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The American firm Moderna has announced that it will submit emergency requests for covid-19 vaccine authorization in the United States and Europe, after complete results confirmed its high efficacy (94.1%).
Two weeks after announcing 94.5% effectiveness based on preliminary results, Moderna reported that of the 196 participants in his clinical trial who were infected with COVID-19, 185 were in the placebo group and 11 were in the vaccinated group. with a calculated efficiency of 94.1%.
This means that vaccinated people had a 94% reduced risk of contracting covid-19 compared to people who had not been vaccinated, an efficacy similar to that of the Pfizer / BioNTech vaccine (95%).
No severe disease was recorded in the vaccinated group, compared with 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 initially observed. The most common reactions were pain around the injection site in the arm, fatigue, muscle stiffness or headache. One clinical trial participant died but was in the placebo group.
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This phase 3 study exceeded the median follow-up of two months after vaccination required by health agencies for emergency use authorization. And in that sense, the drug company said (read the statement here) that has already applied for authorization to market its coronavirus vaccine both the US Food and Drug Administration (FDA) and the European Medicines Agency.
Now these agencies will have to analyze the test data from the mRNA vaccine provided and decide whether 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 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 may be authorized shortly after 10 December.
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If the process goes smoothly and approval is granted, the first injections can be given from 21 December, said Stéphane Bancel, CEO of Moderna, in an interview with the “New York Times”. According to the company, the vaccine’s efficacy “was consistent” based on age, race and ethnicity and gender demographics, and while reviews are underway, “no serious problems have been identified.”
How is the vaccine?
Moderna had initially said its experimental vaccine was 94.5 percent effective in preventing COVID-19, according to provisional data obtained from an advanced-stage study, making it the second largest U.S. company two weeks ago to within a week. the results of these levels. “This is great 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.
(See: Guilds Demand That Covid-19 Vaccine Decisions Be Made Together)
Moderna’s vaccine is based on new messenger RNA technology and its advantage is that it is it does not require 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 U.S. government backed Moderna’s project through the National Institutes of Health with an initial $ 1 billion, and $ 1.5 billion was added in August in exchange for 100 million doses, if the vaccine shows it’s safe. and effective. Moderna is known for having made similar agreements with other countries.
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