Pfizer’s vaccine for children five years and older could be ready for approval in about a week

The first COVID-19 vaccine for children under 12 could be in front of Health Canada’s review team in just a few days, and Pfizer hopes to begin shipping a new pediatric formulation of its vaccine shortly after it receives the green light.

But some Canadian pharmacists hope that Canadian authorities will authorize them to prepare pediatric-size doses from the vaccine vials already shipped to Canadians 12 years and older.

Pfizer submitted data from a clinical trial involving children ages five to 11 last week, and made the formal application for it to be licensed for that age group in the US on Thursday.

The company’s Canadian spokeswoman said the company is working with Health Canada on the final steps before the formal application is made here.

“Our goal is to submit this application in mid-October,” said Christina Antoniou.

The vaccine was developed in association with BioNTech of Germany and is now marketed under the brand name Comirnaty. It was authorized for people of at least 16 years old last December, and for children between 12 and 15 years old in May.

Pediatric data in children between the ages of 5 and 11 showed a safe and strong immune response with two doses, which are one-third the size given to adolescents and adults.

More than 80 percent of Canadians over the age of 12 are now fully vaccinated against COVID-19, and as vaccines help delay infections in adolescents and adults, the rate of infection among children has increased.

Kristen Watt, a pharmacist and owner of Kristen’s Pharmacy in Southampton, Ontario, said she’s getting a lot of questions from parents about the vaccine and whether to enroll their children when the time is right.

“We know from the questions we receive that it is going to be an uphill battle,” he said in an interview. “So getting ahead of what the launch plan looks like is really very important. We really need this to be smooth, straightforward and hassle-free.”

He said that while it is true that the disease tends to be milder among children in general, there are children who become seriously ill and end up in the hospital and others who end up with long-term symptoms.

#Pfizer will seek approval of its vaccine for children up to five years of age in about a week. # COVID19 #NACI

“So far we have done a lot to mitigate the spread in children, so why wouldn’t we make this our top priority to continue to reduce the risk to children?” He asked.

Watt does not think there is a good reason why Canada should risk delaying delivery of doses by waiting for Pfizer to deliver more vials specifically for children, when pharmacies and public health clinics can easily use the same syringes to draw the most doses. small of the vaccine.

Pfizer has delivered more than 46 million doses to Canada to date, and an analysis of available data from the federal and provincial governments suggests that there are already more than enough doses of Pfizer in Canada to vaccinate children aged five. and 11 years.

But that is not what Pfizer is asking for in its presentation to Health Canada.

“The launch of new formulations, including the doses of our vaccine for this age group, has been incorporated into the supply agreement that Pfizer and BioNTech have with the government of Canada,” said Antoniou.

“A delivery schedule for the pediatric formulation will be determined shortly after regulatory approval is granted with the intention of getting the doses to Canada as quickly as possible.”

Canada signed a new contract with Pfizer for pediatric dosing last spring.

Watt said waiting for new deliveries will delay vaccines and that pharmacists could vaccinate the day after it is approved if they can use the vials they already have. Existing vials contain six adult-size doses, but could hold three times as many doses for children.

He said he hopes the National Immunization Advisory Committee will intervene soon to clarify whether that can happen. He said a concern may be contamination if a vial is accessed 18 times instead of six, but that can be mitigated with adapters.

This Canadian Press report was first published on October 7, 2021.

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