ANSWER:
The short answer is: Yes. None of the science was skipped but the additional financial investment, focused attention and international collaboration helped fast track a lot of the administrative barriers.
Here is the longer answer:
Development
Normally, years can be spent advocating for a new intervention, compiling foundational research, seeking funding, recruiting people for clinical trials, getting the approvals in place, and dealing with all of the administration that goes along with the work.
With COVID, all the critical steps, such as the underlying science, and the clinical trials where the vaccines were tested on animals and people who agreed to participate, all happened as they needed to.
But here are some reasons it was faster than usual. With the COVID19 vaccines, we were not starting from scratch. While this coronavirus is new, it’s not the only one we’ve dealt with. There are hundreds of coronaviruses – we’ve studied them, and we’ve responded to them before. It only took about two weeks to map the genome of COVID-19, and that told us what kind of vaccine would need to be developed to stop it.
The scale of international partnership and collaboration was unprecedented – there were and still are numerous vaccines in development all at the same time, being led by different companies, in different countries, using different types of vaccines.
Normally, this would not be possible due to the financial risks. With COVID, governments took on the financial risk and told the companies that even if their vaccines needed to be thrown away because they didn’t work, they would still be compensated for their work. This allowed more companies to do work a lot faster and to try new ideas. For some of these ideas, the groundwork was already laid. Viral vector vaccines like AstraZeneca have been used for decades in Canada and around the world.
mRNA vaccines like Pfizer and Moderna are a newer technology, but that doesn’t mean they haven’t been tested or studied. Human trials of cancer vaccines using the same mRNA technology have been taking place since 2011. In fact, Moderna already had an influenza mRNA vaccine developed before this pandemic started. While the message in the vaccine changed, we already had the envelope to deliver it.
Even the trials were faster because it was so easy to recruit participants and because there was so much virus in the community – it didn’t take very long to find out if the vaccine could fight the circulating virus.
The science was not rushed, but all the administrative work around the science was fast-tracked. This is because the whole world was on board with one goal in mind, a COVID19 vaccine that is safe and will help us out of this pandemic.
Health Canada Approval
The approvals also happened faster than usual. Like all vaccines, Health Canada reviews the safety and effectiveness of all COVID-19 vaccines that will be used throughout the country. Canada is recognized around the world for its high standards for drug and vaccine review, approvals and monitoring systems.
These vaccines followed the same process as any other vaccine. All prescription medications and vaccines are required to complete three trial phases before approval.
Phase 1 uses a small number of participants to look at safety. It tests various doses of the product to see what side effects occur and how they affect participants.
Phase 2 trials are a bit larger and typically include a larger variety of participants. They look at the immune response to the vaccine to ensure that it works the way it should.
Finally, Phase 3 trials are larger, with thousands of participants. This trial starts to look at how well the vaccine actually prevents infection.
All three of these phases were done and completed just as they needed to be. Again, what changed here was the pace.
Normally Health Canada requires companies to submit all of their data from Phases 1, 2 and 3 at the same time for evaluation. But in this case, Health Canada reviewed each trial as it was completed.
Companies didn’t need to wait their turn to have their applications reviewed, Health Canada did them in real-time. This meant that less time was required at the end of Phase 3 in order to get approval because Phase 1 and 2 had already been reviewed.
The science behind these vaccines is solid. They are safe, effective, and built on technology that we know and understand.