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EMA Recommends Conditional Marketing Authorization For Moderna's COVID-19 Vaccine

The European Medicines Agency or EMA has recommended granting a conditional marketing authorization for Moderna's COVID-19 vaccine. It is the second COVID-19 vaccine that EMA has recommended for authorization.

The European Commission in late December granted a conditional marketing authorization for Pfizer and BioNTech's COVID-19 vaccine Comirnaty, also known as BNT162b2, for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.

The EMA said Wednesday that a very large clinical trial showed that Moderna COVID-19 vaccine was effective at preventing COVID-19 in people from 18 years of age. The trial involved around 30,000 people in total.

Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection.

The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine compared with people who received dummy injections. This means that the vaccine demonstrated a 94.1% efficacy in the trial.

The trial also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.

The EMA noted that the COVID-19 vaccine Moderna is given as two injections into the arm, 28 days apart. The most common side effects with the vaccine were usually mild or moderate and got better within a few days after vaccination.

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