FDA finds Moderna Covid-19 vaccine safe and effective
By Alexander Bueso
Date: Tuesday 15 Dec 2020
(Sharecast News) - US regulators confirmed the high efficacy and safety of Moderna's vaccine candidate in preventing Covid-19.
Ahead of the meeting of an advisory panel of outside experts, the US Food and Drug Administration, scheduled for 17 December, the FDA said the vaccine had an efficacy of 94.1% among those 18 years and older.
The vaccine's efficacy among those 65 years old and over was put at 86.4% and for those between 18 and 65 years of age at 95.6%.
The FDA was not necessarily obliged to follow the panel's advise on whether or not to grant so-called emergency use authorisation, but usually did do so.
If EUA were granted, Moderna's vaccine would become the second vaccine that was available, alongside the one developed by Pfizer and BioNTech.
However, unlike the Pfizer-BioNTech's vaccine, Moderna's had not yet been approved by regulators in any other country.
Safety was not an issue either, with the most common side effects being fatigue and headache and the number of serious adverse events thought to be linked
To arrive at its findings, the FDA was given much deeper access to the clinical trial data from Moderna than had to date been made public.
However, there wasn't yet sufficient data to determine if the vaccine also blocked transmission of Covid-19, although some asymptomatic infections appeared to be prevented after volunteers were given their first of two vaccine doses.
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