Pfizer to seek approval for kids vaccine in a week

By Mia Rabson

OTTAWA – The first COVID-19 vaccine for kids under 12 could be in front of Health Canada’s review team in just days and the company expects to start shipping its new pediatric formulation of the vaccine shortly after it gets the green light.

The U.S. drugmaker submitted data from a clinical trial involving kids five to 11 years old last week, and made the formal request for it to be authorized for that age group in the U.S. Thursday.

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

“We are aiming to file this submission by mid-October,” said Christina Antoniou.

The vaccine, which Pfizer now refers to by the brand name Comirnaty, was authorized for people at least 16 years old last December, and for kids between 12 and 15 in May.

The pediatric data on kids between five and 11 showed a safe and strong immune response from two doses, which are one-third the size given to teens and adults.

More than 80 per cent of Canadians over 12 are now fully vaccinated against COVID-19, and that has been partly why the infection rate among kids under 12 has been growing.

In Ontario, in the latter half of September, about one in five new cases were in kids under the age of 12, compared with fewer than one in six new cases in midsummer.

In Alberta, children between five and nine have the highest new infection rate of any age group.

Most children infected with the virus that causes COVID-19 experience very mild, cold-like symptoms, if any, but it can cause severe disease in some children.

Pediatricians have also warned about the existence of long-term COVID symptoms in some children, as well as the risk some children infected will develop multi-system inflammatory syndrome which can be fatal.

More than 29.4 million Canadians over the age of 12 now have at least one dose of vaccine and Pfizer has been the most common vaccine used in Canada to date, accounting for at least half of the doses administered to date.

Moderna is also testing a pediatric formula of its vaccine, but hasn’t yet published any clinical trial data. It is hoping to have results ready by the end of the year.

Vaccine trials for children as young as six months are also underway.

Canada has more than 18 million doses of vaccine, mostly Pfizer and Moderna sitting in freezers, but they aren’t currently on tap for use on kids under 12.

“The rollout of new formulations, including 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,” Antoniou said.

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

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