So far, three major COVID-19 trials have hit pause on their operations. Experts say, however, that this isn’t something to be alarmed about, and it doesn’t mean they’re shutting down for good — or that we're doomed. In fact, the experts I spoke to seemed pretty hopeful about the future of the COVID-19 vaccines.
Here's the background: On October 13, Eli Lilly announced a standstill of their trial of a monoclonal antibody treatment for the novel coronavirus — similar to the one President Donald Trump took for COVID-19 — due to possible safety concerns. The day before, Johnson & Johnson noted they were temporarily pausing their phase 3 vaccine trial due to an unexplained illness in a study patient, the company said in a release. Independent safety monitoring committees are investigating both cases. This comes just a month after the pharmaceutical giant AstraZeneca stopped their trial after two participants developed an unusual neurological condition. Although that trial is back up and running in the UK, The U.S. Food and Drug Administration hasn’t allowed the trial to resume in America yet, CNN reports.
It’s very common for late-stage trials for vaccines and drugs to be halted briefly for safety reasons. “When you’re giving the vaccine, you’re giving it to a population of people who are healthy, so there’s a high threshold for safety,” says Amesh Adalja, MD, a senior scholar at Johns Hopkins Center for Health Security. “These pauses are an example of the system that’s in place working well.” The fact that we’re hearing about these pauses is also, in a way, a good sign, he says. It means the trials are operating ethically.
"These are huge trials with 30,000-plus participants," notes Kirsten E. Lyke, MD, who’s the lead researcher on the Pfizer/BioNTech vaccine trial and investigator on the Moderna and Novavax trials. "When you have that large amount of people, there’s going to be random events that occur that are unexplained. Unexplained events trigger halts, which is expected.”
“This is not unusual, it’s just that no one normally watches vaccine trials the way they’re watching the COVID trials,” adds Dr. Adalja, regarding late-stage vaccine trial pauses.
For now, minimal information is available about the nature of the illnesses the participants are experiencing and, in the case of Johnson & Johnson, it’s not yet been announced whether the ill trial participant received the actual vaccine or a placebo.
Whenever a patient presents unusual or concerning symptoms during a trial like this, an independent advisory committee — in Johnson & Johnson’s case, the the ENSEMBLE independent Data Safety Monitoring Board (DSMB) — will jump in and dig into the case in an unblinded fashion that won’t disrupt the trial, explains Dr. Lyke, an infectious disease expert and professor at The University Maryland School of Medicine’s Center for Vaccine Development and Global Health. They can look into whether the ill patient got a placebo or not, and make their determination from there. “It can be very easy to determine whether [the illness] is not related [to the trial] if the patient got a placebo. Or it could be that it’s actually an event that has no relationship to the vaccine, but just randomly occurred and would have whether or not they were enrolled in the trial. Or it might be concerning enough that there’s a reasonable expectation it is connected to the trial.” That’s where things get tricky, Dr. Lyke says.
“Let’s just say you’re feeling great, you sign up for the COVID-19 vaccine, and a month later, you suddenly get diagnosed with, let’s say, multiple sclerosis,” Dr. Lyke says, as a hypothetical. “You could say, ‘Hey, I’ve never had this before, it must be related to the vaccine.' Or you could say, 'Out of every 40,000 people that you follow for six months, on average, at least one of them might develop multiple sclerosis.'”
Johnson & Johnson pointed Refinery29 to their press release when asked for comment. Eli Lilly has not yet responded to Refinery29's request for comment.
Dr. Adalja says he doesn’t believe that the pauses will have a major impact on the vaccine timeline. Currently, experts seem to believe that if all goes well, we may have a efficacious vaccine as early as December, and we’ll be able to offer widespread vaccinations by mid-2021.“The fact is, we have more than one vaccine candidate in clinical trials right now, which helps to ensure at least one of them makes it through to emergency use authorization.” Right now, researchers are testing out 45 vaccines in clinical trials on humans, and 91 are under active investigation on animals, according to The New York Times vaccine tracker. Eleven clinical trials are in phase three (China and Russia have approved vaccines for limited or early use without waiting for the results of phase 3 trials, The New York Times notes).
Meanwhile, Dr. Lyke argues that the timeline for the road to a vaccine could be set back a bit while these trials wait for the go-ahead to get back up and running. But she still thinks many people will be able to be vaccinated by fall 2021. “These studies that halted are not the only hope — but they’re a big chunk,” Dr. Lyke says. “One or two companies having a pause is not a big deal, I believe they’ll be able to restart… But you don’t want to see pauses in every major company developing a vaccine. But I don’t think that’s going to happen.”
Dr. Lyke says she has faith that in the next year we’ll have a vaccine that is safe and effective. Although 35% of Americans said they don’t trust how quickly the novel coronavirus vaccine clinical trials are moving, according to a poll from Informa Pharma Intelligence and YouGov, Dr. Adalja asserts that the trials are operating safely. It’s not that the trials themselves have been moving faster amid "operation warp speed," it's been the administrative aspects of getting into trials and the manufacturing process. “That’s where the time was taken off, the clinical trials are progressing at the usual expected pace,” Dr. Adalja says. “Now, what’s going to be important, is that the process that the FDA puts these vaccines through is not something that’s subject to the White House interfering with.” But that’s another can of worms.
What you need to know is that these pauses are a sign that the ethical safeguards in place are working, and that researchers seem to be doing what they should be. “There’s always going to be a group of people who don’t trust the vaccine, but we’ve been pretty consistent that the reason things are moving so quickly is not because we’re compromising the timeline of the vaccine, it’s all on the administrative and productive end,” Dr. Lyke says. “Yes, the timeline has moved up, but that has nothing to do with safety.”
And in general, Dr. Lyke says that the news of the vaccine pauses hasn’t stopped her from hoping about a post-vaccine world. “It’s pretty incredible where we are right now,” she notes.
“I don't think that these first generation vaccines are going to erase the problem of COVID-19,” notes Dr. Adalja. “It’s not going to completely eliminate COVID-19 as a total public health threat but it’s going to tame it a lot. It’s not like it rewinds us back to January 2020 [in the U.S.], but we will get to do a lot more things safely.”
The bottom line? “I wouldn’t assume that we’re doomed,” says Nate Favini, MD, medical lead at Forward, a concierge medical service. “The Novavax, Moderna, and Pfizer vaccines are all in Phase 3 trials and we should have results from those trials by the end of this year or by early next year. As of today, we haven’t seen any safety issues in these trials, but the purpose of these trials is to identify those issues. I would start to worry if we don’t have a workable vaccine by spring 2021.”