Brock University researchers studying the COVID-19 virus are sounding the alarm that rushing the approval process for a vaccination could have “terrible” consequences.
Given the enormous pressure to develop a safe and effective COVID-19 vaccination, Adam MacNeil, professor and Brock immunologist, is concerned that speeding up the Phase 3 approval process for vaccine development may “have terrible and multifactorial consequences far beyond the underlying biology. ”
“The eyes of the whole world are on this attempt to create a successful COVID-19 vaccine. It is very important that we do it right. It is very important that we take all the appropriate measures to ensure that we do not erode all the trust that we have developed, ”he said.
Adding to the concern was a recent announcement that Russia has approved an early COVID-19 vaccine called Sputnik V for use in vulnerable population groups, including medical personnel and the elderly – although it does has only been tested in 76 patients.
The Sputnik V vaccine – one of 165 potential vaccines in development globally and six that have now entered Phase 3 clinical trials – won’t be widely used until after the start of the new year, as more clinical trials important continue. But with so little testing, MacNeil said he wouldn’t take Sputnik V if given the chance.
“No, I wouldn’t take that one,” he said.
MacNeil said researchers were more concerned with making sure people were comfortable with any other vaccine that might become available – and making sure a vaccine is properly tested could be a factor in that regard.
A phase 3 clinical trial typically has 10,000 to 30,000 study participants and can often take years.
“For a vaccine to be effective, you have to establish what is called collective immunity, and that requires a critical threshold of people to be truly willing to be vaccinated. That’s what matters, ”he says.
“You are certainly talking about thousands and tens of thousands of people to be able to say that a vaccine is safe and effective. “
In addition to undermining public confidence in vaccinations, there are other concerns related to accelerating vaccine development.
Brock’s student, Jeremia Coish, studied a rare complication known as antibody-dependent enhancement (EAD), in dengue hemorrhagic fever for his doctoral thesis.
While it has not yet been determined whether ADE could be a factor in COVID-19, MacNeil said he believed it was “a concern that the scientific community and the general public may need to know about. ‘hear”.
“Ideally, you want the best vaccine possible,” said Coish, who recently researched COVID-19 at the Level 3 lab at Brock.
Despite the rarity of potential complications such as ADE, the impact would be exacerbated if the vaccine were widely used.
Niagara’s acting medical officer of health, Dr Mustafa, said Hirji, said if Canada offered vaccination to its population of over 30 million people and there would be side effects even for one in 10,000 people , many people would be affected. .
Hirji is confident that the Canadian government will not cut corners when it comes to vaccine approval, adding that the process cannot be safely expedited.
He said the fastest vaccine development was four years for mumps, but more generally it was a decade-long process.
Even with the world working together to develop a COVID-19 vaccine, there is a certain period of study that cannot be shortened and it is unlikely that an effective vaccine will be available until next year.
The first vaccine is unlikely to be as effective as traditional vaccines, he said, because there won’t be an opportunity to determine which one is better.
“Maybe we’ll get lucky and it turns out to be a really good vaccine, but I think we need to be prepared that the first vaccines that come out maybe not the optimal vaccines and that it will take a little while before we get them. these vaccines, ”he said.
“That being said, even a vaccine that is 20-30% effective is huge. It takes us from zero percent immunity to 20 to 30 percent immunity, which is a big difference. ”
Hirji said the importance of security cannot be compromised.
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Coish and MacNeil cautioned against speeding up the vaccine approval process in an article in the scientific journal Microbes and Infection published in June.
MacNeil said the risks of rushing vaccine development are substantial.
“They go beyond the simple response to COVID-19. They speak directly about the contribution of immunization as a global public health platform.