While the vaccine has arrived, some experts still have concerns.
The lack of scientific peer review raises some concerns, says Byram Bridle, a viral immunologist at the University of Guelph currently doing research to help prepare a vaccine for the next highly pathogenic coronavirus.
“As an immunologist, I like to point out that I really promote the value of vaccines. I teach immunology and I teach all of my students that good quality vaccines that have been vetted by the scientific community are, in my opinion, the best tool that we have in our medical toolbox and the most efficient ways to save a huge number of lives and a great form of preventative medicine,” said Bridle.
The problem, he says, is we just don’t know the long-term effects of this vaccine regardless of the new technology used.
“These vaccines have only been in people at most for half a year. And that's probably a bit liberal,” says Bridle.
“That means that we can really only have absolute confidence in the safety of the vaccine up to about six months.”
He says even when a vaccine takes years to develop, safety is still monitored when it goes out to the general public. But in this case, companies will be monitoring the results for at least the next two years once everyone gets vaccinated in order to collect safety data.
“This has never happened before. To collect that long term data. To know whether it continues to be safe a year after vaccination, two years after vaccination. We always had that data previously. We don’t have it now and we will only get it as we monitor the rollout,” says Bridle.
Bridle says many companies were developing a vaccine for MERS and were able to quickly switch over when COVID-19 came along.
Although these were made at a record-shattering pace, it's not quite the same as historical vaccines that had to start from scratch, says Bridle giving the example of the Ebola vaccine, which had several years of accumulated safety data before it was distributed to the public.
He says although the vaccines have met the milestones required for them to be approved by governing healthcare bodies, they are being rolled out without the phase 3 clinical trials being 100 per cent completed.
“I’m not judging the vaccines in any way, shape, or form. I’m just trying to state the facts,” says Bridle.
“I have been asked many times personally would I take the vaccine right now? Personally, I don’t feel 100 percent comfortable with it,” says Bridle, adding that historically there have been side effects from vaccines despite taking some time to manifest.
“If there are any chronic issues with this, we’re not going to be aware.”
He says for him personally, two things need to take place to ensure the safety of the vaccine: first, it needs to be approved by Health Canada, and second, the results from the phase 3 clinical trials need to be available – which really tells how the vaccine is working and what the safety profile looks like.
“I want to see that (phase 3 clinical trials) published and to go through rigorous scientific peer review.”
On Dec. 9 Health Canada approved the Pfizer vaccine and stated that along with the Public Health Agency of Canada, it will closely monitor the safety vaccine once it hits the market, and also take necessary steps if there are safety concerns.
It also published documents about the vaccine ingredients, allergies, and possible side effects.
Regardless, Bridle gives the analogy of two toys priced the same but from different companies sitting on a shelf. One has a high-quality control system in place while the other has little to no quality control.
“When it comes to science, our quality control is the peer review process,” says Bridle.
He says to publish the data, first of all, it has to go through the hands of reviewers to ensure the science is good and when it gets published, the entire scientific community has access to that data including scientists around the world who have no connection to that research and who have nothing to gain from that vaccine being marketed.
“Right now the phase 3 clinical trials have only been seen by the regulatory agencies. I trust they’re doing their job. I also imagine that they’re probably under the most enormous pressures that they’ve ever been in their careers in terms of trying to get a vaccine developed as soon as possible,” says Bridle.
Nevertheless, he says decisions are being made by a relatively limited number of scientists.
“Yes, they have lots of expertise in the area but again, that’s what I want to see personally and that's how it's happened in the past,” says Bridle.
Bridle also talks about potential rare side effects which are normally not a big concern, however, because the goal is to roll the vaccine out on a global scale, Bridle says even very rare side effects could end up affecting a large number of people.
He gives the example of the two individuals who suffered an anaphylactic reaction in the UK the very first day the Pfizer vaccine rolled out.
“That’s only two people out of however many that were vaccinated that day,” says Bridle adding that once the vaccine is administered across the globe, it's possible hundreds of thousands of people have an anaphylactic reaction or something else.
After those allergic reactions, those with allergies were immediately told not to receive the vaccine.
“And then you can start asking the question, how many people with these allergies were enrolled in these trials? Well, because the data is not published, we don’t know this,” says Bridle adding that the vaccine is to only be administered in centers that have the equipment and expertise available to resuscitate people.
“The fact of the matter is, not everybody with a pre-existing condition could be tested in the phase 3 trials. Scientists have not been able to evaluate it and we’ve just simply had a very limited number of months in which this vaccine could be assessed and that only by those looking at the clinical trials.”
“I personally cannot assure anybody 100 per cent that there are going to be no issues.”