Chemicals & raw materials
doses offers 90% protection against shingles that stays above 85% for at least four years. As well as making them more effective, delivery technology can help to make vaccines safer, and this is the direction that the field is moving in, says Roy. “I think there will be a lot more adjuvants and combination adjuvants coming in with a better safety profile and that are packaged [within delivery technology].” Roy has received funding from the NIH to screen and evaluate potential adjuvants for Covid vaccines, and considering how they could be delivered has been a key part of this work. For O’Hagan, formulation delivery is a crucial area of focus as the field advances. “It creates the adjuvant system that makes everything else happen,” he says. “In the bigger picture perspective…it’s every bit as important as all the other sophisticated immunological cells. It’s what triggers, it’s what controls.”
GSK’s Shingrix vaccine offers 90% protection against shingles after two doses.
highly effective against certain types of HPV. Could we soon see vaccines with similar efficacy in other therapy areas? Researchers are working on it. Many adjuvants are currently in clinical development for diseases such as tuberculosis, malaria, and the flu.
Delivery technology
Identifying an adjuvant is only part of the battle – how it behaves once it’s delivered into the body can determine how well the vaccine works, and what sort of side effects it creates. This is where delivery technology comes in. Adjuvants can be incorporated into lipid nanoparticles or other nano formulations or emulsions, and the formulation in which they are delivered can affect whether the right cells and tissue are being targeted without causing any systemic toxicity, says Derek O’Hagan, senior vaccines R&D advisor and GSK fellow at GSK. “It’s a delivery challenge, to ensure that you’re getting the right activation signal in a controlled fashion, so you’re not going to trigger adverse effects because you’ve got too much activation of too many cells.”
“In the bigger picture perspective…it’s every bit as important as all the other sophisticated immunological cells. It’s what triggers, it’s what controls.”
Derek O’Hagan, GSK
GSK uses the concept of adjuvant systems (AS), a term they’ve coined, to create adjuvants whose formulation considers how they will be delivered into the body. AS04 is one such adjuvant, alongside others AS01 and AS03. One success story is GSK’s Shingrix vaccine, which uses AS01 with a single glycoprotein, and from two
46 Focus on the future
The potential of adjuvants is immense. Not only could we have vaccines that are more effective, last longer, and have fewer side effects, but researchers have their sights set on huge global disease areas. “HIV, malaria, TB, and a universal flu vaccine are the big four we were trying to address before the pandemic,” says Dr Milicic of her work at the Jenner Institute. Now, Covid-19 is in the mix, too. For Dr Levy, adjuvants hold huge potential in precision medicine, as different populations can react differently to the same formulation. “We’ve developed the techniques to allow us to accelerate and de-risk adjuvant development and to tailor the adjuvant, so it’s more suitable for a particular vulnerable population that you’re trying to protect,” he says. Plus, thanks to the pandemic, getting a vaccine from the lab to the clinic might become easier, too. "When it comes to vaccines, the coronavirus pandemic has broadened our mindsets. Novel vaccine approaches and formulations, as long as they show good safety and efficacy, may become easier to gain regulatory approvals for the future,” says Dr Milicic. Ultimately, the potential of adjuvants lies in how well we can understand the science behind their mechanisms – and how we can use this knowledge to influence the immune system, says O’Hagan.
“Can we have what we call an adjuvant, which is a molecule that modulates the immune system, to do something completely different? What about where the immune system has not quite done what we want it to do, say by clearing cancer? Can we give the immune system a boost to help it do that? Maybe.” The same could be true for a variety of therapy areas, including autoimmune diseases, chronic infectious diseases, or a situation where the immune system has gone awry, he adds. “Can we get in there and modulate it? I think this is the space that’s in front of us.” ●
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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