Canada loses its bonus dose

SIX IN A VIAL

OTTAWA • Canada has agreed to let drug giant Pfizer relabel its COVID-19 vaccine, allowing the company to ship the same amount of product here, but get credit for another dose in every vial.

When Pfizer first applied for regulatory approval for its vaccine, the company indicated every vial contained five doses. But nurses giving the shots quickly found they were able to extract a sixth dose, especially with so-called special low-dead space syringes.

Pfizer asked Health Canada to recognize that change and on Tuesday, the agency agreed following the same move from regulators in the U.S. and European Union.

Pfizer's contract with Canada and other countries is based on the doses it delivers, not the individual vials, meaning the company can now more quickly meet its contractual obligations. The company isn't changing its manufacturing process, but is committed to working with the provinces on any complaints if the vials come up short.

Dr. Supriya Sharma, Health Canada chief medical advisor, said they worked with the company and looked at volumes of research on the issue and were convinced, with the right equipment and training, it should be possible to get the extra dose.

“In the review, it was determined six full doses can be obtained reliably and consistently from each vaccine vial.”

Each dose of the vaccine is a very small amount of liquid, just 0.3 millilitres of vaccine combined with a saline solution. Some wasted vaccine is inevitable in the process of injecting the shots, but Health Canada is confident there will still be room for that even with the sixth dose being added.

When the possible change was first announced several provinces expressed doubts about their ability to consistently get six doses from each vial. Sharma said the company made a strong case to Health Canada that the extra dose would be there.

“What the company has come in and has demonstrated through their studies is that if you're using those syringes reliably, using the good technique in terms of drawing up the dose and administering them, then you should be able to get that sixth dose reliably.”

Alexandra Hilkene, a spokesperson for Ontario Health Minister Christine Elliott, said they expect the federal government to deliver the special syringes, but believed this was a positive step.

“We are encouraged by this development from Health Canada and remain ready to administer the COVID-19 vaccine and expand vaccination sites as soon as we receive supply from the federal government,” she said in an email.

Marla MacInnis, a spokesperson for the Nova Scotia government, said they were working to get more of the special syringes and ultimately the decision meant a faster vaccine effort.

“We are working with the National Operations Centre to access low-dead volume syringes and to procure an additional supply on our own,” she said. “This will mean more Nova Scotians will receive their vaccine sooner.

A source in the Alberta government was more critical. They said the province was more consistently getting the sixth dose from vials, but it was not happening every time. They suggested Health Canada accepting the change was proof the federal government had little leverage in its dealings with vaccine manufacturers.

Conservative leader Erin O'Toole said the government should offer more detail and should have pushed to ensure Pfizer meets its full commitment and makes up any doses lost as part of this change.

“Today's announcement means that the Liberal government is allowing Pfizer to send fewer vials of vaccines to Canada,” he said in a statement. “Mandating that the provinces do more with less means health care workers will need to retrain and change tack in the middle of a pandemic.”

Maj.-Gen. Dany Fortin, who is overseeing the government's vaccine distribution effort, said the government had placed large orders for the low dead-space syringes and had already received millions that could be moved out to provinces. The government was also planning training webinars for health-care workers to help them consistently get the doses in arms.

“What we are doing is ensuring that we have the right equipment, the right training at all levels, so that we can draw a maximum amount of doses out of every vial.”

The change will be felt beginning next week: a shipment that was expected to include 335,000 doses will now contain 400,000, without any increase in the number of vials sent to Canada.

The following week, what was to be a 400,000-dose shipment, will become 475,000 doses.

If Pfizer stays on that pace through next month, it will meet and exceed its commitment to provide four million doses by the end of March.

The government is still waiting to hear how many doses of the Moderna vaccine it can expect in the next shipment, the week of Feb. 22. Moderna is dealing with supply chain issues that have reduced the volume of some shipments.