This is an excerpt from Second Opinion, a weekly roundup of health and medical science news emailed to subscribers every Saturday morning. If you haven’t subscribed yet, you can do that by clicking here.
When Evan Fein enrolled in a COVID-19 vaccine clinical trial earlier this year, he understandably had some questions about the vaccine’s safety.
The 32-year-old data analyst from Brooklyn wanted to help in the search for a safe and effective vaccine by joining the Pfizer-BioNTech clinical trials in New York City. But he was also concerned that not enough research had been done on the vaccine at the time.
“It was one of those things where it was always in the back of my mind,” he told CBC News. “If you Google enough things, you’ll always find somebody who’s concerned about something.”
Fein spoke publicly about his experience this week before an expert advisory panel to the U.S. Food and Drug Administration, a day before the FDA granted emegency use authorization for the Pfizer-BioNTech vaccine in the U.S..
Experts say that since the COVID-19 vaccine, which will begin rolling out in Canada next week, may face an uphill battle gaining the confidence of Canadians, it will be important for those participating in trials or selected to be in the first cohort to get the vaccine to share their stories.
Not sure if he received vaccine or placebo
Fein says the greatest reassurance for him when deciding whether or not to participate in the trial came from the researchers themselves, who provided him with clear, helpful information throughout the process.
“They told me what to expect,” he said. “They said, ‘You might feel this. You might get a fever. You might get muscle pain.'”
He doesn’t know for sure if he was getting the vaccine or a placebo when he received two doses in July. But Fein said he suspects he received the actual vaccine because he experienced pain at the injection site, chills and a mild fever.
“It bothered me, but it all went away within 48 hours,” he said. “If you look at it in columns of risk versus reward, it’s almost all reward. The tradeoffs are absolutely worth it.”
Six months later, Fein says he has had no long-term symptoms. “None,” he said. “Nothing after 48 hours.”
He has, however, received a fair bit of attention for participating in the trial.
“A lot of people have told me, ‘You did a great job. This is an amazing thing you did.’ And it’s nice to be flattered like that, but in reality, this wasn’t that big of a deal,” Fein said.
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While Fein understands there are people who are hesitant about getting a new vaccine or don’t want to get one at all, he doesn’t think there is a “magical message” that will change their minds.
“I don’t believe in forcing anyone to take it,” he said. “I don’t think mandates or belittling people for not taking it is very effective.
“I think more important than a message is that they see leaders, they see people in their communities, they see family members and friends actually taking the vaccine.”
Canada may have ‘hard time’ addressing hesitancy
As Canada navigates a worsening second wave of the pandemic, the effective rollout of COVID-19 vaccines is considered essential to controlling the spread of the virus and bringing some semblance of normal back to everyday life.
“It’s really exciting to think that we’re able to address this pandemic so quickly with a vaccine,” said Alyson Kelvin, an assistant professor at Dalhousie University in Halifax and a virologist at the Canadian Center for Vaccinology evaluating Canadian vaccines with the VIDO-InterVac lab in Saskatoon.
“I’m hopeful that if we get these initial doses into people who are either more vulnerable to severe disease, or the people who are caring for them, then we could see somewhat of an immediate impact on the amount of deaths and ICU admissions.”
But for those who are hesitant about taking a vaccine because of lingering questions about safety, efficacy and necessity — experts say transparency, openness and compassion are key to addressing concerns.
“What actually worries me the most about this vaccine rollout is how well we’ll do about getting information to Canadians so they’re confident in the vaccine,” said Dr. Allison McGeer, a medical microbiologist and infectious disease specialist at Toronto’s Mount Sinai hospital.
“This is a new vaccine, it’s different than vaccines we’ve tried before, people are going to be worried about it and we need to get a lot of information to a lot of people in a really short period of time to make this vaccination program work.”
While the approval process for the Pfizer-BioNTech vaccine was done in just a couple of months, Health Canada’s chief medical adviser, Dr. Supriya Sharma, told CBC News it was no less comprehensive in evaluating the vaccine’s safety.
“We’re holding the vaccine to the same standards but what we’ve done is that we’ve put more resources on it, we’re doing things in parallel rather than doing one thing after another,” she said.
“So, even though the overall timeline has been shorter, the review itself has actually been just as rigorous as what we normally do for a vaccine.”
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McGeer says addressing people’s anxieties around COVID-19 vaccines could be a real challenge — especially given the stage of the pandemic we’re in.
“We’ve all kind of gotten a little bit used to COVID — it’s not as scary as it used to be, it doesn’t seem as dangerous in some ways,” she told CBC’s The National this week.
“That may mean that we have a hard time getting information to people so that they get their vaccine.”
Dr. Noni MacDonald, a professor of pediatrics at Dalhousie University and a global expert on vaccine hesitancy, says one of the best ways to assuage concerns over the vaccine is by normalizing it in society.
“Seeing and knowing people who’ve been immunized will help,” she told CBC News.
“So people who get immunized need to talk to the people they know in their social networks about how important it is to get immunization and that it wasn’t such a big deal.”
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MacDonald says Canada’s first delivery of 249,000 doses of the recently approved Pfizer-BioNTech vaccine will help to normalize immunization, but it will be months before the general public will have the opportunity to even get a COVID-19 vaccine in Canada
“By the time it comes around to the more average person being able to get immunized … there will be a lot more information out there,” she said.
“People will know much more about how safe it is and people I think will be much more reassured that this is the right thing to do.”
Adverse events raise concern, but more data needed
Concerns have also been raised by news outlets this week that two healthcare workers in the United Kingdom with a history of serious allergies had adverse events after being given the vaccine.
While it’s not clear yet if the reactions were due to the shot specifically, health officials are investigating and have warned that those who are prone to severe allergic reactions should not take the Pfizer-BioNTech vaccine for now.
“Right now, we don’t exactly know what happened, but I think it’s important to err on the side of caution,” said Dr. Sumon Chakrabarti, an infectious disease specialist at Trillium Health Partners in Mississauga, Ont.
“We do know that reactions can happen with vaccines and occasionally it can be severe. It’s important to be transparent about these events and vet closely to understand what happened.”
Prime Minister Justin Trudeau announced Thursday, ahead of the vaccine rollout next week, that Canadians who experience an adverse event after immunization will be eligible for compensation as part of a new national no-fault program.
“Canadians can have confidence in the rigour of the vaccine approvals system, however, in the rare event that a person experiences an adverse reaction, this program will help ensure they get the support they need,” Health Minister Patty Hajdu said in a statement.
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Dr. Zain Chagla, an infectious diseases physician at St. Joseph’s Healthcare Hamilton and an associate professor at McMaster University, said narrowing down what caused the reaction will help people understand more about its safety.
“There is probably a component in the vaccine that’s triggering the response if this is a true issue,” said, adding there will still be options for those with severe allergies.
“Theoretically if the Moderna vaccine comes around and doesn’t have that component, that may be an option. If they have a shared component, then perhaps one of the novel vaccinations down the road.”
While it’s unusual to see vaccine safety data being released in real time, Chagla said those who are hesitant about getting a COVID-19 vaccine will have more data to draw from as time goes on.
“We do know that other adverse events will happen and we need to then figure out if they’re actually due to the vaccine or something else that’s been going on at the same time,” said MacDonald.
“We need to talk about things like that when they happen, we need to explain what happened and we need to address people’s concerns about it.”
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