A vaccine against the new Wuhan coronavirus may start testing in as little as three months, according to National Institute of Allergy and Infectious Diseases Director Anthony Fauci.That’s fast.It took 20 months before a vaccine against severe acute respiratory syndrome, SARS, was ready for clinical trials.That doesn’t mean you can line up for a shot in three months. The vaccine will need to be tested for safety and efficacy. That will take months more.But the time it takes to go from outbreak to vaccine candidate is shorter than ever, thanks in part to a new kind of vaccine.A lab assistant works on samples with Christian Drosten, director of the institute for virology of Berlin’s Charite hospital on his researches on the coronavirus in Berlin, Jan. 21, 2020.Eighteenth century techEver since Edward Jenner developed the first vaccine in the 18th century, against smallpox, vaccines have worked essentially the same way. Patients get an inoculation containing a weakened or killed germ or some of its key proteins. The body’s immune system reacts to it, and the next time the germ shows up, the body can recognize and neutralize it.FILE – A staff member works at an egg testing workshop of Sinovac Biotech Ltd., a Chinese vaccine-making company, during the production of a vaccine for the H1N1 flu virus in Beijing, Nov. 19, 2009.Companies grow the germs or germ parts in chicken eggs or vats of live cells. Manufacturing enough vaccine-ready germs or proteins for millions of shots takes a year or more in big manufacturing facilities.In recent years, though, scientists have started exploring a different approach. Rather than injecting part of the germ itself, experimental vaccines deliver the genetic blueprints for germ parts and let the patient’s own body manufacture them.The active ingredient in these vaccines is DNA or RNA, the genetic instructions for building proteins.“You don’t even need an infectious virus,” said molecular microbiology professor Andrew Pekosz at Johns Hopkins Bloomberg School of Public Health. All scientists need is the virus’s genetic code. “And that became available very early in this outbreak,” he said.Vaccine design in three hoursChinese scientists first announced cases of unusual pneumonia Dec. 31, 2019. By Jan. 11, they had isolated the new coronavirus and published its complete genome.With the virus’s blueprints in hand, Inovio Pharmaceuticals designed a vaccine in three hours. Manufacturing started the next day.“It’s pretty remarkable, right?” said Kate Broderick, Inovio’s chief of research and development.Inovio’s vaccine is based on DNA. Two other companies, Moderna and CureVac, are using what’s called messenger RNA. If DNA is the master blueprint for a protein, mRNA is the working copy taken to the construction site. It’s what the body’s machinery uses to turn blueprints into finished products.FILE – Aedes aegypti mosquitoes are seen in a mosquito cage at a laboratory in Cucuta, Colombia, Feb. 11, 2016. An experimental vaccine for the Zika virus is to begin human testing after getting light from U.S. health officials.Both methods are easily adapted when a new disease appears. Inovio has a vaccine in clinical trials against Middle East respiratory syndrome, caused by another coronavirus. The company also is working on vaccines for Zika, Ebola, Lassa, HIV and others.DNA and RNA medicines also have the potential to treat cancer. Inovio, Moderna and CureVac are among the companies with genetic therapies in the works for cervical, lung, skin, prostate and other cancers.The technology has been around for about 20 years, Broderick said, but has made big advances in recent years. There are no human DNA or RNA medicines on the market yet, but there are several for animals, including treatments for West Nile virus in horses, a viral disease in salmon, melanoma in dogs and a gene therapy that produces growth hormone in pigs.Clinical trials and tribulationsWhile a DNA or RNA vaccine is quick to make, “what takes time — and it should take time — is the process of testing it,” Broderick said.After manufacturing, animal safety tests will take a few months. Then the first phase of clinical trials can begin. Phase 1 tests for safety in healthy volunteers will take three months, according to NIAID’s Fauci.After that, “some vaccines can get emergency approval for use in these epidemics,” Pekosz at Johns Hopkins said, “particularly if they’re the only means by which people can be afforded some level of protection.”Secretary of Health and Human Services Alex Azar gets a flu shot to during a news conference in Washington, Sept. 26, 2019.Once a vaccine is proved to be safe, researchers then must prove it works. That takes several months more.By then, the outbreak could be over. That’s what happened with SARS. By the time researchers got an experimental vaccine through phase 1 safety trials, old-fashioned quarantine had stopped the virus from spreading.“This is always the problem that we have with these outbreaks,” Pekosz said. Once the outbreak is over, “interest in generating the vaccine wanes, and the perceived need for the vaccine then wanes,” he added, “and these vaccines end up in this never-never land of being partially studied, but never pushed all the way through to completion.”And then another outbreak hits.“We could have done a much better job of preparing for this epidemic if we just followed through on some of the SARS vaccine work all the way to its completion,” he said.That’s a job government agencies should be doing, he said, “so that we do have data on how good a vaccine is before we actually need it.”
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The Latest:Q: “And about the death rate, I think I’ve seen that it’s like, you know, there’s just the raw numbers coming out of China. It’s about 2 percent, but that’s people who have been in the hospital right?”PEKOSZ: “Exactly! And so the big variable that we really just can’t quantify right now is how many people are getting sick with mild symptoms that don’t have them seek out health care? And how many actually don’t really have significant symptoms at all? And both of those numbers are going to be important for two things. One, like you said, it’s going to help us understand the true sort of fatality rate associated with this virus. And the second thing is that’s going to — knowing that number is going to help us understand how best to contain this disease in a certain — in the areas that it is right now.”Q: “So that’s interesting. So, you know, would you say that this is more or less concerning then, you know, then say a SARS?”PEKOSZ: “So right now I would I would probably rank it as a little bit more concerning than SARS, because it seems to be spreading in in a more efficient manner than SARS did. And even compared to MERS coronavirus, which has been in the news for the past few years as well. So it looks like it’s a virus that’s able to spread more easily, and that’s always a concern, because even if it’s a mild disease, right? It’s a new virus in the human population, so basically, everybody is susceptible. So if it does sort of become a global threat, even a mild virus, if it infects millions upon millions of people can induce pretty strong severe disease, and public health concerns.”Q: “Yeah, and then compared to the flu, especially this year’s flu, where does it rank compared to that?”PEKOSZ: “So far, it’s not as big of a concern as influenza has been this year.”Q: “Why do you think it is that the flu is obviously a much more serious, in terms of numbers and everything, but not as — you know, people’s hair isn’t on fire about this.”PEKOSZ: “Part of it I think, the fact that we hear about flu every year, and I think people get a little bit sort of desensitized to it. It’s one of the things they expect to see. And so they become a little bit complacent about, ‘Oh. Well, we expect to see flu.’ And so people start to think that this is the way, you know — this is an annual occurrence. There’s not much you can do about it. And therefore, I think the emphasis on doing things to prevent influenza isn’t as compelling to people.”Q: “Yeah. It’s interesting. So let me ask you a couple of things about what’s changed? And we’re talking about — OK, so we have a flu vaccine, but when SARS came out, you know, another brand new disease — reading in the 20 (inaudible). Colleagues at JAMA, they say it took about 20 months to get a vaccine into trials for SARS, and they’re saying it might be like three this time around. What has changed?”PEKOSZ: “I think there’s a couple things. One is we have our experiences from making vaccine candidates for SARS, and for MERS. So this group of coronaviruses, we have a good understanding of what it would take to make a vaccine that works against these viruses. So when SARS first came out, we had no idea of how to make a good coronavirus vaccine. So now we’ve built on all of the data that scientists have generated with SARS and MERS, and so we have a good idea. The second thing is the technologies for making vaccines have just made leap year jumps in terms of how easy it is to make some of these vaccines. Importantly, there’s been a real emphasis on what we call vaccine platforms. Which is, you know, a general way to make a vaccine that you can then plug in very specific proteins from different viruses to make a specific vaccine. And that technology has really skyrocketed recently and is very easy to utilize and make bar vaccines from.”
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