The new one-shot Johnson & Johnson vaccine should be offered only to people 30 or older who don’t want to wait for access to the Pfizer-BioNTech or Moderna vaccines, an expert panel says.
The guidance was released as Health Canada continued to investigate safety concerns connected to a U.S. plant where an ingredient used in Canada’s first shipment of the COVID-19 vaccine was made.
Late on Friday, Health Canada announced it was stopping distribution of 300,000 doses of the vaccine to provinces and territories because the regulator had learned the active ingredient was made at a Baltimore facility where an inspection raised concerns.
This means that, for now, no Canadians can get the Johnson & Johnson vaccine.
But if the federal regulator clears the doses, some doctors are worried that the quality-control investigation and the expert panel’s tepid endorsement could make Canadians reluctant to receive the shot, despite its efficacy against severe coronavirus disease and death in a clinical trial.
“J&J is terrific in that it provides significant protection, including against many of the variants of concern, and of course, it’s a one-shot deal,” said Isaac Bogoch, an infectious-disease physician at Toronto’s University Health Network and member of Ontario’s vaccine task force. “The concern is there may be increasing hesitancy toward using a vaccine that has tremendous potential to do good.”
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Canada’s National Advisory Committee on Immunization (NACI) recommended the Johnson & Johnson shot not be given to anyone under 30 because of the risk of extremely rare blood clots combined with low platelets, a syndrome dubbed vaccine-induced immune thrombotic thrombocytopenia (VITT). The advice attempts to balance the risk of VITT against the risk of getting seriously ill with COVID-19.
The recommendation mirrored the committee’s most recent advice on the AstraZeneca vaccine, which uses a similar viral-vector delivery mechanism and has also been linked to blood clots with low platelets.
NACI said Canadians who consider themselves at low risk from the coronavirus – such as healthy people who can work from home and live in places with relatively few cases – would be better off to wait for the mRNA-based Pfizer-BioNTech or Moderna vaccines, which have not been connected to VITT.
“What we’re saying, and what we’ve said all along, is that the mRNA vaccines are the preferred vaccines,” NACI vice-chair Shelley Deeks said at a news conference Monday. “The issue with the safety signal is that although it is very rare, it is very serious, and so individuals need to have an informed choice to be vaccinated with the first vaccine that’s available or to wait for an mRNA vaccine.”
Iris Gorfinkel, a Toronto family doctor and vaccine researcher, said NACI’s elevation of the mRNA vaccines undercuts the broader public-health message that the best vaccine is the first one offered, particularly in the midst of a third wave fuelled by faster-spreading and more dangerous variants.
“The messaging that I will personally continue to give – in spite of NACI’s recommendation – is what makes the most sense, both for the individual and for Canada as a whole, and that’s to get the first available vaccine. We cannot afford more hospitalizations and ICU visits. We’re already bursting at the seams.”
NACI’s advice differs from that of its U.S. counterpart, which last week voted in favour of resuming distribution of the Johnson & Johnson vaccine to all adults, with a warning about VITT directed at women younger than 50. As of April 21, the United States was aware of 15 cases of the clotting syndrome after nearly eight million injections. All were in women, 13 of them under 50 years old.
The European Medicines Agency, which also paused the rollout to investigate the adverse events, ended its suspension last week as well, but left it to member countries to set any limits on use.
The shot from Johnson & Johnson, made by the company’s Janssen division, is an important but small part of Canada’s vaccination strategy. Health officials hope to use the easy-to-store, single-dose vaccine for people who are less likely to return for a second dose or have a more difficult time accessing the second-dose appointments.
So far, Canada has received only 300,000 doses from Johnson & Johnson, out of the 10 million it has bought.
But the country is getting many more doses from Pfizer-BioNTech and Moderna. It is expected most people will get their shot with one of those two vaccines.
The active ingredient for the Johnson & Johnson vaccine, called a drug substance, was made at the Emergent BioSolutions Inc. plant in Baltimore at its Bayview campus. That plant was also making the AstraZeneca vaccine, and cross contamination occurred between the two production lines.
The New York Times reported in March that the mistake ruined up to 15 million doses of the Johnson & Johnson vaccine. The U.S. Food and Drug Administration conducted an investigation that found in part that the Emergent facility was “not maintained in a clean and sanitary condition” and the company didn’t properly investigate the cross-contamination.
In its statement Friday, Health Canada said it learned only last week that the drug substance for the Johnson & Johnson vaccine that was sent to Canada was made at the Emergent facility. The final manufacturing process for the vaccine was done outside the U.S., Health Canada said.
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