As the pandemic rolls on, researchers race to find answers
by Rachel Nania, AARP, May 1, 2020
In the case of the new coronavirus, a vaccine would make a person resistant to an infection from the virus and the illness it causes — COVID-19 — or, at the very least, make it so that a person who becomes infected has “a shorter course [of disease] or not as many complications,” Moody explains.
Who is working on a coronavirus vaccine?
Everyone — government scientists, biotech companies, university researchers — is involved in the effort to develop a coronavirus vaccine. It's a crowded field with nearly 100 different projects underway, but Kathleen Neuzil, M.D., professor in vaccinology and director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, says that's a good problem to have.
"Many more vaccines are going to fail than succeed, so you want a lot of shots on goal,” Neuzil says.
Another reason why it's advantageous to have so many institutions working on prevention efforts is because a pandemic, by definition, means this a global rather than national issue to resolve. “We are going to have a demand for a vaccine for over 7 billion people,” Neuzil says.
If more than one works, that's OK. Think of the flu vaccine, Neuzil says: There are multiple formulations on the market, including the injectable high-dose vaccine and the nasal spray vaccine, for example. If more than one coronavirus vaccine proves safe and effective, it might be that one works better in older adults while another is better for children.
"And as I said, we really need every person on Earth, theoretically, to be able to receive this vaccine,” Neuzil says. “So, to me, [having more than one option] is a positive, because we need so much.”
Will the coronavirus vaccine be made up of the live virus?
A handful of existing vaccines — including polio, chicken pox and measles, mumps and rubella (MMR) — contain a weakened version of the live virus that causes the disease. Because it's the closest thing to a natural infection, so-called live attenuated vaccines “are good teachers for the immune system,” the Centers for Disease Control and Prevention (CDC) explains.
Few research teams are taking this approach with the coronavirus vaccine, however, since “it takes a lot of time to be sure [the virus used in the vaccine] is weak enough that it doesn't cause disease,” Neuzil says. And in a pandemic, time is of the essence.
Instead, scientists are looking at different ways to introduce a piece of the virus to the body — whether it's a protein from the virus or a genetic code that the body can use to make its own protein to stimulate an immune response. Some are also studying the possibility of introducing the coronavirus by way of a vector, where a gene for a protein of the coronavirus, for example, is inserted into a harmless form of another virus and delivered to the cells. The advantage of this approach, Neuzil says, is that the vector-carrying vaccine “looks more like the real virus than perhaps just a piece of the protein does.”
"These are just different ways that we're trying to get at the same goal; we're trying to have the body make its own immune response to the virus,” Neuzil says. “Since this is such a new disease, we don't really know what's going to work the best for [the coronavirus], so we're trying a number of different approaches.”
When will a vaccine be available?
The answer to the question on everyone's mind — when will a vaccine be available? — varies depending on whom you ask. Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID) and a key member of the White House coronavirus taskforce, told NBC's Today Show on April 30 that he thinks it's “doable” to have a vaccine ready by January “if things fall into the right place.” Previously he had said it would be at least a year, likely longer, before we have a vaccine.
But even that time line is “optimistic,” says Amesh Adalja, M.D., an infectious disease physician and senior scholar at the Johns Hopkins University Center for Health Security.
The reason? Researchers need time to prove a vaccine is safe and effective in a series of months-long clinical trials before it is mass-produced and distributed throughout the world.
"And those processes take time because, you know, you've got to give people the full injection series, you have to follow them for long enough to see if there's an effect and it's got to be done in a setting where you can actually tell if people are protected or not,” Duke's Moody explains.
Can the process be sped up?
A number of coronavirus vaccine candidates are already being tested in humans in early phase 1 clinical trials. Previous vaccine research for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are also caused by coronaviruses, gave scientists a head start.
However, a big conversation taking place in the research community right now is what later phases of the trials might look like. Will the lengthy and rigorous process of data collection be followed, or fast-tracked?
"I think there is a chance that we won't see that traditional pathway” of three by-the-book phases, Moody says. Instead, there could be something akin to a “global phase 3 trial,” where millions of people are vaccinated with “a best shot” before all of the data are collected.
"We could debate how wise that is. But I think, you know, it's one of those things like if you're in the middle of a war, you kind of do what you've got to do,” Moody argues. “This is going to be an unprecedented situation where it's going to be really hard to wait the length of time that we all want to wait.”
The key, experts say, is finding the balance between speed and safety. In the case of the new coronavirus, some parts of the vaccine process can be accelerated, Adalja says. “But there is a lot of testing that needs to be done if you're going to make a vaccine that's going to vaccinate the entire world,” he adds. Because even a small adverse effect, when amplified on a global scale, can impact a lot of people.
Another part of the development process that can slow things down is production. It could take years to make the billions of doses needed to protect people from the coronavirus. However, Neuzil says, some drugmakers may be willing to take a risk and start making their vaccines before doses and formulas are finalized “so that the manufacturing part doesn't hold this up.” The approval process overseen by the Food and Drug Administration (FDA) can also be fast-tracked, but not skipped.
Does it usually take this long to develop a vaccine?
Though the time lines projected for the coronavirus vaccine may seem long and “frustratingly inefficient,” Moody says, in reality this process is moving at record speed. Vaccine development typically takes 10 to 15 years, according to a vaccine history resource created by the College of Physicians of Philadelphia. The fastest vaccine created thus far was for mumps; that process took four years.
"I think it's really important for people to understand that the response to this pathogen has been faster than any other pathogen in history,” Moody says. “The fact that you had a virus that was first reported in China in December, and by March we were already talking about setting up a phase 1 trial … I think the speed of the response, both by the medical community and by everyone else, is actually pretty astonishing.”
What if scientists don't come up with a vaccine that works?
That's also a possibility. Moody says that's why it's important to pursue therapeutics for COVID-19. Currently, there is no FDA-approved treatment available.
"If we had sort of the Tamiflu equivalent for coronavirus where you could be exposed and take Tamiflu and, you know, be protected, or you could get early disease and it could attenuate the disease or shorten the course, that would be great,” Moody says of the antiviral treatment for influenza. “There's a lot of work being done there. And I think all of that work needs to proceed as well.”
The National Institutes of Health (NIH) announced on April 29 preliminary results from an international clinical trial that showed patients severely ill with COVID-19 who received the antiviral drug remdesivir recovered faster than similar patients who received a placebo. More research is needed, but NIAID's Fauci called the findings “optimistic."
Once the vaccine is developed, will high-risk populations get it first?
"That's an interesting and also a somewhat complicated question,” Moody notes. The early phases of clinical trials are usually conducted in young, healthy people, and the population at highest risk for severe illness from a coronavirus infection includes adults 65 and older and people with chronic health conditions. So if trials are fast-tracked or certain phases are skipped, it could be risky to vaccinate the high-risk population without adequate testing first.
"If we get to a point where you have a vaccine that looks like it's effective but has a limited supply, then my expectation is it will probably end up going first to people who are on the front lines,” Moody says. “So health care workers, EMS, police, fire — all the people who are in situations where they've got to interact with the public.”
A major issue to consider, however, is that the definition of frontline workers extends beyond health care workers and emergency responders. Grocery workers, delivery personnel and public transportation employees are all essential workers who are also at high risk of exposure, Moody points out. “And how do you prioritize that? That's going to be a complicated discussion,” he says. “I don't know how well our society has done at having those conversations, but I think they are conversations we're going to have to have.”
Will the coronavirus vaccine be annual, like the flu shot?
It's hard to say at this point. So far, the new coronavirus has not shown signs of “rapid genetic change,” like influenza viruses, Neuzil says. That's why a new flu vaccine is needed every year. If that continues to be the case, a coronavirus vaccine likely wouldn't need to be administered on an annual basis. At the same time, Neuzil says she would be “surprised if a vaccine for a respiratory virus conferred lifelong immunity.” So it will probably fall somewhere in between.
"I usually remind people that we've only known about this virus not quite five months yet,” Neuzil says. “We are learning a lot.”
