On March 16, news outlets around the world reported hopefully on the administration of the first dose of an experimental vaccine against the coronavirus at a Seattle medical center. The novel coronavirus causes a potentially deadly respiratory disease called COVID-19.
That investigational vaccine, called mRNA-1273, has been developed by Moderna Therapeutics, and the clinical trial is being conducted at Kaiser Permanente Washington Health Research Institute Vaccine and Treatment Evaluation Unit.
Though this was the first investigational vaccine to begin trials in humans, it certainly will not be the last. Several other companies are also racing to create viable means of preventing COVID-19.
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Not All Vaccines Will Succeed
In a conference call for the media on March 18, Stephen J. Ubl, president and CEO of Pharmaceutical Research and Manufacturers of America, a membership organization representing pharmaceutical companies in the U.S., said that “not all potential vaccines will succeed, but there are several viable candidates.”
On that same call, Dr. Mikael Dolsten, chief scientific officer at Pfizer, said that “there is still much we don’t know about the source of this pandemic and the complexity of this novel virus. So, we understand that one company, one vaccine, one test or one medicine will not be an effective solution to overcoming the tremendous task at hand.” Rather, he added, the current crisis requires a “multi-pronged approach with a deep collaboration and partnership across the health innovation ecosystem.”
How Vaccines Come to Market
Although many companies and researchers are jumping into the fray to help fast-track development of a vaccine against the virus that causes COVID-19, there are certain limitations to how fast a viable product or products can be brought to market.
The Centers for Disease Control and Prevention notes that vaccine development is a five-stage process:
— Exploratory stage. In this earliest phase, vaccine manufacturers search for compounds that could combat an infectious agent or encourage the body to create its own immunity.
— Pre-clinical stage. During this phase, a candidate medication or vaccine is analyzed and tested in cells and later in live animals.
— Clinical development. The first human trials begin during this phase.
— Regulatory review and approval. If a medication or drug is proven safe and effective in clinical trials, the U.S. Food and Drug Administration gets involved to evaluate the vaccine and administer an approval. The International Federation of Pharmaceutical Manufacturers and Associations reports that, typically, 1 in 10 experimental vaccines make it all the way through regulatory approval.
— Manufacturing. Once the regulatory hurdles are cleared, the manufacturer can begin scaling up production.
— Quality control. This final step of the process ensures that the vaccine that has been produced meets quality standards.
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Each one of those steps can take years, and a potential vaccine can get stalled indefinitely at any one of them. Clinical development — the stage at which the experimental coronavirus vaccine is now being tested in Seattle — is only about halfway to the end goal.
And clinical development itself is a three-phase process that can take a long time. In phase 1, small groups of people are administered the trial vaccine. In phase 2, clinical study is expanded and given to people who have similar health and age characteristics to the vaccine’s intended population. And in phase 3, thousands more people are administered the vaccine to test efficacy and safety. Each step requires the one thing we don’t have a lot of with this pandemic: time.
There’s not a whole lot that can be done to speed up the process and still arrive at a safe and effective vaccine. Currently, most medical and public health experts say we’re at least 12 to 18 months away from having a usable vaccine against COVID-19.
That’s a best-case scenario, which has been boosted by the fact that in February, Chinese scientists sequenced the genetic code of the virus that causes COVID-19 and made that information available to researchers worldwide.
Because of the lengthy timeline associated with vaccine development, nearly three dozen companies and academic institutions around the world are now directing resources towards the search. As the IFPMA notes, the more “shots on goal” that can be taken in terms of types of formulations that are being tested, the more likely one of them will work.
To get these potential COVID-19 vaccines into human trials faster, some companies are shortening or eliminating aspects of the preclinical phase or conducting phases of the research in tandem that would normally be conducted sequentially, such as beginning trials in humans while testing in animals is still ongoing.
While these new approaches could speed a vaccine to market, it does raise some ethical questions about safety. It’s also unclear just yet whether the rush will result in an effective vaccine faster. Nevertheless, these efforts reflect the urgency surrounding developing a vaccine as quickly as possible.
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Using Technology to Speed the Timeline
Frances Zelazny, CMO of Signals Analytics, a data analytics company that helps pharmaceutical companies leverage artificial intelligence for drug development, says that although rigorous safety and efficacy testing takes time, technology and collaboration across the industry might help shortcut some of the lengthier steps in the vaccine development process.
“It takes an average of 12 years and billions of dollars to bring a new drug to market. For every 1,000 drugs that enter preclinical testing, only one will progress to human testing; and only one out of every five of those will ever get approved. Given the health emergency we are in, there is an obvious desire to speed up the process,” she says.
One way to speed up that process is for pharmaceutical companies to look at their catalogs of existing drugs and vaccines through the lens of artificial intelligence. “In the beginning of the process, the research usually involves searching through tons of sources of data to uncover opportunities that may not be so obvious.”
But with the development of artificial intelligence and super computers, this painstaking and previously human-driven process can be sped up by machines.
“Today, with big data drug discovery platforms, it is much easier to sift through sources of information like clinical trial data, patents, research papers, patient discussions and more, to uncover immediate insights that tell a company where to direct their resources. Then the actual development starts,” Zelazny says.
Pharmaceutical company Sanofi Pasteur, for one, is looking to a vaccine that has been in development for nearly two decades but never came to market as a possible candidate for addressing the COVID-19 pandemic.
Clement Lewin, associate vice president of research and development strategy at Sanofi Pasteur, said on the PhRma call that a vaccine it had been developing to combat a previous outbreak of SARS in 2002 ( a similar disease to COVID-19 that’s also caused by a virus) could have a “lot of promise,” and may be found to be useful in the current fight.
For the mRNA-1273 vaccine, Elizabeth Schainbaum, a senior communications consultant with Kaiser Permanente, says this “small, phase 1 test” is expected to take 14 months. “Our research team is recruiting 45 healthy individuals from the general Seattle-area community, ages 18 to 55, to participate.” The vaccine does not include any form of live virus, and the trial won’t expose participants to the virus, she noted.
The trial will assess “safety and antibody production, meaning that testing various doses’ safety and whether these doses are producing an immune response. This phase 1 trial is not studying the effectiveness of the vaccine in preventing coronavirus infection. That will come at a later phase of the research,” Schainbaum notes.
But the sense of urgency surrounding the need for a safe, effective vaccine to prevent COVID-19 is driving public health officials, private pharmaceutical companies and others to work as quickly as they can to find a solution. The sooner these vaccines and other medications can be tested, the sooner we might have a viable vaccine that can halt a global pandemic that shows few signs of slowing on its own. But right now, experts say that it will take at least a year and likely longer before such a vaccine is available.