Health Canada approves Moderna’s bivalent COVID-19 booster for BA.4, BA.5 subvariants

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Health Canada has authorized Moderna’s bivalent COVID-19 booster vaccine for those 18 years old and older after approving Pfizer’s in October.

Moderna’s booster will also target the Omicron BA.4 and BA.4 subvariants of COVID-19.

Health Canada deemed the “Spikevax” booster “safe and effective” after a “thorough and independent scientific review of the evidence.”

“Clinical trial results showed that a booster dose of the bivalent Moderna Spikevax vaccine triggers a strong immune response against both Omicron (BA.4/BA.5) and the original SARS-CoV-2 virus strains,” Health Canada said in a statement Thursday.

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“This adapted vaccine has a similar safety profile to the previously approved Moderna Spikevax boosters, with the same mild adverse reactions that resolved quickly.”

Health Canada said it and the Public Health Agency of Canada will closely monitor the vaccine’s safety and promises to take action if any concerns are identified.

Moderna is projecting US$4.5 billion to US$5.5 billion in sales from COVID-19 vaccine contracts in 2023, down from analysts’ estimates of US$9.5 billion as demand has dropped and production has been stalled due to quality control issues at its contract manufacturing partner.

— With files from Reuters

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