Pfizer has submitted preliminary data to Health Canada regarding the safety and effectiveness of its COVID-19 vaccine in children aged five to 11.
A spokesperson for the pharmaceutical company told Daily Hive that initial trial data has been sent to the federal regulator for review.
In an email, Health Canada confirmed to Daily Hive that it received the preliminary data on October 1, which they noted was “earlier than expected.”
The move is in advance of a formal submission to authorize the company’s vaccine in children. According to Pfizer’s spokesperson, that submission could come later this month.
“Pfizer continues to work with Health Canada as we prepare to file our submission for potential authorization of the vaccine in this population,” the spokesperson said.
“We are aiming to file this submission by mid-October.”
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Pfizer and its partner, BioNTech, announced on September 20 that their COVID-19 vaccine is safe for use in children aged five to 11.
The news came as the companies revealed the results of a phase 2/3 clinical trial, which showed that children demonstrated a “strong immune response” to their vaccine.
At the time, Pfizer chairman and CEO Albert Bourla said a recent rise in pediatric cases of COVID-19 in the US “underscores the public health need for vaccination.”
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Bourla sais.
At a press conference on October 1, Health Minister Patty Hajdu said federal regulators are “well situated “to “very quickly review” submissions for COVID-19 vaccines in children.