While the Pfizer / BioNTech vaccine is already being evaluated by the US administration and could be authorized shortly after December 10, it will be Moderna's turn to file a similar authorization request in the United States on Monday and in Europe.
Two weeks after announcing 94.5% efficacy based on preliminary results, Moderna reported that out of 196 participants in its large clinical trial who fell ill with Covid-19, 185 were in the placebo group and 11 in the vaccinated group. , or a calculated efficiency of 94.1%.
This means that vaccinated people saw their risk of contracting Covid-19 reduced by 94% compared to unvaccinated people, an efficiency similar to that of the vaccine from Pfizer / BioNTech (95%, which is statistically similar).
No severe form of the disease occurred among the vaccinated group of participants, compared to 30 in the placebo group.
Moderna reported that no new serious side effects were observed in the vaccinated volunteers, but did not explicitly say whether serious side effects were observed initially.
On November 16, she announced that the vaccine was "generally well tolerated" and had raised "no significant safety concerns".
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Minor side effects
The most frequent reactions were not serious, such as pain around the injection site in the arm, fatigue, muscle stiffness or headache.
One participant in the clinical trial died, but he was in the placebo group.
Moderna reports that the observed efficacy of his vaccine was consistent across age, gender and ethnicity.
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"This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 with an efficiency of 94.1% and, significantly, the ability to prevent the severe form of Covid-19", said Stéphane Bancel, the boss of Moderna.
The company will file what is called in the United States an emergency authorization request to the Medicines Agency (FDA), which is expected to convene its advisory committee on vaccines on December 17.
This could allow, in the event of a green light, a distribution in the following days.
Moderna will also submit a conditional use request to the European Medicines Agency (EMA) on Monday.
Together, the vaccines from Pfizer-BioNTech and Moderna could immunize 20 million Americans by the second half of December.