Moderna’s COVID Vaccine Sheds Negative Comparison On Myocarditis With BLA Approval
Unlike the current EUA fact sheet, Spikevax’s approved labeling does not state that the vaccine may pose an increased risk of myocarditis ‘relative to other authorized or approved mRNA COVID-19 vaccines.’ Approval brings Moderna a priority review voucher, as did Comirnaty’s approval for BLA sponsor BioNTech.
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The change to three vaccine emergency use authorizations was made quietly, most recently for the Novavax vaccine.
The agency also includes a myocarditis warning in the fact sheet for the first protein-based COVID-19 vaccine to reach the US market.
The company hopes to expand Spikevax’s reach beyond the current approved population while also looking to take the lead in mRNA vaccines in other diseases.