Benzinga | Nov 15, 2021 11:17AM EST

Health Canada Authorizes Booster Dose Of Moderna's COVID-19 Vaccine In Individuals 18 Years Of Age And Older

Moderna Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today confirmed that Health Canada authorized the use of a booster dose of the Moderna COVID-19 vaccine (SPIKEVAX(tm)) at the 50 ?g dose for individuals aged 18 and older administered at least six months after completion of the primary series.

"We would like to thank Health Canada for this authorization and the Government of Canada for its continued confidence in our mRNA platform," said St?phane Bancel, Chief Executive Officer of Moderna. "We are grateful for the opportunity to provide Canadians with another layer of protection."

Health Canada based this authorization on the totality of scientific evidence shared by the company, including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 ?g dose level to interested participants 6-8 months following their second dose. Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 ?g dose level boosted neutralizing titers significantly above the Phase 3 benchmark. After a booster dose, a similar level of neutralizing titers was achieved across age groups including in older adults (ages 65 and above). The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.