mRNA COVID Vaccine Dosing Intervals May Be Extended To Mitigate Myocarditis Risk
While data suggests higher risk of myocarditis in young males receiving Moderna’s vaccine, US CDC advisory committee did not consider preferential recommendation. ACIP voted to recommend Spikevax for those 18 years and older following full FDA approval.
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The COVID vaccine development ‘miracle’ is already a core narrative of the pandemic era. But as the US prepares to apply lessons going forward, it is important to recognize the ways the process should not be a model for ‘normal’ operations, especially at FDA.
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.
Moderna fell behind Pfizer after receiving EUA for Spikevax, as it took three months longer to file its BLA and had an extra two months of FDA review for full approval. Novavax files request for FDA emergency use authorization of its vaccine.