- Understanding how the COVID-19 vaccines were developed so quickly can help ease fears about them.
- Resources, public support, existing technology, and more all contributed to the speed of vaccine development.
- Lessons learned during COVID-19 vaccine developments might help with future vaccines.
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The quick development of the COVID-19 vaccines is unprecedented and an encouraging step toward putting an end to the pandemic.
However, the expedited process has created concerns for some people who have a hard time believing that effective vaccines could be produced in such a short amount of time.
Since understanding how and why this was done can help demystify several details and ease fears, we break down key aspects of the development process and explain how this achievement was made in record time.
Because COVID-19 became a pandemic, Lynlee Burton, head of center for vaccines and emerging infectious diseases at PRA Health Sciences, said governments and companies put resources toward prioritizing COVID-19 treatments and vaccines.
“There was a lot of money that was freed up and moved to the places where research was being done,” Burton told Healthline.
In addition, enrollment for trials that require the number of people that the COVID-19 trials did usually take years. However, these trials filled up fast.
“The public was rooting for us. When we started to enroll trials, there was lots of interest, so we had an easier time maybe than standard in terms of enrollment,” Burton said.
Dr. Kathleen Jordan, infectious disease specialist and senior vice president of medical affairs at Tia, agreed.
She said the prevalence of COVID-19 allowed the trial period to be short.
“[In] only a few months the numbers could show efficacy as placebo arms quickly evolved as being inferior. In less common diseases, it takes years for enough people to be affected in either arm to show the difference, so trials usually require much longer observation periods for the incidence to be statistically significant,” Jordan told Healthline.
Before the new coronavirus, SARS-CoV-2, arrived and started causing COVID-19, there was much research done on similar coronaviruses called SARS and MERS.
“The University of Oxford had begun work on SARS, and so when SARS kind of went away and didn’t turn into a global pandemic, the research kind of stopped on that vaccine,” Burton said.
The previous research gave scientists a head start on COVID-19 research.
Additionally, the Coalition for Epidemic Preparedness Innovation (CEPI) was formed due to the Ebola outbreak in 2015.
CEPI is a global partnership between public, private, philanthropic, and civil society organizations that works to accelerate the development of vaccines against emerging infectious diseases.
“[Ebola] made it very clear that as a world, we were not ready for a pandemic. If Ebola had been worse, we would not have been able to respond, and CEPI was formed out of that. There was already strategies in place for responding to an epidemic,” Burton said.
Both the mRNA and adenovirus technologies behind the COVID-19 vaccines were built on decades of research and experience.
“The scientific community wasn’t starting from scratch. Adenovirus and mRNA technology has been used in humans for decades. These are not new technologies. It’s mature, safe technology that was tailored and employed to fight this pandemic,” Jordan said.
In fact, Burton added that Moderna has been working strictly on mRNA for years.
“From a technology perspective, what’s really interesting is in late January [2020], we were able to [detect the genome sequence of COVID] and put it on the internet, and researchers around the world had access to it, and that is unprecedented,” Jordan said.
To conduct a clinical trial, Burton said it typically takes anywhere from 2 months to a year of administrative work — submissions, answering questions from regulatory agencies — before the actual trial can begin.
“[What] happened with the regulatory agencies across the world is that they were able to prioritize COVID studies, and as soon as they came in, they… reviewed them and brought on additional staff in order to process it,” Burton explained.
They also instituted rolling reviews, which means pharmaceutical companies were able to provide regulatory agencies with data as they received it on an ongoing basis throughout the trials rather than waiting until the end of the trials to send all the data they collected at once.
Isaac Rodriguez-Chavez, PhD, senior vice president and head of global center of excellence for decentralized clinical trials at PRA Health Sciences, said rolling reviews have been used for other indications.
“This is a public health emergency situation, so under these conditions it is pertinent for the regulatory agency to [use] this kind of mechanism,” Rodriguez-Chavez told Healthline.
By doing so, Jordan said, “It’s important to realize that the scientists did not make risky shortcuts on the actual science and followed usual scientific design. It’s just that enrollment and outcomes were quick, and committee hearings and data reviews were prioritized.”
Burton pointed out that vaccine researchers across the world worked around the clock, putting trials together, reviewing data, and programming the ability to review data.
“There are so many people who have worked so hard that we don’t always know about,” she said.
Burton also credits luck, because it typically takes 10 to 15 years for a vaccine to come to fruition.
“I think the fastest was mumps… a workable vaccine was established very quickly, but it didn’t work very well and it took some time in order to get to one that worked better,” Burton said.
“Here, we got lucky. The messenger RNA came out with amazing efficacy, and that is something we have to say, you know what, this was no HIV, this was a coronavirus that we were able to easily identify a vaccine that worked quickly. So all in all we had an unprecedented response from the world and we also had a little bit of luck,” she said.
The COVID-19 vaccines that are currently available in the United States were granted emergency use authorization from the Food and Drug Administration (FDA). They’re not fully approved.
“The reason that there is not a full licensure given to the vaccines is essentially because we have very limited time in understanding… the mid-term and long-term benefits of the vaccine in the individuals that were vaccinated,” Rodriguez-Chavez said.
This isn’t cutting corners. Rather, it’s an extensive standard review process that is expedited, he said.
Regulatory agencies in the world look at two things:
- The safety of the participants and that they wouldn’t be compromised under an emergency use authorization.
- The data quality and data integrity of any submissions to the agencies.
“The standards could never be compromised even under an emergency authorization use of the vaccines; the data integrity is there and the safety of the participants is paramount,” Rodriguez-Chavez said.
Burton pointed out that in the fall of 2020, the Moderna, Pfizer-BioNTech, and Johnson & Johnson vaccine trials all paused due to a safety signal.
“[The] truth is, that is part of the clinical trial process… we have people watching for any sign or symptom from the individuals that are in the trial, and the fact is that when we see something that meets the criteria, we [pause] the study… It’s integral to the design of every single study and shows that the process is working,” she said.
The reason resources were upped to make COVID-19 vaccines so quickly is because of how many people developed the disease.
“Remember, you need high infection rates to shorten the period of time being studied,” Jordan said. “I do think, however, that we realize now that the world needs to invest into vaccine development on the whole as a powerful tool in keeping the world healthy.”
Rodriguez-Chavez believes the speed of vaccine development will be determined on a case-by-case basis.
But he thinks lessons were learned here, especially when it came to aligning different elements that go into vaccine development, including science, medicine, regulatory processes, policies, logistics, and financial support.
“All those elements were aligned because of the nature of the emergency. What we need is an alignment of those different sectors of society, and we have learned that we need to work together more than ever if we are to develop vaccines going forward,” he said.
The financial risk associated with the COVID-19 vaccines may not be something repeated often, Burton pointed out.
“[All] the countries began manufacturing vaccine for use at risk, so as soon as they had a product in clinical trials, they started manufacturing large quantities, which is something that’s never done. They don’t take that risk, and that comes with the resources that were freed up for this pandemic,” Burton said.
One area Burton thinks might be used going forward is technology related to the logistics of gathering information during clinical studies.
“We had lockdowns. We had some guard rails up in terms of seeing people in person, so we were able to utilize technology that we already had in place like electronic diaries,” she said.
“We were able to take some of that infrastructure we had in place that wasn’t always used to the fullest extent as it could on COVID trials, and we’re seeing that it works and it collects even higher quality data quicker,” Burton said.
The high worldwide rates of people with COVID-19 initiated a joint effort in putting public and private resources toward finding a vaccine.
People’s interest in joining studies also played a part, as well as the availability of existing science and technology.
“I would acknowledge that the concern over vaccine safety stems from trying to make the right decision for themselves and their loved ones — what we all want. With infection rates like we have seen in the last year… I strongly recommend choosing what it takes to avoid infection, as with vaccines and other prevention measures,” Jordan said.
While COVID-19 is complex, she noted the choice to vaccinate is not.
“Will we put up with sore arms, maybe even 1 to 2 days of fatigue and aches, to save tens of thousands lives, perhaps even our own? I’ll take a sore arm any day. I have seen many people die of COVID-19 and no one die from vaccination,” Jordan said.