Government scientists and pharmaceutical companies in Australia, China, and the U.S. are racing to develop a vaccine for the novel coronavirus that has infected over 6,000 people worldwide and killed more than 130.
But even if researchers come up with a vaccine—which a team in Hong Kong said it has already done—the drug would need to pass rounds of animal testing, human clinical trials, and regulatory approval before it can be released on the market, a process that will take several months at minimum and possibly up to several years.
A race against time
The chief scientific officer for Johnson & Johnson told CNBC on Monday that “dozens of scientists” at the pharma giant are working on a vaccine for the virus, and said the company is “pretty confident” it can produce one.
The Coalition for Epidemic Preparedness Innovations (CEPI), a public-private organization launched in 2017 to develop epidemic-preventing vaccines, announced last week it would fund work at two U.S. pharmaceutical companies, Moderna Therapeutics and Inovio Pharmaceuticals, along with the University of Queensland and the U.S. National Institute of Allergy and Infectious Diseases, to develop vaccines for the novel coronavirus, known as 2019-nCoV.
“Everybody is trying to move as quickly as possible,” said Jacqueline Shea, chief operating officer at Inovio, to the New York Times.
The new virus, which health officials suspect broke out at a now-shuttered wet market in Wuhan, is a member of the coronavirus family, which encompasses the common cold as well as rarer and more lethal viruses like severe acute respiratory syndrome (SARS) virus and Middle East respiratory syndrome (MERS) virus.
Existing data from the SARS and MERS outbreaks and familiarity with the spike protein characteristic of coronaviruses may help scientists develop a vaccine for 2019-nCoV. The experimental vaccine created by the University of Hong Kong (HKU) researchers, for example, was produced by modifying part of the existing flu vaccine.
But even if scientists come up with a vaccine, clinical trials and regulatory approval will likely push back the drug’s release date by a year or more. The HKU team did not give a specific time frame but said that animal testing could take months and human clinical trials could take “at least one year even if expedited.”
The Johnson & Johnson executive estimated it would take eight to 12 months for the company to reach the human clinical trial stage.
During the SARS outbreak—which killed almost 800 people and infected over 8,000 globally—scientists also set to work on creating a vaccine, a project slowed by the Chinese government’s initial concealment of the epidemic.
The scientists eventually created a SARS vaccine, but it was never released. By the time it reached the human trial stage, which took about 20 months, public health officials had contained the outbreak. A vaccine for MERS is still in development and has only been tested on animals so far.
“I think we are [in] uncharted territory in terms of a timeline, especially vis-a-vis regulatory approval, which under normal circumstances would take years,” said Edward Hammond, a Texas-based biotechnology researcher who has studied pandemic influenza preparedness.
“In the U.S. context at least, in order to have anything with formal approvals within a couple years, [government officials] will have to invoke emergency provisions.” Hammond added.
For any vaccine to be fast-tracked through regulatory channels, the U.S. government would have to declare a public health emergency, which would allow for an emergency use authorization of medical products from the Food and Drug Administration, according to FDA guidelines on the subject.
The Centers for Disease Control and Prevention said on Wednesday that the virus is “not currently spreading” in the U.S., and “the immediate risk in the U.S. is considered low.” The U.S. on Wednesday had five confirmed coronavirus cases.
As of Jan. 29, the number of recorded cases of the novel coronavirus surpassed 6,000. The majority of them are in China, where an additional 20,000 people are being observed for possible coronavirus infection.
Outside of China, countries across the globe have reported cases of the virus, including 14 in Thailand, seven in Japan, and four in France. Germany on Tuesday reported the first known case of human-to-human transmission of the virus. Taiwan and Vietnam have since reported human-to-human transmitted infections.
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