Health Canada says Pfizer's vaccine vials can be stretched to 6 doses

After an independent regulatory review, Health Canada has agreed with a request from Pfizer to recognize that each vial of the company's vaccine includes six doses, not five.

The labelling change means that more shots can be squeezed out of each vial and the company can ship fewer vials and still meet its contractual obligations to send a certain number of doses to its customers.

While some provinces notably Saskatchewan and Quebec have succeededin extracting more from each vial,Health Canada had been saying up to nowthat the vials are only good forfive doses.

Health Canada and other international regulators require vials to include a certain amount of overfill to ensure there is sufficient vaccine in each vial to yield the expected doses.

In its review, the regulator concluded that six full doses can be obtainedconsistently from the Pfizervials through the use of low-dead-volume syringes, which allow the user to pushvirtually allfluid out of the syringechamber. The government has scrambled to order large numbers of these syringesin recent weeks.

"Inorder to extract a sixth dose reliably and consistently, a specialized syringe should be used," said Dr. Supriya Sharma, Health Canada's chief medical adviser.

WATCH: Health Canada on syringes that will extract six doses from Pfizer vaccine vials

Fortin, Sharma on syringes that will extract six doses from one Pfizer vaccine vial

4 years ago

Duration 2:08

Major General Dany Fortin and Dr. Supriya Sharma, chief medical adviser at Health Canada, respond to the CBC's Hannah Thibedeau's question about extracting six doses out of a Pfizer vial.

Public Services and Procurement Minister Anita Anandhas said the federal government has ordered 64 million specialized syringes. One million were set to be delivered this week.

Change follows similar move in U.S. and Europe

Health Canada's move follows a similar label change bythe European Medicines Agency andthe U.S. Food and Drug Administration (FDA) late last year.

According to health officials, each Pfizer vial contains 0.25 mL of product, to which saline is added as a diluting agent to obtain2.25 mL of vaccine solution.

Each patient receives a 0.30 mL dose when they get a shot. That means there is enough product in a vialto comfortably cover six shots and still have a "buffer," and to accountfor possible wastage.

Sharma said there have been anecdotal reports of some jurisdictions squeezing a seventh shot from these vials.

While the label change comes into effect immediately, shipments to Canada for this week that have already begunare calculated at five doses per vial. Canada is expected to take delivery of70,000 doses this week.

The new designation means fewer vials could be shipped in the weeks ahead while the number of extractable dosesremains the same, as long as provinces are properly equipped with the syringes. Under its contract, Canada has ordered a certain number ofdoses from Pfizer not vials.

"While there is a change in doses contained in each vial, the country's overall allotment from the manufacturer remains the same," said Maj.-Gen Dany Fortin, the military commander leading vaccine logistics at the Public Health Agency of Canada.

"The distribution process though will not change, and vaccines will continue to be allocated on the basis of an equitable allocation framework that has been agreed to by all jurisdictions moving forward."

Conservative Leader Erin O'Toole said Tuesday he fearsthe policy shift will let Pfizer get away with sending fewer shots than promised.

Some provinces have saidextracting that sixth dose is often difficult a problem the federal government insists will be fixed with the new syringes.

"The Liberals must also be clear with Canadians about whether Pfizer will replace any lost doses if the provinces are unable to extract the sixth dose," O'Toole said.

Arianne Reza, a top bureaucrat at Public Services, told reporters Tuesday that the government will "monitor the situation" and work with Pfizer if there are any reports of missed doses as a result of the new standard.

O'Toolealsosaid he worriesthe labelling change could disrupt an already shaky vaccine rollout by forcinghealth care workersto "retrain and change tack in the middle of a pandemic."

Dr. Howard Njoo, Canada's deputy chief public health officer, said the federal government will launch a series of "webinars" in the coming days to train health care professionals on how to use the new syringes.

"I think the real live issue right now is to ensure our provincesand territoriescan reliably and consistently get six doses out of each vial," he said.

As part of this label change authorization, Pfizer is required to provide continued educational support to vaccine administration sites in Canada and to help the government toacquire more of the specialized syringes, if required.

WATCH: Maj.-Gen. Fortin says Canada is not receiving extra vials after label change

Fortin says Canada 'not receiving additional vials' after Pfizer's label change

4 years ago

Duration 1:13

Gen. Major Dany Fortin says Pfizer's COVID-19 vaccine label change does not mean Canada is receiving additional vials of the vaccine.

After weeks of smaller-than-expected shipments because of production delays, Fortin said Pfizer is prepared to significantly ramp up shipments in coming weeks as it looks to meet its promised goal of delivering fourmillion doses by the end of March.

"Starting on the 15th, we are expecting hundreds of thousands more doses each week and that's just from Pfizer," Prime Minister Justin Trudeau said. "Moving forward, we'll get more doses and get them even faster."

Fortin said Canada is on track to receive and distribute approximately 400,000 doses next week and 475,000 doses in the last week of February significantly more than what the company has delivered in recent weeks.

Canada falls to 37th worldwide for vaccines administered

According to the University of Oxford-based Our World in Data, Canada now ranks 37th globally in terms of vaccines administered well behind allies like the United States and the United Kingdom andsomemiddle-income countries like Turkey and Serbia.

Canada's vaccination effort has also been outpaced so far by those in Bahrain, Denmark, Germany, Israel, Italy, Malta, Poland, Portugal, Romania, Slovenia, Spain and the United Arab Emirates, among others.

Health Canada regulators are expected to approve another promising vaccine candidate soon AstraZeneca's product which could give a jolt to Canada's sluggish vaccination campaign.

Sharma said the product is in the "final stages" of the rolling review process but department officials still need more information from the company before they can give the green light.

"It does take some time. There's always some back-and-forth with the company at the end before we finalize the review," she said. "We're just waiting for the company to get back to us ... to finalize the terms of the labelling."

Sharma said concerns about the drug's efficacy against newCOVID-19 variantswill be incorporated into the department's review. On Monday, South Africa halted the rollout of the AstraZeneca product after it proved ineffective against the dominant strain of COVID-19 in that country.

Trudeau said the government is gearing up to vaccinate more people fasterto preventthese new variants from gaining a toehold here.

As some provinces begin to relax restrictions and ease lockdowns, Trudeau said Canadians must remain vigilant.

"I think we're all worried about the arrival of new variants and the impact that could have," he said.