- Ben Morris
- Technology of Business Editor
“Infectious diseases evolve much faster than us and much faster than our defenses.”
“I think it is deeply naive to think that we have them under control,” says Richard Hatchett, executive director of the Coalition for Epidemic Preparedness Innovations (CEPI).
His organization was created after the 2014 Ebola outbreak, when a vaccine was developed, but too late to have an impact on the outbreak.
With more than $ 750 million (£ 571 million) from governments and organizations like the Bill & Melinda Gates Foundation, it is funding promising new vaccine technologies.
In particular, CEPI wants vaccines that can be produced quickly.
“In most of the circumstances where we have an epidemic, speed becomes really, really important,” Hatchett said.
Traditionally, vaccines are made by taking the original virus or bacteria and somehow deactivating it.
The idea is to degrade the microbe so that it is no longer a threat to health, but can nevertheless trigger an immune system response.
The body can then use this immune response if it comes into contact with the true infection.
This type of approach has had tremendous success, saving millions of lives.
The problem is that developing and manufacturing vaccines this way is slow and expensive.
Frédéric Garzoni is one of the many scientists who hope to change all this.
He spent years in France working on proteins, examining and fine-tuning the building blocks of bodies.
But in 2016, he stumbled upon something that he thinks was very special.
A protein structure that self-assembles into a molecule, which can be easily manipulated and produced in large quantities, and can perhaps be used to vaccinate against a multitude of diseases.
“I thought it was the best protein I’ve seen in 15 years. I’m quitting my job and I’m going to focus on that,” he said.
Garzoni and others manipulate all kinds of microbes, often at the DNA level, to work particles that stimulate the immune system.
His research was aided by powerful tools, including cryogenic electron microscopy (cryo-EM), a procedure that lowers samples to extremely low temperatures and then uses electrons.
The resulting images render details almost atomic, allowing scientists to identify useful properties, which would have been unknown before the advent of cryo-EM.
At the University of Bristol, these images have been combined with powerful cloud-computing services provided by US technology giant Oracle, which make it possible to create detailed images faster and more cheaply than ever before.
With this kind of detail, researchers can identify all kinds of useful properties.
There are dozens of different research groups that are developing new technologies to create vaccines in different ways.
Jon Cuccui is Associate Professor of Microbiology at the London School of Hygiene and Tropical Medicine.
His research has focused on vaccines to fight bacterial infections.
The approach has been to use a safe strain of the bacterium escherichia ecoli as a molecular factory to produce a sugar-protein complex, which can recognize many dangerous infections.
“You end up with an endless amount of vaccine, which is scalable … and therefore much cheaper to produce,” he said.
Several vaccines produced using this technology are already in clinical trials.
Dr. Cuccui says the ability to quickly determine an organism’s genetic blueprint and then change that blueprint has made a big difference in his research.
“We can go and target an organism and develop a prototype vaccine at a much faster rate than 10 to 20 years ago.”
The long road to vaccine approval
Once scientists have developed a promising vaccine, they conduct preclinical trials in mice and larger animals.
This step alone can take years of research. But if the treatment shows any promise, it will be tested in humans.
• Phase I clinical trials. Small-scale trials (up to 100 people) to assess whether the vaccine is safe for humans and what should be the best dose.
• Phase II clinical trials are larger (several hundred) and are primarily aimed at evaluating the efficacy of the vaccine against man-made infections and clinical diseases. The safety of vaccines, side effects and the immune response are also studied.
• Phase III clinical trials are large-scale studies (up to thousands of subjects at multiple sites) to see how the vaccine works under naturally occurring disease conditions. If the vaccine maintains its safety and efficacy for a defined period of time, the manufacturer may apply to regulatory authorities for a license to market the product for human use.
• Phase IV occurs after the vaccine has been licensed and put into use. Also called post-marketing surveillance, this step aims to detect rare side effects as well as to assess long-term efficacy.
Being able to develop and manufacture vaccines at a lower cost is the goal of Mr. Hatchett’s organization, CEPI.
“We don’t just want to develop high-priced vaccines that can only be bought by the 1% in the developed world … the epidemic diseases we are focusing on are much more likely to appear in low-income countries. and intermediate, “he says.
The giant pharmaceutical companies are among the most important operators in the vaccine industry.
GSK is one of the largest players in the field, making vaccines that protect against 21 diseases.
“For me, it’s a new golden age of vaccines,” explains William “Rip” Ballou, head of US vaccine research at pharmaceutical giant GSK.
He’s particularly excited about a technology, called self-amplifying mRNA (SAM), which starts with part of a virus’s genetic code, turning it into messenger RNA (molecules that carry instructions for the body on how to build protein).
Once injected into the body, the molecule can use the body’s own systems to trigger an immune response to the original virus.
It potentially allows GSK to find candidate vaccines faster, which could be vital in responding to an epidemic.
It could also revolutionize vaccine manufacturing.
At the moment, each vaccine has its own dedicated production line, but SAM could see the same equipment used to make different vaccines – which would be much cheaper and faster.
“It really is breathtaking technology,” says Ballou.
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