As they rush to test an experimental coronavirus vaccine, experts aren’t holding out to see how well it inhibits infection in animals prior to testing it on people, ignoring the usual protocol.
This isn’t the normal process of a vaccine evaluation. Vaccine Regulation Guidelines from CDD require that a manufacturer show a product is safe before it goes into people, and while it isn’t enshrined in law, research workers typically check that a new concoction works well in lab animals before putting human volunteers at potential health risk. Usually vaccine development requires more than five years and sizeable capital investment. This prolonged course of action has created problems in the past, for example with Ebola.
“I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial,” says Tal Zaks, chief medical officer at Moderna, a Cambridge, MA based biotech that has produced a Covid-19 vaccine candidate at record speed. He claims that scientists at the National Institutes of Health are “working on nonclinical research in parallel.” Meanwhile, the clinical trial started recruiting healthy participants in the first week of March.
Professionals know that it’s crucial to see how well a new vaccine can stop disease in animals, but to him, given the existing pandemic crisis, it feels right to start human safety testing before those clinical tests are finished.
The vaccine, which relies on custom-built messenger RNA to produce an immune response, will be tested first on 45 healthy volunteers and then will likely undergo two more phases of testing on many more people, he said. Regardless if all goes well, it would still take time to clear regulatory hurdles and to manufacture enough vaccine to inoculate millions.
Assess, that the 2002 outbreak of an older coronavirus, severe acute respiratory syndrome, or SARS, in China, led to a timeline gap of 20 months for NIAID to commence the first phase of human vaccine testing.
Moderna, which went public in December 2018 and raised $600 million in the most significant initial public offering in biotech up to that period, isn’t the only drug maker wanting to create a shot for the novel coronavirus.
“Everyone wants Moderna to succeed because it could be important technology,” Dr. Hotez said, codirector of the Texas Children’s Hospital Center for Vaccine Development, although he characterized the news about Moderna’s delivery of the first possible vaccine to NIAID as “a bit of hype”.
Right now, human beings’ greatest advantage might be the speed with which the vaccine is developed. The virus behind the outbreak that began in Wuhan, China, was identified on Jan. 7. Less than a week later — on Jan. 13 — researchers at Moderna and the NIH had a proposed sequence for an mRNA vaccine against it, and, as the company wrote in government documents, “we mobilized toward clinical manufacture.” By Feb. 24, the team was shipping vials from a plant in Norwood, Mass., to the National Institute of Allergy and Infectious Diseases, in Bethesda, Md., for a planned clinical trial to test its safety.
Similar to several biotechs in the state’s flourishing life sciences sector, Moderna hasn’t yet launched a product to market ever since the company started 10 years ago. And Moderna’s CEO accepted that being successful with the approval & endorsement of the coronavirus vaccine is barely a foregone conclusion. Yet, he does appear confident about its prospects.
The potential benefits should be to have a vaccine against Covid-19 ready for general use at the earliest opportunity. That won’t happen for a year at least. That chronology, according to researchers, is “insanely fast,” but it probably won’t be fast enough to help slow the current outbreak.
To vaccine-makers, though, Covid-19 may well just be a test case for other future outbreaks.