Covid vaccine: Moderna seeks approval in US and Europe


MODERNA is filing for US and European emergency regulatory approval of its corona virus vaccine so that it can be recommended for widespread use.
Regulators will look at trial data for the mRNA vaccine and decide if it is safe and effective enough to recommend for roll out.
Clinical studies show the jab is more than 94% effective at protecting people from becoming ill with Covid-19.
Pfizer, which has a similar jab, has already filed for the same US approval.
UK regulators are also reviewing data on the Pfizer vaccine, as well as another type of Covid vaccine from AstraZenca and Oxford University for emergency approval.
Moderna says it hopes to gain UK approval soon, now that it has trial data from 30,000 volunteers – including high risk groups like the elderly – that suggests it works. In those studies, 15,000 people received the real vaccine while the other participants got placebo injections. No serious side effects were reported. During the studies, 185 people in the placebo group fell ill with Covid-19, and some severely so.
In comparison, there were 11 cases in the vaccine group and none were severe.
Full trial data has not been released, but will be published in a peer-reviewed journal in due course.
Moderna announced the completion of their phase 3 clinical trial primary efficacy analysis. The vaccine candidate is 94.1% effective against Covid-19 and 100% effective against severe Covid-19. The company will apply today for emergency use approval in the United States.
In addition, it will also apply to the European Medicines Agency for conditional marketing authorization.
Moderna highlighted that 196 people enrolled in their 30,000-participant trial have now had Covid-19. Of them, 11 were in the group that had received the vaccine.
There were 30 cases of severe Covid-19, all in the placebo group. One person in this group died.
The 196 cases of Covid-19 in the study occurred among diverse participants, including older adults and those from minority ethnic groups.
The company stressed that they will submit the results of the study to a peer reviewed journal.
As the world awaits the imminent arrival of one or several Covid-19 vaccines, many people may wonder how important vaccines actually are to safeguarding public health.


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