed packages – it’s very important that they remain dry, even though they don’t need refrigeration,” says Kendall.
He adds: “We’ve demonstrated with animal testing that the Nanopatch works with seven classes of vaccines and improves the efficacy too.”
The next stage is clinical trails with humans, which is a long and tightly regulated process – even if it uses already approved and used vaccines, where only the delivery method is new.
“I like the Nanopatch to be on the market in 10 years. That’s the rigorous process of safety reviews and approvals, which takes time,” Kendall says. “I like to think that eventually millions of lives can be saved. It will start with one or two vaccines and eventually cover more and more infections.”
Lankan-born vaccinologist Dr Germain Fernando is part of the University of Queensland team, and leads action on the ‘flu vaccine project. The Nanopatches’ many attributes are advantages to vaccination programmes not only in Sri Lanka but in all developing countries, he said in an email interview.
While deep immersed in the nitty gritty of biotech innovation, Kendall sees the bigger picture. Working in PNG has exposed him to the harsh realities of the developing world.
He says: “HIV, malaria and tuberculosis are the big three (infections) that, between them, account for some 7 million deaths per year. Currently there are no vaccines for these, but what’s even more shocking is that there are other diseases where vaccines have been developed but are not readily available in the developing world.”
Even in places where vaccination is happening, people still die due to failures in the cold chain which render the vaccines inactive, he says. “The Nanopatch overcomes this because it doesn’t need refrigeration.”
The bio-engineer sums up: “There are many big problems out there waiting to be tackled. They don’t come neatly packaged. We just need to work across cultures and professional disciplines to solve them.”