Quality concerns over Canada’s batch of Johnson & Johnson COVID-19 vaccines have prompted the nation’s health agency to withhold the shot’s rollout just days before deployment to the nation’s hardest-hit area.
On Friday, Health Canada announced it is holding back the J&J vaccine, a one-shot dose that experts and health officials touted as crucial in stemming the spread of the virus amid a devastating third wave of the pandemic, after it was revealed that parts of the batch were made in the same Baltimore plant where millions of other doses meant for the U.S. market had spoiled.
In a statement, the agency said that a “drug substance” that would undergo further processing to become the final J&J shot was made at the Emergency Biosolutions plant in Baltimore, and was later shipped to a separate location to be completed and then sent to Canada.
The plant was previously cited by the U.S. Food and Drug Administration (FDA) for several violations, including cleaning and sterilization as well as the potential for cross-contamination. That agency has since ordered the plant to stop making more J&J vaccines until it addresses the violations and manufacturing errors, which resulted in 15 million of those doses being destroyed.
Canadians wait eagerly for the 300,000 doses expected to roll out on Monday to hotspots across the country, with the leaders of some hotspots expressing disappointment over the vaccines’ delay as cases in some provinces continue to hit record highs.
Here’s what you need to know about the J&J COVID-19 vaccine.
Will the review affect vaccine hesitancy?
Health Canada in its statement did not give a timeline on when the review of the vaccine batch would be completed.
The agency, which is working with Janssen and the FDA on reviewing the batch, said the vaccines would only be released once it was “satisfied” that they met the department’s health standards.
University of Toronto Bioethicist Kerry Bowman also said that he and everyone else wouldn’t really be able to give a timeline on when that review would be completed.
According to him, news of Health Canada’s pullback of the vaccine could also have another added consequence — vaccine hesitancy.
Recent reports of rare adverse events, including that of bloodclotting, have arisen after patients took the AstraZeneca or J&J shot. Both Bowman and several other public health officials and experts have said that the reports have fueled vaccine hesitancy across the country, even after repeatedly voicing that such events still remain extremely rare.
Bowman however said there were actually two ways someone could view the implications of Health Canada’s stop to the vaccine.
A person could either look at it as another potential problem with taking a vaccine — or see it in a way that Health Canada’s system to safeguard and check the vaccines actually works.
Bowman said that people would either likely interpret it as either more “trouble” on the vaccine front, or the fact that Health Canada’s system was protecting us.
“But I think it will contribute to vaccine hesitancy because statistically, we know that there are many people that are vaccine hesitant. … But you know, I think for a lot of people, including me to some extent, it shows the system has some checks and balances and safeguards, and that’s a very good thing.”
How effective is the vaccine
Results from Johnson & Johnson’s Phase 3 trials in late January suggested that its vaccine reduced severe outcomes from contracting COVID-19 by 85 per cent and even prevented 100 per cent of virus-related hospitalization or death.
In March, following the vaccine’s approval by Health Canada, the agency’s chief medical advisor Supriya Sharma said that nearly 20 per cent of the participants in the clinical trials were 65 or older, and that there were also no differences in safety or efficacy compared to younger groups.
The shot was 72 per cent effective in preventing COVID-19 infections after four weeks in J&J’s U.S. trials, though that efficacy lowered to a 66 per cent average from other global trials — including a South African review that included a more transmissible variant.
In comparison, Pfizer and Moderna had results of 95 per cent efficacy in their respective trials but had been tested against the virus’ previous iteration and not against the increasingly prevalent and more infectious strains circulating today.
Health experts have since warned against comparing or “shopping” for vaccines, maintaining their stance that the best vaccine was the first one that was going into your arm.
Though not necessarily a factor in how effective the J&J shot is in preventing severe outcomes, the vaccine tenders a huge edge over others in it being able to be transported much easier — needing only to be kept in a refrigerator between 2 C and 8 C for at least three months.
Pfizer, on the other hand, needs to be stored at -70 C and Moderna between -25 C and -15 C. AstraZeneca’s storage temperature is also the same as J&J’s, at between 2 C and 8 C.
The makeup of the J&J vaccine was also different than the mRNA used in Pfizer and Moderna.
Using a non-replicating viral vector, similar to that of AstraZeneca’s, the shot uses a harmless virus that can’t copy itself — instead using it as a vector to tell our cells what they need to do to make COVID-19’s spike protein.
The immune system then recognizes the protein and then makes antibodies, then allowing someone’s body to fend off an attack if exposed to the virus again.
Adverse reactions and bloodclotting?
A new report published by the U.S. Centers for Disease Control and Prevention (CDC) has since found that only three per cent of the 13,725 incidents reported through the health agency’s Vaccine Adverse Events Reporting System after receiving the J&J vaccine were classified as serious.
According to the CDC, by April 21, a total of 17 blood clot incidents in patients who also experienced low blood platelet levels were found out of the almost eight million inoculations.
Fourteen of those blood clot reactions were found in the brain’s venous sinuses, and three were found elsewhere in the body among women who were aged younger than 60.
The review, released Friday, said that the overall “safety profile” of the vaccine was similar to what was seen in its clinical trials.
“A rare but serious adverse event occurring primarily in women, blood clots in large vessels accompanied by a low platelet count, was rapidly detected by the U.S. vaccine safety monitoring system,” researchers wrote in the report.
“Monitoring for common and rare adverse events after receipt of all COVID-19 vaccines, including the Janssen COVID-19 vaccine, is continuing.”
The agency’s report also included 88 deaths reported after taking the vaccine, of which three had occurred in patients with “cerebral venous sinus thrombosis,” but noted that none of the other deaths appeared “to have an association with vaccination.”
On Monday, Health Canada updated the J&J COVID-19 vaccine product label to include a “very rare” risk of bloodclotting.
“So far, we’ve got three out of four vaccines that have had issues … but I personally would not be surprised if it’s just a matter of time until all of them have issues, because once you roll these things out over millions of people — I think that’s going to happen,” Bowman said.
How would Canada best use the J&J vaccine?
Though the rest of Canada’s 10 million pre-ordered doses are coming at a later date, the 300,000 that arrived in Canada in late April also come at a time when several million more vaccines from other companies like Pfizer and Moderna were set to arrive in the coming weeks — raising the question of how best to use J&J’s dose.
Public health officials and experts have looked forward to the deployment of the Janssen shot in order to reach areas or groups of people that might face barriers in receiving a second dose.
Infectious disease expert Dr. Sumon Chakrabarti told the Canadian Press in April that the vaccine’s mobility would be instrumental in being able to deliver it to more targeted populations.
“You can transport the vaccine there and just boom, boom, boom, get it into people’s arms,” he said, noting that such a vaccine could be used in large, mobile vaccine clinics to inoculate hard-hit communities and essential workers.
“The timing doesn’t help — we really wanted to start (vaccinating) essential workers as quickly as possible. … But it’s something you can do (easily) with J&J.”
In a previous interview with Global News, infectious disease specialist Dr. Isaac Bogoch said that the vaccine “eliminates barriers that might prevent people from coming back for a second vaccination.”
“We know there are some populations that will have more challenges — through no fault of their own — for coming back for a second dose, like populations in prison, populations in shelters, migrant farmworkers. They would all be ideal candidates,” Bogoch said.
Experts have also touted that a one-shot vaccine could open the door for at-home vaccinations for frontline health workers to reach people at home, like the elderly population who might be immobile.
Yet despite its benefits, public health units won’t see this vaccine as soon as hoped — even as a third wave grips Canada, filling ICUs and setting daily case records.
“My understanding is Johnson and Johnson particularly was earmarked for hotspot areas — several that I noticed in western Canada — and it just slows all that down because the plan for Monday was for many places to really throw themselves into the J&J rollout in these hotspot areas, all of which is now on hold,” Bowman said.
“It’s another delay for Canada.”
— with files from The Canadian Press and Global News’ Rachael D’Amore and Saba Aziz