The first testing in humans of an experimental vaccine for coronavirus, also known as Covid-19, began Monday, the National Institute of Allergy and Infectious Diseases announced.
The main goal of this first set of tests is to find out if the vaccine is safe. If it is, later studies will determine how well it works. The trial was "launched in record speed," Dr. Anthony Fauci, the institute's director, said in a statement. Such rapid development of a potential vaccine is unprecedented, and it was possible because researchers were able to use what they already knew about related coronaviruses that had caused other diseases outbreaks, SARS and MERS.
Despite the rapid progress, even if the vaccine is proved safe and effective against the virus, it will not be available for at least a year. The tests, which are being conducted at Kaiser Permanente Washington Health Research Institute in Seattle, use a vaccine made by Moderna Inc.
Moderna uses genetic material – messenger RNA – to make vaccines. No vaccine made with this technology has yet reached the market. The infectious disease institute has been working with Moderna because the RNA approach can produce vaccine very quickly, said Dr. Barney Graham, the deputy director of the institute's Vaccine Research Centre.
Other companies, using different approaches, are also trying to manufacture coronavirus vaccines. Moderna is the first to reach a clinical trial. The participants will be followed for a year, but Stéphane Bancel, the chief executive of Moderna, said in an interview that safety data would be available a few weeks after the injections were given. If the vaccine then appears safe, he said, Moderna will ask the Food and Drug Administration for permission to move ahead to the next phase of testing even before the first stage is finished.
The second round of testing, to measure efficacy as well as to verify safety, will include many more participants. Moderna, with headquarters in Cambridge, Massachusetts, and a manufacturing plant in nearby Norwood, is already buying new equipment so that it will able to produce millions of doses. Bancel acknowledged that the company was taking a risk, because neither safety nor efficacy has been proved yet.
“Humans are suffering and time is of the essence,” he said. “Every day matters. We have taken these decisions to take the risk, because we believe it is the right thing to do.” – New York Times