Confusion continues in Astrazeneca rollout
JUGGLING RISK AND EFFICACY, CANADA'S IMMUNIZATION PANEL MAKING TOUGH DECISIONS IT KNOWS WILL DRAW CRITICISM
It was born in the 1960s, an ensemble of the best and brightest minds in their fields tasked with providing advice to Canadians on routine childhood shots and other vaccines. Nearly 60 years later, the National Advisory Committee on Immunization is facing accusations of having “lost the plot” and clumsily mishandling the Astrazeneca rollout. Its volunteer cochair is fielding angry, frustrated emails from people urging her to resign. “You know what? I'd be very happy to resign, because this is not fun,” Dr. Caroline Quach-thanh said Wednesday in an interview with the National Post. “Yesterday I said I must have a blood pressure of 220 over 140 and I think I'm going to die of a heart attack. That's how bad it is. Because seriously, you try to take the best decision with the data, the imperfect data, making sure that nobody makes a mistake in their analysis. I mean the accountability is horrific.”
On Tuesday, NACI abruptly called off a news conference minutes before it was set to begin, and just as several provinces began opening bookings for the Oxford-astrazeneca shots to people 40 and over. Until then, eligibility had been limited to the 55 and older — based on NACI'S earlier advice concerning the rare risk of blood clots. See VACCINE on NP3
Much was made about how Ontario, British Columbia, Alberta and now Manitoba's move to a lower age floor was made mere hours after Canada's federal health minister, Patty Hajdu said provinces and territories were free to use Astrazeneca's vaccine on anyone aged 18 and above that they saw fit. But Quach-thanh said the provinces were acting on guidance offered by NACI that was delivered to the Public Health Agency of Canada on Saturday, and shared with the provinces and territories Sunday.
The provinces knew NACI had planned to make the new recommendation public Tuesday, “but there was this urgency, so that was OK,” she said.
Things got more puzzling Tuesday, after NACI hurriedly postponed its media briefing after receiving late data that provided “a bit more clarity” on the situation unfolding in Ontario, Quachthanh said, including rising ICU admissions driven by super-contagious variants. “It will change the overall risk-benefit analysis,” she said. Meaning, that 40-lower age floor might get lowered, again, based on the disease incidence or new cases per day in a given community. NACI is working on having its statement out later this week.
It all seems so unnecessarily confusing. Critics have accused the volunteer panel of muddying the messaging, of issuing recommendations based on stale data. “To me what they come out with now is moot … We just don't have that national leadership,” respirologist Dr. Samir Gupta said Wednesday on CBC Morning Live.
“There actually is no serious debate about the AZ vaccine any longer,” University of Ottawa lawyer and health policy expert Amir Attaran said in an email. “There is a risk of blood clots, and the only `debate' is whether that risk is extremely low (one in a million) or merely very low (one in a few hundred thousand).” Either way, the risk is far less than the risk of being infected with COVID and getting a clot from COVID, he said.
“I see a lot of advantage in having a vaccination advisory panel to make thoughtful, slow decisions in normal times. But the people who excel at that in normal times are often the wrong people to make decisions in a pandemic when speed matters; the slow thinkers cause damage by making the perfect the enemy of the good,” Attaran said.
Pivoting might be seen by some as a reason to lose faith in the credibility of the group, said Dr. David Juurlink. “On the other hand, pivots are sometime justified by an objective assessment of the data. I wouldn't be so critical of them,” said Juurlink, a pharmacologist and internist at Toronto's Sunnybrook Health Sciences Centre and an expert in rare drug reactions.
Safe is not a binary thing — safe, unsafe, he said. “Everything entails some risk.” While Health Canada last week stood by its approval of Astrazeneca for all adults, saying the vaccine meets its “strict safety standards,” Juurlink said the issue deserves a little more nuance. “To say it's safe in all age groups, I tend to side more with NACI than Health Canada on that.”
What, or who, is NACI? Its members consist of 12 voting members from across Canada. Children's doctors are still prominent in the current ranks — Quach-thanh is a pediatric infectious diseases specialist at Montreal's CHU Sainte-justine hospital — but other members include Toronto associate medical officer of health Dr. Vinita Dubey, and Dr. Kristin Klein, a local medical officer of health for northern Alberta.
Their advice isn't binding, their meetings are closed to the public and, PRE-COVID, they met face-to-face three times a year. Since December, the independent, volunteer panel has met more than a dozen times and has scheduled 10 more virtual meetings between now and the end of June.
“For those inclined to be critical of NACI, I'd just observe that this is an unprecedented situation, with more vaccines arriving faster than has ever happened in human history,” said Dr. David Naylor, co-chair of Canada's COVID immunity task force. “I cannot imagine how stressed and stretched these colleagues have been in the last year. The whole country owes them a debt of gratitude, and we need NACI to keep doing what they do so well in peacetime.”
Naylor said the panel is trying to make judgments about very rare events with incomplete data and “wobbly models” for competing risks.
In public health emergencies, hours and days matter, “particularly when vaccine doses are not infinitely available,” Naylor said. Public safety and vaccine confidence also matters, a lot, he said. “I think reasonable people accordingly may well disagree on whether Canada gets points for prudence here, or whether the handling of Astrazeneca illustrates a need for faster decision-making and better coordination.”
Scientists are still trying to sort out the biology around the blood clot risks, why it happens, as well as the true incidence rate. Canada has three confirmed cases so far linked to Astrazeneca: a Quebec woman, an Alberta man in his 60s and, on Tuesday, New Brunswick confirmed a case in someone aged 30 to 39 vaccinated in mid-march.
“It's easy to say, why don't you just use it (Astrazeneca in all adults),” Quach-thanh said. “What we don't want is to put something under the carpet and then something happens and people say, `why didn't you tell me that I could die or be severely injured from a clot that you knew existed?'”
“We now have three cases (of blood clots) in Canada,” Quach-thanh said. “Nobody died, that's perfect. I think two out of the three went to the ICU. But we can't ignore the safety signal. We didn't make that up.” “Seriously, I would have been much more happy if nothing had happened and if this vaccine had sailed through without any particular incidents,” Quach-thanh said.
She said she understands the anxiety.
But, “I don't think people realize what it means to try and make decisions for the country. We have to have consensus, we have to have the data … we can't really make it any faster.”
I DON'T THINK PEOPLE REALIZE WHAT IT MEANS TO TRY AND MAKE DECISIONS FOR THE COUNTRY.