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covid-19: why is the race to a vaccine taking so long?

  when a vaccine makes it to human clinical trials, it ...

covid-19 has brought to the forefront the importance of vaccine development. stock/getty

as covid-19 cases continue, researchers around the world are racing to understand the virus, develop treatments to help those who are infected and produce a vaccine to protect others. as of march 2020, there were 20 vaccines in development for covid-19 .

 

the process

when a vaccine makes it to human clinical trials, it first goes through phase one trials to test safety and effectiveness in a small number of people — usually about 20 to 50 participants. phase two trials are larger, with tens to over a hundred participants. phase three trials involve thousands or tens of thousands of people to determine how well the vaccine is working and what side effects exist. many vaccines undergo a phase four trial, and are studied on an ongoing basis after the vaccine is approved and licensed.

experts are saying developing a vaccine will take 12 to 18 months. why does it take so long?

generally,  vaccine development requires a multi-stage approach. it begins with a clinical research phase, which can include animal and some human testing, as well as four phases of testing, which can range from several months for phase one to several months to years for each subsequent phase. a typical vaccine development process lasts ten to 15 years, according to the history of vaccines, and an average of 7.6 years to go from phase one to launch. health authorities, as well as some vaccine researchers, have said that the vaccine for the coronavirus could be available in 12 to 15 months

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how close are we?

at the time of writing, a vaccine manufactured by beijing institute of biotechnology and cansino biologics is in phase two of a clinical trial — a non-randomized dose-escalating study. the trial is set to be completed in december 30, 2020. the estimated study completion date is december 20, 2022.
other companies that are in phase one of a vaccine clinical trial include boston-based biotech firm, moderna therapeutics, which working on a vaccine alongside the national institute of allergy and infectious diseases (niaid) vaccine research center (vrc). oxford university researchers are also set to start human trials for their vaccine, having tested it in animals. the vaccine is based on an earlier vaccine design which was used in potential vaccines for malaria, tuberculosis and middle east respiratory syndrome (mers) vaccines.

what’s happening in canada?

in canada, medicago has produced the virus-like particle in covid-19, an essential first step in creating a vaccine. the company works with plant-based treatments to target virus contamination and limit its mutation. human trials are expected in july or august. the firm aims to have a development program submitted to health authorities by november 2021.

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the vaccine and infectious disease organization-international vaccine centre at the university of saskatchewan recently received $23 million in federal funding and reports it is close to developing a working version of the vaccine that will undergo early human trials. western university’s imaging pathogens for knowledge translation facility, or impakt, is also working on a covid-19 vaccine. and  entos pharmaceuticals , a biotech firm based in alberta, is aiming to develop a dna vaccine in the coming weeks so it can begin trials.

what obstacles exist in developing a vaccine?

“it is worth noting that our track record with vaccine development in other coronaviruses isn’t great,” says dr. charles weijer , a bioethicist and professor of philosophy and medicine at western university and an advisor to the who expert group on human challenge studies and covid-19. “we have no vaccine for sars or mers and, of course, we have no vaccine for the common cold.”

one reality scientists will have to face is the mutation of the virus. “whenever you’re dealing with a new virus, you don’t know how it’s going to mutate,” says dr. ian culbert, executive director of the canadian public health association. researchers recently released a study of records from the u.s., china, spain, brazil, australia, finland, india, italy, nepal, south korea, and sweden. they found that one sample collected in india on january 27, 2020 showed the “first evidence” of a “significant” mutation of sars-cov-2.

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another obstacle will be finding healthy volunteers who have not had the virus, says culbert. due to the contagiousness of the virus, the pool of trial candidates will decrease over time. “you have to have a sufficient number of people who have not been exposed to the virus,” he says.
how much vaccine will we need?

finding a vaccine is one thing — but ramping up production is another. “mass production takes time,” says culbert. and building manufacturing capacity requires hundreds of millions of dollars, according to recent research n the new england journal of medicine .

to get an idea of how many doses of a covid-19 vaccine will be needed, consider that there are traditionally 600 to 800 million doses of seasonal influenza vaccine produced for the northern hemisphere annually. the covid-19 pandemic will likely require many more doses, as each inactivated vaccine requires multiple doses to build immunity. researchers say that the growth of the epidemic can be substantially reduced or even stopped by vaccination of less than the entire population — with a vaccination rate of 89 per cent rather than 100 per cent.
how are vaccines manufactured?

manufacturers  of vaccines are often headquartered in developing countries and must meet the standards of different regulatory agencies using different release criteria and requiring different testing methods for release in their specific jurisdiction. however, complexities in manufacturing lead to occasional disruption of supply caused by batch or production failures, quality control issues with bulk or finished products, a breakdown of the cold-chain in delivery, and a failure to predict variations in demand, according to a 2011 study in the lancet.

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vaccines can be licensed directly in those countries that have highly developed regulatory authorities, while other countries rely on licensing in the country of manufacture, followed by review and approval by the final country of use. currently, most manufacturers release their initial batches within days of each other, yet the different logistics and capacities mean that their overall contributions to global supply are very different. other countries of the world may be supplied following direct order from public health departments and sometimes private customers on a case by case basis, or via international ngos. public markets are usually served by tenders, where international manufacturers compete with each other and with local suppliers on price, volume, and importantly, reliability of supply.  with current technology, vaccine supply is likely to be limited and delayed relative to the spread of an influenza pandemic.
is it time for human challenge studies?

human challenge studies are trials in which participants are injected with an infectious disease organism. these trials have the ability to speed up testing and the rollout of a covid-19 vaccine by many months, according to new research . but they aren’t risk-free. “this is controversial because there is a risk of death and there is no proven drug treatment for the disease,” says weijer. he says researchers are now weighing whether to do these tests on young people who are otherwise healthy, and therefore at low risk of complications or deaths.

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who will get the vaccine first?

in canada, immunization programming is a shared responsibility between federal, provincial and territorial governments, with provincial and territorial governments and local public health authorities undertaking the planning and delivery of immunization programming. the national advisory committee on immunization , naci, has been developing recommendations for the use of vaccines for canadians since the 1960s. naci works in parallel with the committee to advise on tropical medicine and travel (catmat) which guides the public health agency of canada on travel-related health hazards including vaccine preventable diseases. phac regularly publishes advice from naci and catmat as statements about new vaccines and, as new evidence and indications emerge, updates recommendations for the use of vaccines that are available in canada. https://www.canada.ca/en/public-health/services/canadian-immunization-guide/introduction.html

  once a vaccine is ready, high-risk groups will be prioritized. “we have a roadmap which was developed during the h1n1 pandemic,” says culbert. because vaccine supplies will likely be low when the vaccine is first rolled out, healthcare authorities will use a risk algorithm that will prioritize those people who are at highest risk of covid-19.

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these will include people with underlying health conditions, those who are at highest risk of infecting a large number of people, healthcare workers, essential services employees, police, and, importantly, people in remote communities with limited access to healthcare, such as first nations communities.
“when a vaccine was developed for the 2009 swine flu pandemic, rich countries outbid poorer countries and received an unfair share of the vaccine,” says weijer. “this can’t be allowed to happen again. we need a fair system of vaccine allocation that ensures access for the global poor.”
although canada, as well as many other countries are still in crisis mode, culbert says there needs to be a lot of attention paid to the development of vaccines and future vaccine rollouts.
“governments need to be thinking about what comes next.”
 
this story idea initially came from a reader who took part in our covid-19 ‘ask us anything’ initiative. want to know more? ask us a question here.

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