Moderna seeks OK to give teens its COVID-19 vaccine in Canada
The drugmaker Moderna has filed for Health Canada authorization for its COVID-19 vaccine to be used in adolescents.
In a statement on Monday, the company said results from a clinical trial in the U.S. last month showed their two-shot vaccine was effective in adolescents between the ages of 12 and 17.
According to the results, there were no cases of COVID-19 observed in participants who had received two doses of the Moderna vaccine. The vaccine efficacy in the nearly 2,500 adolescents who received it was observed to be 100 per cent, the company said.
Additionally, the company said the vaccine had a 93 per cent efficacy two weeks after the first dose in adolescents who tested negative for ever having COVID-19.
Moderna said the vaccine was “generally well tolerated” and there were no significant safety concerns.
“Moderna Canada’s submission to Health Canada for authorization to use our COVID-19 vaccine with Canadian adolescents represents an important step forward in meeting Canada’s public vaccination goals,” Patricia Gauthier, Canadian General Manager for Moderna Inc., said in a statement.
“The Phase 2/3 study results we submitted show that the Moderna COVID-19 Vaccine was highly effective in preventing COVID-19 and SARS-CoV-2 infection in adolescents aged 12 to 17, similar to the efficacy and tolerability profile in the adult populations. We look forward to bringing it to Canadians.”
The drugmaker said they have also filed for conditional marketing approval in Europe and will file for emergency use authorization from the U.S. Food and Drug Administration.
Currently, the Pfizer-BioNTech COVID-19 vaccine is the only one approved for use in Canadians under the age of 18 after Health Canada authorized it could be administered to those 12 and older in early May.
--with files from CTV News--