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EMA approves extended filing for Spikevax as booster for COVID-19.
Moderna announced that the European Medicines Agency (EMA) has authorized a third dose of Spikevax, the Moderna COVID-19 vaccine, given at least 28 days after the second dose to severely immunocompromised individuals 12 years of age or older.
A growing number of studies have shown the benefit of a third dose of COVID-19 vaccine in immunocompromised subjects.
In particular, a recent double-blind, randomized controlled trial of 120 individuals who had undergone solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) demonstrated that a third dose of the Moderna COVID-19 vaccine improved immune response compared to placebo. In the study, the third dose was generally well tolerated.
Condition: Coronavirus/COVID-19 Infection
Type: drug
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