- Past research is helping speed up the search for a COVID-19 vaccine, but the approval process will probably still take 18 months to 2 years.
- Experts note that potential vaccines still need to go through a rigorous three-phase clinical trial process.
- Experts add that it’s important for the scientific community to “underpromise and overdeliver” on COVID-19 vaccines so they don’t raise the public’s hopes prematurely.
“We’re on the verge of great things; a new era of vaccinations. We’ve just scratched the surface of what can be accomplished.”
That’s how Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital, closed a TED Talk he gave last November.
Today, Levy told Healthline, that statement takes on elevated meaning as scientists like him around the world push to find a vaccination for COVID-19, the pandemic virus that has all but put the world at a full stop.
“We believe we are revolutionizing the way vaccinations are developed,” Levy said.
It’s important to note, though, as more labs announce concepts, plans, and vaccination formulas, that “soon” is a relative term when it comes to vaccines.
Despite positive reports from initial clinical trials, experts tell Healthline the best-case scenario for a vaccination delivered to market is probably 18 months to 2 years.
That may sound like too long, given the seriousness of the COVID-19 pandemic, but it’s quicker than the 5 to 10 years for many vaccines.
Levy said researchers around the globe are focusing on new methods, such as in vitro testing, and development that his lab does to speed up the research process.
“This crisis induces a lot of creativity,” Levy said.
He added there’s no competition between labs. They all want the same result.
“We hope we get scooped,” Levy said. “This is not a game.”
Developing a vaccine
Vaccines basically work by injecting a dead virus or another safe version of an illness into a person so their body attacks that “fake virus” and then has the antibodies available if a live virus invades.
Since then, scientists have tweaked and studied the process, looking for streamlining that doesn’t risk safety.
Thanks to discoveries made while working on the SARS (severe acute respiratory syndrome), MERS (Middle East respiratory syndrome), and swine flu vaccinations, researchers hope to streamline the discovery, development, and distribution of a COVID-19 vaccination, Levy said.
The process, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University in Tennessee, can be sped up but only by so much.
In the case of COVID-19, Schaffner believes new methods, as well as some prior work, could cut “up to 5 years off the process.”
But he warns, it will still take time.
“We cannot take shortcuts, but we can run faster,” he told Healthline.
In a classic case, Schaffner said, researchers work first to develop a vaccination in the lab.
“You create the product that you think will actually stimulate the human immune system to stimulate the antibodies that cut off the disease,” he said.
In the past, this was arduous, involving animal models and sometimes years of work.
Right now, he said, labs are benefiting from at least two things.
The first is a wealth of past research on coronaviruses and vaccinations.
The second is the publication of the COVID-19 genome by Chinese scientists to the world scientific community.
“Within hours (of that release) the [National Institutes of Health] was at work,” Schaffner said.
Honing in on COVID-19
Maria Elena Bottazzi, PhD, the co-director of the Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine, and her team are working full speed on developing a COVID-19 vaccination.
They’re basing much of their research on what they learned working on a SARS vaccination in the early to mid-2000s.
She told Healthline that it’s important to remember that a virus’ job isn’t to kill us.
Rather, its job is to find a way to use our bodies to survive.
In the case of COVID-19, the virus uses tiny spikes to attach to our cells as a “key” to open the cell door and let themselves in, where they can get what they need to reproduce.
Our bodies fight that invasion. Fever and other symptoms are a result of that battle.
Finding the right “army” for our bodies to stop those keys from opening those doors, Bottazzi said, is a complicated process that can take years.
However, since they’ve already amassed data on such spikes from SARS research, she feels they may be able to reduce the research window.
Her lab is working on a protein-based product.
Viruses start as DNA, move to RNA, and then to protein in the body, Bottazzi explained. Some labs are working at taking on the virus at those earlier steps.
Her team believes introducing the vaccination as protein is a more efficient choice. Why?
Because first, many successful vaccines, such as hepatitis B and the human papillomavirus (HPV) infection are protein-based, so there’s strong evidence showing that this approach works.
Also, Bottazzi said, manufacturers are adept at producing protein-based vaccinations quickly, cheaply, and in the billions.
A series of phases
A potential vaccine must go through a series of scientific trials.
The first step is a phase I study, which is what is
Phase I studies are small and involve only healthy people with low to no risk. This level of study only checks the safety of a vaccine, not its effectiveness.
Once a phase I trial is deemed successful, it can shift to phase II. That involves a larger pool of participants and focuses on both safety and immunology. Even at this phase, effectiveness isn’t studied.
Phase III is when effectiveness comes into play. An even larger pool of volunteers is used. Half are vaccinated and half are given a placebo.
With this double-blind trial, participants and doctors only find out afterward who was treated with the vaccine and who wasn’t.
As that goes on, a Food and Drug Administration (FDA) Data and Safety Monitoring Board, which Schaffner has served on in the past, has the sole responsibility of watching closely to ensure the safety of the volunteers.
They alone can see the data without blinders and pull the plug at any point. They can also look for effectiveness and, should it be obvious that’s not happening, they can end the research at that point, too, Schaffner said.
In a case where a drug is showing effectiveness in trials, manufacturers begin to gain interest and work at planning production.
All in all, this can take a decade from start to finish, but that might not be the case with a COVID-19 vaccine.
The race for a COVID-19 vaccine
Here’s what’s different now.
First, new techniques such as the in vitro practice at Levy’s lab among others have helped push things along.
Last week, University of Pittsburgh School of Medicine scientists announced a potential vaccine against SARS-CoV-2, the new coronavirus causing the COVID-19 pandemic.
When tested in mice, the vaccine, delivered through a fingertip-sized patch, produced antibodies specific to SARS-CoV-2 at quantities thought to be sufficient for neutralizing the virus.
The researchers were able to act quickly because they had already laid the groundwork during earlier coronavirus epidemics.
That background data, Schaffner said, helped speed up the road to phase I. Volunteers are now stepping up to be part of the study.
But, Schaffner warns, the public needs to be careful in reading such news. While headlines might feel hopeful, there are still many time-consuming steps ahead.
“There are certain parts that slow down,” he said. “Seeing what something does in the bloodstream is going to take at least 3 months and there is no slowing that down… Sometimes we can run rapidly around the track and other times we must slow down.”
Schaffner feels it’s OK for manufacturers to contract to begin production perhaps before the trials are complete, “so the public health community can be ready to deliver” the moment it’s possible.
“This whole thing can be done at breakneck speed, but we cannot cut back on safety,” he said.
He foresees a year and a half before a vaccine is widely available.
“We are working on a number (of solutions) simultaneously, so we are not putting all our eggs in one basket,” he said.
Levy agrees, saying the process could take up to 2 years and even that, he said, would be “unprecedented speed.”
Getting the word out — carefully
Experts say we need to be careful in how we describe a possible discovery.
Schaffner, who was a volunteer in the trials for the swine flu vaccination in 2009, remembers what happened when they overshot their estimates on a delivery date.
“Many things were done right and some were done wrong,” he said. “But we’ve learned.”
One big lesson?
“Underpromise and overdeliver,” he said. “Back then, we developed a successful vaccine, but the media story was, ‘The delayed vaccine is finally here.’ We need to not overpromise.”
While all the researchers are confident there will, in time, be a vaccine, they agree on staying focused on the work and issuing overly optimistic estimates.
“We have to have a level of humility here,” said Levy. “We are all very excited, but some things might not pan out. We’ve got a complicated challenge here. But the biomedical field we have today is far advanced.”
Bottazzi hopes that focus will be given to all 30 to 40 possible projects out there now, not only to find a COVID-19 vaccine but also to help build a catalog of information for the future.
“This is not the last outbreak we will see,” she said.
Source: Read Full Article