The biotechnology company Moderna assured this Monday that it is about to request the Food and Drug Administration (FDA) for the emergency authorization of its coronavirus vaccine.
It will be the second US company to complete this step
, increasing the chances that such products will be available to fight the COVID-19 pandemic as early as the end of this year.
Pharmaceutical Pfizer requested emergency use of its vaccine on November 20.
In a statement, Moderna stated that new data obtained after completing phase 3 of the vaccine study shows that its efficacy is 94.1%.
In addition, he indicated that the effectiveness is 100% when it comes to avoiding "severe" cases of this disease.
These results were the same regardless of the age, ethnicity and gender of the participants who received the vaccine, the company said.
So far there have been no serious safety concerns
, he added, and the most common side effects are fatigue, muscle and joint pain, and headaches.
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Moderna's trial involved 30,000 people, half of whom received the vaccine and the other half a placebo.
Those responsible for its development detected 196 cases of COVID-19, of which only 11 were from the group to which the antidote was administered.
There were 30 cases of severe illness, all of them in the placebo group.
So of the 15,000 people who received the vaccine,
none became seriously ill during the trial period
, the company said.
Two weeks ago, the biotech said the vaccine was 94.5% effective in preventing infection, according to a preliminary analysis of phase 3 data.
Pfizer, for its part, indicated that its effectiveness is 95% effective.
Other producers of a COVID-19 vaccine, the company AstraZeneca and the University of Oxford (UK), also reported promising preliminary data, but a few days later they admitted that there was a technical problem and that more tests are needed (although the safety of the same does not seem in discussion).
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These developments have been greeted with widespread optimism among scientists and also by the stock markets.
But experts also call for caution
until more data is released, beyond the triumphant press releases of the various companies not independently reviewed.
It should also be borne in mind that, no matter how much they are approved by the authorities, distributing the vaccine to hundreds of millions of people in dozens of countries
will pose a challenge without precedent in terms of logistics and outreach capacity
, particularly in some areas of the world. most disadvantaged planet.
With information from NBC News.