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The American company Moderna announced that it will submit emergency requests for authorization for your vaccine against covid-19 in the United States and Europe, after complete results confirmed its high efficacy (94.1%).
Two weeks after announcing an efficacy of 94.5% based on preliminary results, Moderna reported that of 196 participants in its clinical trial who were infected with COVID-19, 185 belonged to the placebo group and 11 to the vaccinated group. with a calculated efficiency of 94.1%.
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This means that vaccinated people had their risk of contracting covid-19 reduced by 94% compared to people who were not vaccinated, an efficacy similar to that of the Pfizer / BioNTech vaccine (95%).
No severe form of the disease was recorded in the vaccinated group, against 30 in the placebo group. Moderna reported that no new serious side effects were seen in the vaccinated volunteers, but did not explicitly say whether serious side effects were initially seen. The most common reactions were pain around the injection site in the arm, fatigue, muscle stiffness or headache. One participant in the clinical trial died, but was in the placebo group.
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“This preliminary positive 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, CEO of Modern
This phase 3 study exceeded the mean follow-up of two months after vaccination required by health agencies for emergency use authorization. And in that sense, the pharmaceutical company said (read the statement here) that has already requested authorization to market its coronavirus vaccine both the United States Food and Drug Administration (FDA) and the European Medicines Agency.
Now these agencies will have to analyze the supplied mRNA vaccine test data and decide if it is safe and effective enough to recommend its implementation.
The FDA is expected to convene its vaccine advisory committee on December 17. This could allow, in case of a green light, a distribution in the following days.
It is worth noting that the Pfizer / BioNTech vaccine is already under evaluation by the FDA and could be authorized shortly after December 10.
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How is the vaccine?
Initially, Moderna had claimed that its experimental vaccine was 94.5 percent effective in preventing COVID-19, according to provisional data obtained from an advanced-stage trial, which made it two weeks ago the second US company to report results at these levels within a week. “This are very good news. If you look at the data, the numbers speak for themselves, ”said Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases.
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Moderna’s vaccine is based on new messenger RNA technology and its advantage is that it is reportedly it does not need ultra-cold storage, which would facilitate its distribution. In fact, Moderna expects it to be stable at standard refrigerator temperatures of 2-8 degrees Celsius for 30 days and can be stored at -20 degrees Celsius for 6 months. Adverse reactions were not significant in the preliminary data.
The United States government supported Moderna’s project through the National Institutes of Health with an initial $ 1 billion and in August $ 1.5 billion were added in exchange for 100 million doses, if the vaccine shows that it is safe and effective. Moderna is known to have made similar agreements with other countries.
HEALTH UNIT
