Just weeks into the epidemic of novel coronavirus, reports of treatments and vaccines against infection with 2019-nCoV are causing pockets of excitement. The word that often isn’t mentioned is “experimental.” No drugs or preventives have yet been approved against the virus that’s infected more than 24,000 people — 99% of them in China — and killed close to 500. Scientists and companies plan to fill the vacuum with new tools for fighting the virus.
1. Why don’t we have a vaccine or drugs against 2019-nCoV already?
Coronaviruses, named for their crown-like appearance under a microscope, are a large family of pathogens responsible for diseases that range in severity from the common cold to severe acute respiratory syndrome, or SARS. The variant that emerged in Wuhan, China, however, had never been seen in humans before December 2019, so there was no call for drugs or vaccines until it began spreading around China and the world.
2. Why am I reading about treatments that work against it?
When faced with a new, serious disease causing fatal illness in hundreds of patients, doctors often try unproven treatments that they think stand a chance of working. This has been the case with Gilead Sciences Inc.’s remdesivir, an experimental antiviral drug, and AbbVie Inc.’s Kaletra, an HIV treatment that combines two drugs. When doctors note positive results, they often try to make them public so that others can try the same approach, and perhaps save lives.
3. Do those positive results mean a treatment is effective?
Not necessarily. Patients often recover from viral illness on their own, or improve because of other forms of supportive care such as rest and hydration. Some really sick patients might not respond to treatment no matter how effective it is.
4. How do scientists prove that a treatment is safe and effective?
That requires carefully structured and monitored tests known as clinical trials. Typically, these studies are designed to show that patients who get the drug do better than those who don’t, and that the results aren’t a product of chance. The trials try to subtract all the other influences and factors that might disguise the true effectiveness of the drug.
5. How long does that take?
It depends. Drugs that are already approved against one infection and shown to be safe can be tested for effectiveness against another in a matter of months. Experimental drugs may take longer to test, as they have to go through initial studies to evaluate whether they are safe. Other factors that can slow the process include the supply of drug candidates and the availability of patients to test them in. The trials also have to be approved by ethics watchdogs and drug regulators. According to a 2017 review, the median time for regulators to approve a new drug in 2015 was 333 days in the U.S., 422 days in Europe, and 639 days in China. China has since expedited its process.
6. What about vaccines?
Some of the world’s biggest companies are working on vaccines against the novel coronavirus, and the British giant GlaxoSmithKline said one could be tested and ready to use within 18 months if all goes well. Take that with a grain of salt, however. The 2003 outbreak of SARS provoked at least as much fear and disruption as 2019-nCoV has, and there still isn’t a vaccine. Because SARS is also caused by a coronavirus, having a vaccine against it would at least have given researchers a head start.
7. What if we need new drugs or vaccines ASAP?
When drugs are deemed to fill an immediate need, regulators can speed them through the approval process using a number of paths. A fast-track designation facilitates communication between drugmakers and regulators. A priority review sets an early target for regulators to make a decision on a drug.
