Pfizer-BioNTech is pushing Health Canada to amend its COVID-19 vaccine label and formally recognize that each vial contains six doses rather than five, which would allow the company to send fewer vials to Canada but could complicate the vaccination program.
Pfizer submitted a request to Health Canada on Friday to amend the vaccine label, company spokesperson Christina Antoniou said on Tuesday. The company’s contract with Canada is based on delivering doses, rather than a set number of vials, she said.
“Obtaining six doses from the current multi-dose vial … can help minimize vaccine wastage and enable the most efficient use of the vaccine,” she said.
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Medical staff in Canada have sometimes been able to withdraw six doses, but officials have said it’s not consistent. However, Pfizer said with specialized syringes, a sixth dose can be reliably pulled from each vial. These syringes are in short supply around the world.
The United States and European Union have already accepted the requested change.
Canada is buying 40 million doses from Pfizer. If Health Canada approves the change, Canada could get about 6.7 million vials rather than eight million. The change could increase the number of people who can receive the vaccine worldwide. However, it could also be a challenge for Canada’s vaccination program, which has already hit several speed bumps.
Each dose of Pfizer’s COVID-19 vaccine must be 0.3 ml. The company says if low-dead space syringes are used then six doses can be withdrawn from each vial of the vaccine. However, if standard syringes are used then medical professionals may only be able to extract five doses.
Shipments from Pfizer have had delays, and Canada will get no shots this week. Officials hope vaccine candidates from Johnson & Johnson and AstraZeneca will soon be approved in Canada, but so far no delivery is expected before April.
A spokesperson for Procurement Minister Anita Anand said she could not comment until Health Canada decides whether to change the product information.
Late Tuesday, Martin Bégin, a spokesperson for Health Canada, confirmed the regulator has received Pfizer’s request. He was unable to provide a timeline for a decision.
In a statement to The Globe on Monday, Health Canada spokesperson Maryse Durette said the extra volume per vial acts as “a safeguard against the potential loss of volume that can occur during storage, preparation and administration of the vaccine, and can result in overages that may amount to an extra dose or two. The monograph of the product would not change because of extra volume in the vial.”
If health professionals use what’s called a low dead space syringe to extract each dose, Ms. Antoniou said, six doses can be consistently drawn. Dead space is a vaccine that is left in a syringe after injection. “If standard syringes and needles are used, there may not be sufficient volume to extract the sixth dose from a single vial,” Ms. Antoniou said. Some needles can limit dead space.
Pfizer did not provide The Globe with the data to show how often six doses are retrieved from a vial. The Globe asked the Ontario, B.C., and Quebec governments, but they did not provide such information.
The low dead space syringes are a “niche” item, said Troy Kirkpatrick, a spokesperson for BD, the medical technology company supplying the United States with syringes. BD is selling syringes to Canada, but not low dead space ones. The federal government was unable to tell The Globe which company supplies those.
Of the 145 million syringes Canada has bought for the vaccination program, 37.5 million are the kind that would be required if Health Canada approves Pfizer’s request, Ms. Anand’s office said. Her office was unable to say on Tuesday when they would all be delivered.
SOURCE: THE GLOBE AND MAIL
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