Scientists are racing to develop a vaccine for the new coronavirus, now called COVID-19, as the disease continues to spread in China and around the globe, but experts say vaccine development is a complex process that could take anywhere from several months to several years.
Reports of the new coronavirus first surfaced in early December 2019 in Wuhan, China. According to the World Health Organization (WHO), the main symptoms of the virus, which WHO on Tuesday officially named COVID-19, are fever and lesions in both lungs. Some patients also have reported difficulty breathing, WHO said.
As of Wednesday, health officials reported 44,653 cases of the virus globally, with the vast majority of those cases reported in China. Officials have reported more than 390 confirmed cases of the new coronavirus outside of mainland China, including 13 confirmed cases in the United States. Officials in China said there were at least 1,113 reported deaths linked to the virus as of Wednesday. A vast majority of the deaths occurred in mainland China.
Making a vaccine
For several weeks now, researchers have been working at a rapid pace to develop a vaccine for the virus. But Peter Hotez—co-director of Texas Children's Hospital Center for Vaccine Development, who helped develop a potential vaccine for SARS—warned that the public shouldn't expect a vaccine to reach the market for at least a year. "The problem is each vaccine is different," Hotez said. "It's not like you can snap your fingers and make a treatment."
When researchers set out to make a new vaccine, they first they need to understand how the virus is built. Currently, they know that an important molecule in the new virus is a spike protein, a mechanism that allows the virus to enter its host, according to Maria Bottazzi, co-director of Texas Children's Center for Vaccine Development, who also helped develop the potential SARS vaccine.
"In the coronavirus—both the original SARS virus and Wuhan virus—it's called the receptor-binding domain of the spike protein," Bottazzi said. "We, therefore, [would] use that as our ideal vaccine candidate."
Once researchers have developed a potential vaccine, a preclinical toxicology study is completed to determine whether the vaccine is safe to use. Next, it's tested on animals, a process that typically takes three to six months, Bottazzi said. If those tests succeed, scientists will start phase 1 clinical trials on humans.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said officials hope to start human trials in as soon as three months, though Fauci acknowledged that timeline is optimistic.
"It will take three months to get it into the trial, three months to get safety, immunogenicity data," Fauci said. "Then you move into phase 2. What we do from that point on will be determined by what has happened with the outbreak over those months."
Potential roadblocks—and a reason to be optimistic
According to Bottazzi, there are a number of roadblocks the vaccine could hit, including regulatory or operational difficulties, such as finding enough human volunteers for clinical trials. From there, drugmakers would have to determine the price of the drug.
Hotez said he ran into a financial roadblock while developing a potential SARS vaccine in 2011 because there was "remarkably little" interest from investors as the SARS epidemic wasn't as big of a problem at the time.
Hotez believes that was a mistake. "The frustrating part is, if the global community was less reactive and more anticipatory we could already have had this vaccine through clinical development and it would be ready to roll in China," he said.
Michael Osterholm, an expert on pandemics from the University of Minnesota, said the United States government needs to view vaccines for civilians "as a security procurement," similar to the military. "Every time we enter into one of these epidemics—SARS, MERS, Lassa fever, Zika … we hear, 'We're going to have a vaccine!'" he said. "The only one we have a vaccine for is Ebola" because the Department of Defense believed Ebola was a bioterror threat and continued funding vaccine development, Osterholm said.
But Richard Hatchett, who formerly worked in leadership roles at the U.S. Biomedical Advanced Research and Development Authority and CEO of CEPI, said he believes there will be interest to continue funding the efforts underway to create a vaccine for the new coronavirus.
"I've been talking to a number of … global multinational partners, all of whom are extremely concerned and interested in understanding how they can help," he said. "Nobody has said, 'Sorry, we're sitting this one out.' It's a question of what they can do, how they can help, what capabilities they have internally" (Lovelace, CNBC, 1/31; Branswell, STAT News, 2/6; Allen, Politico, 1/31; Joseph, STAT News, 2/11; WHO fact sheet, 2/11; New York Times, 2/12).