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opinion: why do vaccines take so long?

while it may seem crazy that we have to wait 12-18 months for a vaccines, the delay is in the name of safety.

opinion: why do vaccines take so long?
close up of examining of test sample under the microscope in laboratory.
around the world, the research community is working together to develop vaccines to fight covid-19.

here in ontario, a multidisciplinary team of western university researchers in london are working on the development of a covid-19 vaccine based on constructs developed for an hiv vaccine. the work is being done in western’s imaging pathogens for knowledge translation (impakt) facility which contains canada’s newest containment level 3 facility and state-of-the-art imaging equipment that will allow the researchers to safely study the virus in detail.

despite worldwide efforts, we likely cannot expect a vaccine that’s ready for use for another 12 to 18 months. during this time of crisis, some may wonder why it takes so long. can’t we skip the normal processes and start delivering the vaccine to people right away?
the short answer is no. trials are needed to ensure the safety and efficacy of the vaccine.
what does a vaccine trial look like?

in seattle, washington, a new clinical trial for a potential coronavirus vaccine recently began at kaiser permenente washington health research institute. the vaccine was developed quickly by massachusetts-based moderna inc, and is the first to be tested in humans.

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the moderna phase 1 trial is looking at the safety of the vaccine, not the efficacy. the safety of the vaccine must be tested first to ensure the vaccine does not cause any harm before widespread use. while vaccines have an excellent safety profile, experimental vaccines have failed phase 1 studies in the past due to a wide range of unforeseen serious adverse events including cytokine storms, fever, seizures, even enhanced susceptibility to the very infection it is trying to prevent.
this trial is part of the normal 3-phase clinical development. after the phase 1 trial is complete, the work of studying the efficacy of the vaccine begins.
the study of this vaccine will only be performed in healthy volunteers, not patients infected with covid-19. most of the vaccines being developed for covid-19 are prophylactic, meaning they are intended to build up immunity and prevent someone from getting sick. this presents a unique challenge in assessing the efficacy of the vaccine, and adds to a study’s timeline compared to a therapeutic trial.

a vaccine trial is very different from a therapeutic trial. in a therapeutic trial, patients are administered a drug and monitored for improvement of the illness. but in a vaccine trial, a researchers needs to prove that a person would have gotten sick if the vaccine wasn’t administered. that’s a more difficult fact to prove. of course, infecting a healthy person with the virus to test the vaccine is out of the question, so the alternative is to give the vaccine to a large number of people (hundreds or thousands) and track to see if infection rates differ compared to a placebo population over a period of time. in the case of covid-19, if the trial is successful, it will likely be approved quickly because there is an urgent unmet need and no other competing vaccine. however, it can take time to ramp up production of the vaccine to deliver the millions of doses needed to protect people globally.

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what kind of vaccine trials are underway?
beyond the work being done at western university in ontario and by moderna in the u.s., many others here in canada and across the globe are moving quickly to develop covid-19 vaccines.

a team of researchers from sunnybrook, mcmaster university and the university of toronto recently isolated the covid-19 virus which will help researchers develop better diagnostic testing, treatments and vaccines.

winnipeg’s emergent biosolutions is working on an oral vaccine that would be both a therapeutic and prophylactic by giving the patients a dose of anti-covid antibodies. the company is partnering with two companies in the u.s. to accelerate development. clinical trials are expected to begin in the late summer.

entos pharmacueticals, an edmonton-based company, is developing a dna-based vaccine for covid-19. the company is planning to have a vaccine ready for trials within a few weeks.

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a company from china, cansino biologic, is about to start their first trial. cansino biologic’s approach involves taking a piece of coronavirus’ genetic information and encoding it in a harmless virus. in this approach, they are exposing healthy volunteers to that harmless virus in the hope of generating immunity. they have received regulatory approval and will start the trial soon.

how will we know when we’re through this?
the global research and medical communities are working with every effort to slow spread, contain the virus and find a solution. there are a few tell-tale signs that can help us gauge when we have the upper hand over the covid-19 outbreak.
first, when we know the distribution of the virus. do the patients who are sick represent the full scope of the outbreak, or just the tip of the iceberg? answering this question will require more testing. many organizations, including non-medical private companies, are joining the fight to get more test kits into the hands of medical professionals.

second, when we have a treatment that works. this is the top priority for the research and clinical trials community, with governments around the world supporting the effort. in canada, the federal government recently announced $275 million to support researchers and companies working to find solutions, including potential vaccines and treatments.

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third, when we have ‘herd immunity’. it is suggested that once people contract covid-19 and are no longer infectious, they will become immune to the virus. together with a successful vaccination in place, this will help populations achieve herd immunity — when a significant proportion of the population is immune to the virus. with herd immunity, we will begin to see more people able to care for others and return to daily life.
as we wait for these milestones, it is vital that we flatten the curve of spread and reduce the strain on healthcare systems through self-isolation, hand-washing and other measures advised by authorities including the public health agency of canada and the world health organization. these are the steps that all of us can take to help save lives and keep our neighbours safe.
 

clinical trials ontario  is a non-profit organization dedicated to strengthening the environment for conducting high-quality clinical trials, working collaboratively with research institutes, patients and the public, industry and other health innovation organizations.

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lisa machado
lisa machado

lisa machado began her journalism career as a financial reporter with investor's digest and then rogers media. after a few years editing and writing for a financial magazine, she tried her hand at custom publishing and then left to launch a canadian women's magazine with a colleague. after being diagnosed with a rare blood cancer, lisa founded the canadian cml network and shifted her focus to healthcare advocacy and education.

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