At least 70 research teams, including some in Canada, are racing to develop potential pandemic vaccines within a year — an accelerated pace in an unprecedented search for an end to humanity’s lockdowns.
So far, the number of vaccine developers that have shifted from lab studies in animals to early-stage clinical trials in human volunteers can be counted on one hand. But scientists are hopeful they can speed up the research and bypass some of the usual red tape that slows down the vaccine approval process.
In a pandemic, no one has immunity to the virus because it is new. The goal of a vaccine is to expose our immune system to part of the virus so our antibody fighters can prepare to attack the virus that causes COVID-19.
Dr. Scott Halperin, of the Canadian Immunization Research Network, said it’s important to have multiple versions of the vaccine that achieve the same purpose but work in different ways.
“Hopefully there’ll be five, six, seven, eight successful vaccines, because we have a whole globe that we need to protect,” the Halifax-based physician and researcher said.
The first phase of clinical trials focuses on safety, with about 30 to 50 volunteers testing out different doses of shots.
A critical next step is Phase 2 trials in a larger number of people to look for signs that the jabs meet the goal of protecting against infection.
China’s CanSino Biologics is beginning the second phase of testing a vaccine candidate, adapted from the company’s Ebola research, according to China’s Ministry of Science and Technology. Another vaccine candidate is in Phase 1.
In the U.S., Pennsylvania-based Inovio Pharmaceuticals began a Phase 1 trial last week of its vaccine candidate that uses the DNA sequence extracted from the key spike protein of SARS-CoV-2, the virus that causes COVID-19.
The idea is to train the person’s immune system to seek out the telltale crown, or corona of spikes that gives the coronavirus its name.
“It’s like an FBI poster,” said Inovio’s president and CEO, Andrew Kim. “Anytime you see any signature, something that looks like this spike, go pounce on that with the full force of your immune system.”
The big ‘if’
Earlier this week, the first person received a second dose of another potential U.S. vaccine from the National Institutes of Health (NIH) and Massachusetts-based biotech company Moderna Inc.
NIH infectious disease chief Dr. Anthony Fauci told The Associated Press there are “no red flags” so far and he hoped the next, larger phase of testing could begin around June.
If SARS-CoV-2 continues to circulate widely into fall, it might be possible to complete larger trials in human volunteers sooner than the 12 to 18 months he originally predicted.
“Please let me say this caveat: That is assuming that it’s effective. See, that’s the big ‘if,” Fauci said. “It’s got to be effective and it’s got to be safe.”
Normally, it takes from seven to 10 years to go from the lab to the arms of patients, Halperin said.
“What’s mainly being accelerated are the various administrative steps, not the safety steps,” he said.
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Halperin said Canadian researchers hope to have some potential vaccines in clinical trials within the next four to six weeks.
Jonathan Kimmelman, a biomedical ethics professor at McGill University in Montreal, is watching how both scientific and ethical standards are maintained while the pandemic vaccine trials progress at breakneck speed.
“My concern is that, in the fear and in the haste to develop a vaccine, we may be tempted to tolerate less than optimal science,” Kimmelman said. “That to me seems unacceptable. The stakes are just as high right now in a pandemic as they are in non-pandemic settings.”
To show how long the process can take, Kimmelman points to the example of the ongoing search for an effective HIV vaccine than began in the 1990s
Before healthy people worldwide receive a vaccine against SARS-CoV-2, the risk/benefit balance needs to tip in favour of the vaccine’s efficacy in offering protection over the potential risks, he said. The balance still exists even in the face of a virus wreaking an incalculable toll on human health and society.
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