[ad_1]
COVID-19 | Cutting-edge technology that transforms the body into a vaccine factory to eliminate viruses is poised to revolutionize the fight against Covid-19, and future pandemics and even cancer could be next, scientists say.
The initial success of so-called messenger ribonucleic acid (mRNA) vaccines in late-stage trials by Moderna, as well as by Pfizer and its German partner BioNTech is the first proof that the concept works.
Both experimental vaccines had efficacy rates greater than 90 percent according to the interim findings, which was much higher than expected and well above the 50 percent threshold that US regulators insist on for vaccines.
Now scientists say the technology, a slow-motion revolution in the works since the discovery of mRNA nearly 60 years ago, could accelerate the development of new vaccines.
The traditional method of creating vaccines – introducing a weakened or killed virus, or part of one, to boost the body’s immune system – takes more than a decade on average, according to a 2013 study. A pandemic influenza vaccine took more than eight years, while a hepatitis B vaccine took almost 18 years to prepare.
Moderna’s vaccine went from genetic sequencing to the first human injection in 63 days.
With BioNTech and Pfizer’s Covid-19 candidate on a similar trajectory, both could win regulatory approval this year, just 12 months since the coronavirus emerged.
Other companies seeking the technology, such as Germany’s CureVac, also have an mRNA vaccine candidate, though a late-stage trial has yet to begin and hopes to receive the green light after July 2021.
“We will look back at the progress made in 2020 and say, ‘That was a time when science really took a leap forward,'” said Jeremy Farrar, director of the University of Oxford’s Clinical Research Unit, backed by Wellcome Trust.
The last laugh
Discovered in 1961, mRNA carries messages from the body’s DNA to cells, instructing them to produce proteins necessary for critical functions, such as coordinating biological processes such as digestion or fighting disease.
The experimental vaccines from Moderna, as well as from Pfizer and BioNTech, use laboratory-made mRNA to instruct cells to make the coronavirus spike proteins, which stimulate the immune system to act without replicating like the real virus.
In 1990, scientists got mice to make proteins by injecting mRNA, an early sign of the technology’s potential.
But early proponents, such as Katalin Kariko, a Hungarian-born scientist and senior vice president at BioNTech, were hampered by obstacles such as mRNA instability in the body and its propensity to cause inflammatory responses.
A breakthrough came around 2005 when Kariko, along with her colleagues at the University of Pennsylvania, figured out how to deliver mRNA without the immune system kicking in.
Still, it took another 15 years, and a pandemic that brought the global economy to its knees, to reach the pinnacle of success. Kariko said her years of dogged persecution once made her the butt of jokes from some college colleagues.
“The last time they laughed at me and made fun of me was when they found out that I was joining BioNTech seven years ago and they realized that this company (didn’t) even have a website,” he said. Reuters. “But now, they learn from BioNTech and that we can do good things.”
Kariko said her life’s work could pay dividends, not only against Covid-19, but also against other diseases.
“It might be easier to navigate to the next anti-viral product, a vaccine for influenza and other infectious diseases,” said Kariko, whose daughter is a United States Olympic gold medalist rower.
Cancer later?
Moderna and BioNTech, for example, are also applying mRNA technology to experimental cancer drugs.
BioNTech is testing an anti-melanoma mRNA with Swiss pharmaceutical giant Roche in a phase II trial. Among Moderna’s most advanced projects, in addition to its Covid-19 vaccine, are mRNA compounds to treat ovarian cancer or myocardial ischemia, which are also in the second phase of testing.
However, none of the potential cancer mRNA therapies have reached critical large-scale Phase III trials, and Kariko acknowledges that cancer presents a greater challenge.
While a virus is a strange intruder, cancer cells, however malignant, come from inside the body, making them more difficult to find and expose so they can be attacked.
“Sometimes cancer is simply caused by the duplication of genes and chromosomes and then everything seems normal and the cell is dividing more than it should,” he said.
For infectious disease vaccines, the traditional approach of the pharmaceutical industry has been to prepare them in large bioreactors, an expensive and time-consuming process in facilities that can cost up to $ 700 million to build.
In contrast, Zoltan Kis, a researcher at Imperial College London who models vaccine manufacturing, estimates that a five-liter bioreactor within a $ 20 million facility could produce 1 billion doses of some types of mRNA vaccines. year.
Drug maker Lonza, enlisted to make ingredients for 400 million doses of Moderna’s vaccine annually at sites in the US and Switzerland, will start production this year, and the manufacturing lines will cost between $ 60 and $ 70 million. each.
“We are producing mRNA at smaller scales and in smaller facilities compared to traditional larger-scale equipment and facilities,” said Andre Goerke, Lonza’s global leader for the Moderna project. Reuters. “Accelerating manufacturing is faster and cheaper.”
‘Lightning fast response’
Raymond Schiffelers of the Utrecht University Medical Center in the Netherlands, which runs a European Union program for mRNA therapies, said the main advantage of the technology was that vaccine developers could mount an “ultra-fast response.”
“In a few weeks, trials can begin, a huge advantage over conventional vaccines,” he said.
As soon as the genomic sequence of a pathogen is known, synthetic mRNAs can be designed to encode key parts of the virus, such as the potentially lethal spike protein of the coronavirus.
Risks and challenges remain for mRNA.
Some candidates must be stored in extremely cold temperatures, making delivery difficult in countries with limited infrastructure. They can also be fragile to transport, Schiffelers said.
BioNTech’s vaccine, for example, must be transported at minus 70 degrees Celsius, although Moderna said Monday that it can ship its candidate in normal refrigerators.
Francis Collins, director of the US National Institutes of Health (NIH), which funded the development of Moderna’s vaccine, also said mRNA vaccines may not be a silver bullet for the flu, as it mutates so rapidly that it is unlikely to be 90 percent effective.
But for Covid-19, Collins said mRNA is likely to be a revolution.
“It is clearly several months faster than any of the other methods,” Collins said. “In a time of crisis, several months really matter.”
– Reuters
