- Some government and business officials are expressing hope that a vaccine against COVID-19 could be ready as early as January.
- Experts say that goal is quite optimistic given the testing, manufacturing, and distribution that usually accompanies a new vaccine.
- They do note that the genome sequencing for the new coronavirus has been done and a number of companies are doing research on a vaccine now.
- They also note that some companies have agreed to begin manufacturing before clinical trials are completed.
The timeline to develop a safe, effective vaccine to fight a virus is typically counted in years — or even decades.
But with the COVID-19 pandemic affecting millions around the world and killing hundreds of thousands of people, the race is on to produce a vaccine faster than ever before.
President Donald Trump has said a vaccine could be available by January, which would be an unprecedented development cycle.
But how realistic is that?
Experts say the goal is possible — but not likely.
“This is a highly ambitious goal and, although a possibility, it far exceeds any vaccine development timeline in the past,” Dr. Larry S. Schlesinger, an infectious disease specialist and the chief executive officer and president of the Texas Biomedical Research Institute, told Healthline.
“Several steps done in parallel can cut some time (e.g., starting manufacturing vaccines during early clinical studies),” he said, “but the fundamental steps that need to be taken through clinical trials and animal studies take time and cannot be short circuited when working to create a safe and effective vaccine that will be used worldwide in different types of people of different ages.”
There are a few factors working in favor of the possibility that we could have a COVID-19 vaccine sooner rather than later, even though experts are quick to note that the previously cited 12 to 18 month time frame would be the historical fast track.
The first is that while vaccines for other coronaviruses, including SARS and MERS, were never finally developed, the research done into understanding these viruses helped create the platform from which scientists could begin to understand COVID-19.
For instance, it took 4 months to sequence the genome for SARS in 2003. It took less than a week for researchers in China to sequence COVID-19 in early January, the South China Morning Post reported.
Another factor is that there are nearly a dozen COVID-19 vaccines in development around the world.
Of these, four or five look promising, with two set for large-scale testing by July, according to Francis Collins, director of the National Institutes of Health.
The more teams there are working on vaccines with varied approaches worldwide, the greater likelihood one of them is successful.
“It’s not just one scientific concept that’s being pursued. All roads lead to Rome and there are a number of different roads being pursued,” said Dr. William Schaffner, a professor of preventive medicine in the Department of Health Policy and professor of medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine in Tennessee.
“The best result is that we get several different vaccines out there, all of which work. The worst is that none of them work. But probably we will be in the middle somewhere,” he said.
Manufacturing capacity is another important aspect of how teams are approaching COVID-19 vaccination.
Typically, it would be a financial gamble to put a not-fully-tested vaccine into production. If it doesn’t work or is proven unsafe in clinical trials, the newly manufactured stock is useless and any investment is lost.
But with COVID-19, governments and manufacturers working in concert have decided that it’s worth producing a potentially unusable product if the vaccine comes to market more quickly.
That’s a large shortcut in typical vaccine development because it bucks a profit-and-loss equation in favor of the common good.
“Under conventional circumstances, you start the manufacturing process after it gets licensed [by the Food and Drug Administration],” Schaffner told Healthline. “But what’s happening here is that the United States government is making or will make an investment in actually starting to produce the vaccine in quantity before the final effectiveness trial is finished.”
“In order to help people early, you’re putting the money on what you think is the fast horse,” Schaffner said. “If the vaccine doesn’t work, then you have to throw all that vaccine out, you’ve wasted all that money, but the thought is, it’s only money. Let’s get this vaccine done because we can save lives.”
Finally, in addition to signing up volunteers early for regular vaccine trials, some companies are lining up “challenge trials,” an ethically controversial program in which human volunteers agree to be willingly exposed to the virus and risk injury to test the effectiveness of a vaccine.
“Challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity,” noted researchers in the Journal of Infectious Diseases.
So far, there have been some promising early results and optimistic claims.
A clinical trial currently ongoing at Oxford University in the United Kingdom promises 30 million doses of the vaccine by September if human trials are successful.
An animal trial — a collaboration between the National Institutes of Health and Oxford University — of a different vaccine tested in macaque monkeys appears to have protected the apes against COVID-19, paving the way for a human clinical trial.
But perhaps the biggest headline in recent weeks has come from the drug company Moderna, whose COVID-19 vaccine reportedly produced antibodies in 45 participants.
Those antibodies could offer protection against the virus, although it’s too early to tell whether this treatment offers the protection of a fully tested vaccine.
Some experts have thrown cold water on Moderna’s announcement, noting that the company has withheld key information needed to interpret that data correctly, including the ages of the participants and the results of other patients in the study, according to STAT News.
Of note, the National Institute for Allergy and Infectious Diseases, which partnered with Moderna on the vaccine and created the prototype, has remained mum.
That example highlights a gap between what many want — a speedy, effective vaccine — and the cold realities of vaccine development.
“There’s a saying in research that there are a thousand ways to do an experiment wrong and that’s especially true in clinical research,” Dr. Henry I. Miller, MS, a senior fellow at the Pacific Research Institute, told Healthline.
“For one thing, the vaccine candidates might not actually work, or they might increase the virulence of a post-vaccination infection. Or the immunity could be too transient to justify vaccinating three billion people,” he said.
And those are just a few of the factors that could halt or inhibit successful development.
“There is a likelihood that the lead vaccines work in some people with some level of protection, the so-called prototype vaccines, but will not be optimized,” Schlesinger said. “This will slow the timetable to further develop the right dosing, route of administration, and knowledge regarding the timing of so-called booster shots that will be necessary for a sustained effect of the vaccine.”
“Based on the history of making vaccines, there are often stumbling blocks regarding safety and efficacy that markedly slow down the process,” he added.
In short: Stay optimistic, but be prepared to settle in for the long-haul.