Pfizer urges Health Canada to increase doses in each vial

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A healthcare worker prepares a dose of the Pfizer-BioNTech COVID-19 vaccine at a UHN COVID-19 vaccination clinic in Toronto on January 7, 2021.

Nathan Denette / The Canadian Press

Pfizer-BioNTech is pushing Health Canada to change the label of its COVID-19 vaccine and to 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 change the vaccine’s label, company spokeswoman Christina Antoniou said on Tuesday. The company’s contract with Canada is based on the delivery of doses rather than a set number of vials, she said.

“Obtaining six doses from the current multidose vial… can help minimize vaccine wastage and allow the most efficient use of the vaccine,” she said.

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Medical staff in Canada were sometimes able to withdraw six doses, but officials said that was inconsistent. However, Pfizer said that with specialized syringes, a sixth dose can be reliably extracted from each vial. These syringes are rare in the world.

The United States and the European Union have already accepted the requested change.

Canada buys 40 million doses from Pfizer. If Health Canada approves the change, Canada could get about 6.7 million vials instead of 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 immunization program, which has already experienced several slowdowns.

Squeeze every last drop

Each dose of Pfizer’s COVID-19 vaccine should be 0.3 ml. The company says that if low dead space syringes are used, six doses can be taken from each vaccine vial. However, if standard syringes are used, healthcare professionals may only be able to extract five doses.

0.092 ml of retained liquid

THE GLOBE AND THE MAIL, SOURCE:

PUBLIC HEALTH ENGLAND

Squeeze every last drop

Each dose of Pfizer’s COVID-19 vaccine should be 0.3 ml. The company says that if low dead space syringes are used, six doses can be taken from each vaccine vial. However, if standard syringes are used, healthcare professionals may only be able to extract five doses.

0.092 ml of retained liquid

THE GLOBE AND MAIL, SOURCE: PUBLIC HEALTH ANGLETERRE

Squeeze every last drop

Each dose of Pfizer’s COVID-19 vaccine should be 0.3 ml. The company says that if low dead space syringes are used, six doses can be taken from each vaccine vial. However, if standard syringes are used, healthcare professionals may only be able to extract five doses.

0.092 ml of retained liquid

THE GLOBE AND MAIL, SOURCE: PUBLIC HEALTH ANGLETERRE

Pfizer shipments have experienced delays and Canada will not receive any injections this week. Officials hope that the candidate vaccines from Johnson & Johnson and AstraZeneca will soon be approved in Canada, but so far no deliveries are expected until April.

A spokeswoman for Supply Minister Anita Anand said she could not comment until Health Canada decides whether or not to change the information on the product.

Late Tuesday, Martin Bégin, a spokesperson for Health Canada, confirmed that the regulator had 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 additional volume per vial acts as “a safeguard against the potential loss of volume that may occur during storage, preparation and administration. vaccine, and may result in exceedances which may amount to one or two additional doses. The product monograph would not change due to the additional volume in the vial. “

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If healthcare professionals use what’s called a low-dead space syringe to extract each dose, Ms Antoniou said, six doses can be drawn consistently. Dead space is a vaccine left in a syringe after an injection. “If standard syringes and needles are used, the volume may not be sufficient to extract a sixth dose from a single vial,” Ms. Antoniou said. Some needles can limit dead space.

Pfizer has not provided the Globe with data indicating how often six doses are taken from a vial. The Globe asked the governments of Ontario, British Columbia and Quebec, 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 that supplies the syringes to the United States. BD sells syringes in Canada, but not low dead volume syringes. The federal government was unable to tell the Globe which company provides them.

Of the 145 million syringes Canada has purchased for the immunization program, 37.5 million are needed if Health Canada approves Pfizer’s request, Ms. Anand’s office said. His office was unable to say on Tuesday when they would all be delivered.

Ms Antoniou said six low-dead space syringes are needed for each vial.

So far, syringes “have always had low demand,” Kirkpatrick said, and “no vaccine manufacturer has identified the need for these types of devices when production capacity has been increased.” He said the company was honoring its current contracts and informed governments that it “will take time” to increase production.

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Canada also purchased 40 million doses of vaccine from Moderna. On Tuesday, the company said its injections required standard syringes.

At the University Health Network in Toronto, one of Canada’s largest hospital groups, Emily Musing, vice president and professional pharmacist, said staff were able to get a sixth dose “more regularly” using a one milliliter syringe.

However, the hospital ran out and had to use three ml syringes. “We found that with the bigger syringes, we couldn’t take that many sixth doses,” she said.

None of these items are as reliable as the low dead space syringe, Ms Antoniou said.

Even without the need for a specialized syringe, some public health units faced supply issues. In Ontario, a health unit asks pet clinics for syringes specialized enough to get a sixth dose from a vial.

“In an effort to maximize the effectiveness of our vaccine delivery approach, we reached out to local veterinary clinics and community partners to request syringe contributions,” said Piotr Oglaza, public health medical officer of Hastings Prince Edward, which includes the town of Belleville.

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Andrew Blais, who works for a pet hospital in the area, said he was shocked to receive a request from the health unit on Monday asking the clinic to donate 1 cc syringes. “It was outrageous that they even thought of veterinary clinics,” he said. “I would have thought they might start with public health agencies or other government funded organizations [agencies]. »

“There was definitely a feeling of panic,” he says.

Alexandra Hilkene, spokesperson for Ontario Health Minister Christine Elliott, said it was Ottawa’s responsibility to procure syringes for vaccinations. However, she said the province could get additional supplies to help local public health units. She said Ontario sent three ml syringes to Hastings Prince Edward on January 22 and 25 for a total of 1,000. But these are not the specialized syringes to extract six doses.

The Alberta health authority said it was purchasing low dead space syringes and other supplies to supplement shipments from Ottawa.

The federal government has not disclosed how much it pays Pfizer for vaccines. A New York Times report suggests that cutting vials shipped by Pfizer will not change how much the United States pays. Reuters reports that Sweden is withholding payments until it obtains billing clarification from Pfizer. The company told a local newspaper it charges six doses per vial.

With reports by James Keller, Andrea Woo and Les Perreaux.

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