Pfizer has submitted early studies to Health Canada on the efficacy of its COVID-19 vaccination in children aged five to eleven years old.
The company announced on Saturday that it has submitted the preliminary trial data to the FDA for assessment as it prepared to submit a formal request for approval to use the medicine in youngsters.
Pfizer has stated that its formal submission will be made later this month.
Pfizer submitted preliminary data for children aged five to eleven on Friday afternoon, Health Canada said in an email, which was sooner than expected. The company’s submission is expected to be formally filed in mid-October, according to the department.
Pfizer Canada spokeswoman Christina Antoniou said the submission will be a request for full authorization.
She said the new drug submission process for COVID-19 vaccines offers the same flexibility as the interim order authorization pathway did, including allowing the company to submit a rolling submission.
“In other words, 1/8 it’s 3/8 not an emergency use authorization but a full approval under which we would continue to submit new data as it becomes available,” Antoniou said in an email.
Pfizer’s vaccine was initially given the green light for use in Canada last December under an interim order authorization and received full approval last month.
The two-shot vaccine, developed in partnership with German pharmaceutical company BioNTech, is currently available for those aged 12 and older.
The company is testing a lower dose of the shots in children.
Pfizer and BioNTech said last week that researchers found the vaccine antibody responses in children were just as strong as those found in teenagers and young adults getting regular-strength doses.
The companies submitted the research to the U.S. Food and Drug Administration last week and plan to request emergency use authorization of their vaccine in children ages five to 11 “in the coming weeks.” The companies also plan to submit data to the European Medicines Agency and other regulators.
Furthermore, research involving much younger youngsters is underway.
Pediatric studies investigating the safety and efficacy of Pfizer’s COVID-19 vaccination in children aged six months to five years are currently underway, with preliminary results expected by the end of the year, according to Antoniou.
In the meantime, in late August, Health Canada approved the use of Moderna’s COVID-19 vaccination in children as young as 12 years old.
The American pharmaceutical company is also conducting vaccine studies for youngsters under the age of 12, with results expected this fall.