The Lo Wu border crossing, which separates Hong Kong from the mainland metropolis of Shenzhen. The territory’s government said Monday it would close most of its border crossings with mainland China in an effort to contain the spread of the novel coronavirus, which has infected more than 17,000 worldwide and killed more than 360.
Since the emergence in December of the novel coronavirus 2019-nCoV, several drugmakers and academic institutions have risen to the challenge of developing vaccines and treatments. But while experts expressed concern about the rapid spread of the virus, they were optimistic that safe and effective vaccines and drug treatments could be found relatively quickly.
As of Monday, 17,391 people were confirmed infected worldwide, and 362 had died, according to the World Health Organization. All but 153 cases are in China, and it was only during the weekend that health authorities reported the first death outside of China, of a patient in the Philippines who was a close contact of the first patient in that country reported to have been infected.
London-based GlaxoSmithKline said Monday it would make its vaccine technology available to the Coalition for Epidemic Preparedness Innovations in response to the outbreak, while Johnson & Johnson Chief Scientific Officer Paul Stoffels told CNBC last week he was “pretty confident” the company could develop a vaccine as well. Others have also announced efforts of their own to combat the outbreak, which is centered on Wuhan, a city of 11 million in central China.
2019-nCoV belongs to the same family as the SARS and MERS coronaviruses, which respectively emerged in southern China in 2002 and Saudi Arabia in 2012, both resulting in hundreds of deaths. SARS has not been reported since 2004, while MERS is an ongoing problem. Nevertheless, despite numerous clinical trials, neither has an approved vaccine or drug treatment.
But interviewed experts had a more optimistic view of the outlook for 2019-nCoV.
“A lot has changed since SARS,” said Eric von Hofe, chief scientific officer of NuGenerex Immuno-Oncology, which is attempting to develop a vaccine using its own peptide-based technology. Two things that have changed, he said, are that the Food and Drug Administration is more willing than in the past to consider new technologies for vaccines, and there is greater acceptance of novel technologies like molecular clamps and RNA interference.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“The FDA in general has been more accepting of these novel technologies,” von Hofe said, in a phone interview. “They see an urgency.”
Those new technologies are what could make it easier to develop vaccines against 2019-nCoV easier than it was for the SARS and MERS coronaviruses, said Rachel Graham, an assistant professor of epidemiology at the University of North Carolina.
In terms of potential therapies for people already infected, Graham pointed to remdesivir, which Gilead Sciences originally developed for the Ebola virus. Graham was a coauthor on a 2017 paper in Science Translational Medicine that showed the drug, an injectable, has broad-spectrum activity against epidemic and zoonotic coronaviruses in mouse models.
On Friday, it was reported in The New England Journal of Medicine that a 35-year-old man in Washington state saw improvement in symptoms just a day after receiving remdesivir and had become asymptomatic except for his cough, which was also showing signs of improvement. The South China Morning Post reported Monday that multiple hospitals in Wuhan are now conducting a clinical trial of remdesivir.
“Talking about FDA approval, a year might be realistic,” Graham said in a phone interview, referring to Stoffels’ projection.
However, Graham added, several candidates are better-placed, when taking clinical trials and compassionate use protocols into account.
“I’d probably at least cut that in half,” von Hofe said, given the improved safety and rapidity of developing peptide-vaccines.
While peptide-based vaccines have sometimes proven too effective in animal tests, that can be improved by means like delivering them on different kinds of nanoparticles or RNAi-based particles, Graham added.
“Using different delivery systems is sometimes what makes the difference between vaccines working and not working,” Graham said in a phone interview.
Another trial that opened Monday at Wuhan’s Tongji Hospital is testing AbbVie’s HIV drug Kaletra (ritonavir, lopinavir) in 328 patients. Still, a paper published last month in Nature showed that remdesivir combined with interferon-beta showed superior activity against the MERS virus in vitro and in mice compared with Kaletra.
“Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV,” Gilead Chief Medical Officer Merdad Parsey said in a statement Friday. “We are also expediting appropriate lab testing of remdesivir against 2019-nCoV samples.”
Graham and Sarah Leist, a UNC postdoctoral fellow and coauthor on the Nature paper who was on the same call, said another cause for optimism is that social media have enabled better communication between researchers about advances in therapy and prevention and the current conditions on the ground.
“It’s our common goal to get a hint of all this as fast as possible,” Leist said. For example, one Chinese scientist has been providing translations of news articles, she said.
One challenge is misinformation, particularly that which paints science as diabolical, Graham said, pointing to a paper that had led to debates about whether the coronavirus may have been engineered. The paper in question, which had been published on a site for research that has not been peer-reviewed, has since been withdrawn.
“It’s important to understand that scientists are working as hard as we can to figure out which vaccines will work, as quickly as possible,” Graham said.
Von Hofe also said that while there is a greater appetite for novel technologies, they have not been vetted and may ultimately not work.
“The newer a technology is, the greater the chance it will not work simply because it has not been tried before,” von Hofe said.
For now, all three experts said their biggest concern is 2019-nCoV’s ease of transmission and rapid spread. The WHO estimates that its R0 – or R-naught, which measures the number of people who whom an infected person can spread a pathogen – is 1.4-2.5, while some Chinese scientists estimate it’s as high as 3.6-4. By contrast, a 2014 meta-analysis showed that the seasonal flu has an R0 of about 1.28, while the 1918 pandemic flu’s was 1.8.
Consequently, they said, the actual number of infected people is likely much higher than the WHO’s official estimate – probably in the range of 100,000 – as the official number reflects people who have been diagnosed in medical facilities. “There is a possibility of people being asymptomatic, and those cases wouldn’t be reported,” Graham said.
Photo: Anthony Kwan, Getty Images
