- Hopes to get a vaccine to market are high, but doctors want expectations to be low for how quickly it can happen.
- Developing, testing and reviewing any potential vaccine is a long, complex and expensive process.
U.S. and international health officials are speeding work to create a vaccine for the deadly coronavirus spreading throughout Asia, which has already outpaced the 2003 SARS epidemic and killed at least 213 people in China.
Researchers will need to work fast. Since the first patient was identified in Wuhan on Dec. 31, the number of coronavirus cases has mushroomed to nearly 10,000 in mainland China alone as of Friday morning, up from roughly 800 the week before. While the new virus appears to be less deadly than the 2003 SARS outbreak, which sickened 8,098 people and killed almost 800, it is spreading significantly faster.
Hopes to get a vaccine to market are high, but doctors want expectations to be low for how quickly it can happen. Developing, testing and reviewing any potential vaccine is a long, complex and expensive endeavor that could take months or even years, global health experts say.
It took drugmakers more than a year to create a potential vaccine for the SARS epidemic, which was identified in November 2002 and killed nearly 800 people worldwide. By the time one was ready for human trials, the virus was pretty well contained. Since 2004, there have not been any known reported cases of SARS, according to the Centers for Disease Control and Prevention.
U.S. health officials are fast-tracking work on a coronavirus vaccine, hoping to start human trials within the next three months.
Even so, the fastest researchers could get a vaccine for the current outbreak to market would be a year, said Peter Hotez, co-director of Texas Children's Hospital Center for Vaccine Development, who helped develop a vaccine candidate for SARS. And that's assuming a best-case scenario where researchers immediately find something that works, the animal trials confirm it works and there are no complications in human trials.
"The problem is each vaccine is different. It's not like you can snap your fingers and make a treatment," Hotez said in a phone interview.
Before researchers can begin human trials, they must first have a firm understanding of the pathogen. Scientists are in the early stages of understanding the novel coronavirus but they do know its most important molecule is a spike protein, a multifunctional mechanism that allows the virus to enter the host, said Dr. Maria Bottazzi, co-director of Texas Children's Hospital Center for Vaccine Development.
"In the coronavirus — both the original SARS virus and Wuhan virus — it's called the receptor-binding domain of the spike protein," she said. "We, therefore, [would] use that as our ideal vaccine candidate."
The next step is a preclinical toxicology study that assesses whether a drug is safe to use and is tested on animals, Bottazzi said. That usually takes three to six months depending on the study's design, she said. If the evaluation is successful, scientists will then look to begin the first human trials, also known as phase 1 clinical trials, Bottazzi said.
"Those are usually done in normal, adult, healthy volunteers," she said. "It generally doesn't take more than maybe 20 or 30 people."
However, even if the scientists successfully get to an early stage trial, they could run into roadblocks during the vaccine development process that could extend the timeline for deployment. Bottazzi said there will likely be regulatory or operational obstacles, such as finding enough human volunteers. Then there are, of course, economic and financial hurdles, she said.
"What kind of business model? Who is going to pick up the cost?" she said. "Developing biologics can cost hundreds of millions or even billions of dollars."
Hotez said he ran into a funding roadblock when developing a vaccine candidate for SARS in 2011. The level of investor interest had been "remarkably little," he recalled, because the SARS epidemic was no longer a huge problem. This is an issue with the system, he said.
But thanks to SARS and success with the Ebola outbreak, some public health experts believe we could have a vaccine for the novel virus sooner than expected.
"We may have a vaccine in record time," former FDA Commissioner Scott Gottlieb said.
Lawrence Gostin, a professor and faculty director of the O'Neill Institute for National and Global Health Law at Georgetown University, said due to the advancements in science, it wouldn't surprise him to have a vaccine in hand within a few months.
"We are light years beyond where we were in biomedical technology than during SARS," he said. "The world has changed and all for the better."
There are currently no proven therapies for the latest outbreak, which authorities believe originated from a seafood market in China. Hong Kong researchers claimed Tuesday they have already developed a vaccine for the virus but warned that it will "take months" to test the vaccine on animals and another year to conduct trials on humans before it is ready.
While U.S. officials hope to start human trials on a vaccine in as little as three months, that timeline is optimistic, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, an agency within the Department of Health and Human Services. It could take a year or more before a vaccine is ready for sale to the public, he told reporters on a call Tuesday, adding that a phase 1 trial also does not mean "you have a vaccine that's ready for deployment."
The National Institutes of Health is working with biotech company Moderna to develop a vaccine using the current strain of the coronavirus, Fauci said.
"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."
Scientists are also looking at the 2003 outbreak of SARS, Fauci said, adding that "there could be some cross-reactivity" between the SARS virus and the new coronavirus "that could be utilized."
In addition to Moderna, at least a dozen drug companies, including Johnson & Johnson, are working to create a potential vaccine.
Dr. Paul Stoffels, J&J's chief scientific officer, told CNBC earlier this week that the drugmaker could create a vaccine in the coming months to fight against the fast-spreading virus. But he added it could take up to a year to bring it to market.
In the meantime, local authorities in China are using Gilead Sciences' antiviral drug Remdesivir, which was tested as a possible treatment during the Ebola outbreak, U.S. health officials said on the call Tuesday. Some authorities are also using antiviral drug Kaletra, developed by drugmaker AbbVie, on a "compassionate basis."