Testing milestones, U.S. boasts and Canadian hope
Here’s what you need to know from this week’s COVID-19 vaccine news
Considered one of the few ways to finally bring the pandemic under control, the search for a COVID-19 vaccine is moving fast.
Teams around the world are at work on dozens of potential vaccines in the hopes that one of them — and possibly more — will crack the code in the coming months; passing clinical testing and gaining regulatory approval.
Thousands of people are already rolling up their sleeves for clinical testing, while debates are underway about issues such as who will get a vaccine first? How will it be distributed? How do we make sure parts of the world aren’t left out?
From the cost for everyday Canadians, to the death of a trial participant, to U.S. President Donald Trump’s claims that a vaccine is “ready,” here’s what you need to know this week.
Vaccines won’t come with a fee for Canadians
When Health Canada approves COVID-19 vaccines for use in this country, they’ll be provided to Canadians at no cost, a spokesperson for Health Canada confirmed this week.
Which is not to say they’re free, exactly, as the federal government has spent somewhere in the neighbourhood of a billion dollars so far locking down advance purchase agreements for leading vaccine candidates. The exact details have been kept under wraps, with the federal procurement minister citing the competitiveness of the market. Pharmaceutical companies have been similarly mum, but the few public estimates on cost available range from about $5 a dose, to upwards of $50.
The need to get a critical mass of people vaccinated — and, hopefully, stop the pandemic — has even persuaded some countries without public health care to provide shots free of charge.
Among them, the U.S., which announced a goal last month that no American will have to “pay a single dime” for a vaccine, the New York Times reported.
Ottawa invests
Federal officials have spent months securing access for Canadians to potential vaccines from around the world, but this week, they offered a show of confidence in a Canadian-made candidate.
Prime Minister Justin Trudeau on Friday announced a deal for 76 million doses of a plant-based vaccine in development in Quebec City.
A biotechnology company called Medicago is getting a total of $173 million for doses of its vaccine, which is wrapping up Phase 1 tests, and to help pay for a vaccine-and antibody-production facility.
Brazilian vaccine trial continues despite death
A volunteer who was enrolled in a clinical study of the vaccine candidate being developed by AstraZeneca and Oxford University has died, Brazil’s health authority said Wednesday.
But the trial will continue, and researchers from the British university reportedly say there are “no concerns about safety of the clinical trial.”
Reporters for international news agency Reuters said they talked to an unnamed person familiar with the situation who said the trial would have been suspended if the volunteer who died had received the vaccine, which suggests that they had not. Anytime a volunteer suffers a serious side effect, a clinical trial must stop.
Clinical trials test the efficacy of a new vaccine by giving the experimental dose to some people, then giving a different vaccine or a placebo to a different group. In the case of this trial, the control group was giving a meningitis vaccine instead. Reuters’ report suggests that the person who died was in the latter group.
Both Johnson & Johnson and AstraZeneca have previously paused at least some trials while problems experienced by volunteers were investigated to see whether they had been caused by vaccines, but both said this week they were resuming.
According to CNN, the FDA gave AstraZeneca the nod to resume its U.S. trials, while Johnson & Johnson said it had identified “no clear cause” of its volunteer’s illness, so it was starting back up.
Trump claim that a vaccine is ‘ready’ is ‘dangerous’
During the final debate between Trump and Democratic rival Joe Biden on Thursday, the sitting president began by saying that “We have a vaccine that’s coming; it’s ready. It’s going to be announced within weeks, and it’s going to be delivered.”
When pressed, he said that was “not a guarantee” but that there is a “good chance” of one being ready in weeks.
Trump’s statement isn’t accurate and risks undermining public confidence in an eventual vaccine, says Dr. Alan Bernstein, the president and CEO of CIFAR, a Canadian-based global research organization, and a member of Canada’s COVID-19 Vaccine Task Force.
“For President Trump to say that it’s ready implies that there’s one step when there are multiple, multiple steps even once the trial is finished before we will have a vaccine,” he said.
Meaning, while some vaccines could see clinical testing results in a matter of weeks, that information would still have to go to the regulator for final approval. In the U.S., that means the Food and Drug Administration, and here it’s Health Canada.
An eventual vaccine will also have to be manufactured and distributed.
Making claims such as Trump’s raises expectations, Bernstein says, but also undermines public confidence in the safety of a vaccine. “It politicizes the process. And I think that’s very dangerous, because then people will wonder, ‘Is this really all about politics? Or is that vaccine really safe?’ ”
The regulatory processes in the U.S. and Canada are totally separate, meaning any vaccine deployed in Canada will have to be first approved by scientists at Health Canada.
Human-challenge testing to go ahead in the U.K.
British scientists confirmed this week they are going ahead with the world’s first human-challenge tests for COVID-19, which means they are deliberately infecting healthy volunteers with the virus.
The hope is that this will help scientists understand the virus better, and eventually allow them to test treatments and vaccines more effectively, and ultimately bring the pandemic to heel sooner.
While human-challenge testing is used to develop other types of drugs — malaria medications, for example — it remains a controversial approach to COVID-19 because of a lack of what are known as “rescue” drugs. In other words, if a volunteer develops severe complications of COVID-19, doctors don’t have a surefire way of treating them.
According to a release from Imperial College London, a research institution that is getting funding from the British government, they’ll start by recruiting volunteers between ages 18 and 30 with no previous history of COVID-19, and no known risk factors.
Inside a quarantined lab, researchers will try to figure out just how much virus someone needs to be exposed to before they get infected.
The hope is that researchers will eventually be able to start testing vaccines. Deliberately infecting volunteers will allow them to figure out which ones work a whole lot faster.
The study is set to begin early next year.
Moderna reaches goal
Moderna, a Massachusettsbased biopharma company, the first to start testing its vaccine in the United States, hit its enrolment target this week — meaning it now has 30,000 volunteers ready to roll up their sleeves for their two-dose shot.
This is noteworthy for a couple of reasons, the major one being that the company, whose mRNA vaccine has long begun considered a front-runner, is entering the home stretch in the vaccine-testing race.
But it’s also notable since they’d faced challenges early on in recruiting a diverse pool of volunteers. Any vaccine that will eventually be rolled out around the world needs to be tested on as wide a range of people as possible, to make sure it works for everyone. That’s presented challenges for some companies.
Moderna began Phase 3 testing on July 27, and a month later had about half the number of people they needed, but reported that only about a fifth of its participants were Black or Hispanic, despite those communities being disproptionate-ly affected by the pandemic.
The company actually slowed recruitment to focus on recruiting a more diverse group.
On Thursday, as it announced the completion of enrolment, it touted the diversity of its final volunteers.
In the end, 37 per cent of participants were from communities of colour, Moderna said, including 6,000 people who identified as Hispanic or LatinX, and 3,000 who identify as Black or African American.
“We are indebted to all of the participants in the study. We would also like to thank the investigators and our partners at clinical trial sites,” CEO Stéphane Bancel said.
The need to get a critical mass of people vaccinated has even persuaded some countries without public health care to provide shots free of charge