The National Institutes of Health (NIH) has fast-tracked vaccine development to stop a novel coronavirus emerging from China, but it will be months before it can be administered safely to an anxious public.
Anthony Fauci, MD, director of the NIH National Institute of Allergy and Infectious Diseases, described the ongoing research at a Jan. 28 press conference.
“We already started at the NIH, with many of our collaborators, the development of a vaccine,” he said. “One [vaccine] has a messenger-RNA platform. When the Chinese isolated the coronavirus they put the sequence on a public database. Given the technology of the 21st century, we are able to use that sequence, pull out the gene of the glycoprotein spike of this particular virus, and make that the immunogen to be used in a vaccine. Right now, it is being prepared.”
While promising, vaccine development and testing is a time-consuming process, both to ensure that it works and that it is safe in humans.
“I anticipate with some cautious optimism that we will be in a Phase I trial within the next three months,” he said. “I want to emphasize that does not mean that you have a vaccine that is ready for development. It will take three months to get it into the trial, then three months to get safety and immunogenicity data. Then, you move into Phase II. What we do from that point on will be determined by what is happening with the outbreak over that time.”
Considering that current trends find 2019-nCoV rapidly expanding in China and reaching other nations near and far, the general consensus is that the vaccine will be needed. “We are proceeding as if we will have to deploy a vaccine,” Fauci said. “We are looking at the worst-case scenario: that this becomes a bigger outbreak.”
Diagnostics and therapeutics also are in development, promising treatment until there is a vaccine to prevent infection. “With regard to diagnostics, the CDC has rapidly developed [a test] based on the published sequence of the virus,” Fauci said. “The NIH, along with the CDC, will be working on next-generation diagnostics more at the point of care so we can get them to more people throughout the world.”
Despite the prior emergence of SARS and MERS, there currently is no therapeutic treatment for coronavirus infection. Ongoing studies were initiated due to those outbreaks, but treatment remains elusive.
“Between those outbreaks and the current one, a number of antiviral drugs have been tested in vitro, in animal models, and even in the field anecdotally with historic controls,” Fauci said.
One of them is the antiviral remdesivir, which once was used in a clinical trial against Ebola, he said. Another that is now being used by some clinicians in China is a combination of two antivirals, lopinavir and ritonavir, Fauci said.
“I must emphasize there is no proven efficacy of these but they are being pursued together with a number of agents,” he said. “That is why it is so important that we get isolates of the virus, which we will soon have from the individuals in this country who have been infected.”
During the SARS outbreak, researchers developed monoclonal antibodies as a potential therapeutic.
“They were only used in vitro and in animal models,” he said. “Given the somewhat close homology between SARS and the new coronavirus, that could be utilized. However, what we are really trying to do — and it will happen soon as we get specimens from individuals who are infected — is to clone their cells and make specific monoclonal antibodies against this new coronavirus.”