Recent outbreaks such as Ebola and Zika alarmed vaccine experts, who worry that the scientific community isn’t prepared for emerging diseases. That concern has sparked new funding and collaboration—and along the way, experts say, vaccine science is advancing to speed up the fight against new pathogens.
Platform manufacturing, for example, can radically shorten the vaccine development timeline, National Institute for Allergy and Infectious Diseases scientists wrote in an article published in the Journal of the American Medical Association.
Newer approaches include DNA vaccines, mRNA vaccines, viral vectors, nanoparticles and virus-like particles, NIAID director Dr. Anthony Fauci told FiercePharma. Scientists can sequence a pathogen in a day or less and insert the genetic material into a vaccine platform “without ever having to grow the virus,” Fauci said.
In Zika, NIH scientists were able to enter human testing with a DNA vaccine just four months after sequencing the virus, cutting years off the development process. The government is testing its shot in phase 2 and could seek an emergency regulatory approval if another outbreak emerges, Dr. Fauci said.
Historically, preclinical testing took several years, according to the authors, followed by early clinical tests that take another few years. Efficacy testing and regulatory interactions could require another 10 years, they wrote, meaning it could take up to 20 years to develop a vaccine—and that’s if everything goes smoothly. Fauci said new technology could shrink the entire process to under five years.
Meanwhile, the Coalition for Epidemic Preparedness Innovations formed last year in response to the outbreaks and to better prepare for future outbreaks. The organization has raised hundreds of millions of dollars from the Gates Foundation and several governments.
This month, the coalition gave its first grant to Austria’s Themis to work on vaccines against Lassa fever and MERS. At the time, a CEPI spokesperson said “the fact that Themis has developed a versatile technology platform for the discovery, development and production of vaccine approaches is very attractive.”
“This means as well as focusing on MERS and Lassa we hope this technology will have value beyond those specific diseases,” she added.
By Eric Sagonowsky
Source: Fierce Pharma
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced several new measures to make it easier to run clinical trials in the country, marking the first time in 20 years the regulatory body has made such an overhaul.
Diabetes drugmaker Novo Nordisk is partnering with Dewpoint Therapeutics in a deal aimed at uncovering new treatments for insulin resistance by targeting cellular droplets known as biomolecular condensates. Dewpoint will receive $55 million upfront from Novo, which plans to develop small molecule drugs against targets discovered using Dewpoint’s technology.
Sanofi has secured approval for Dupixent (dupilumab) from the European Commission (EC) to treat severe atopic dermatitis in children aged six months to five years, who are systemic therapy candidates, in the European Union (EU). This approval makes Dupixent the first and only medicine available in the US and Europe for the treatment of such young children.
