The Moderna company – one of the companies with a potential vaccine against covid-19 – announced on Wednesday that it has received confirmation from the European Medicines Agency (EMA) that its potential vaccine, mRNA-1273, is eligible for an authorization application. European Union marketing.
Moderna’s application for authorization includes updated clinical information about the vaccine, including the results of a preclinical study and analysis of phase 1 trials in healthy adults (aged 18 to 55) and elderly (two groups: between 56 and 70 years old over 71), published in New England Journal of Medicine.
“We are satisfied with the interactions with regulatory authorities at the national and European level so far,” the company said in a statement. “We are committed to developing a safe and effective vaccine following the guidance of regulatory agencies and will continue our ongoing dialogue with the EMA.”
The vaccine is currently in the third testing phase, with 30,000 participants in the United States. According to the pharmaceutical company, its global production points to between 500 million and 1,000 million doses per year, starting in 2021. In addition to Europe, Canada is also studying the marketing of the Modern vaccine, according to reports on Tuesday. fair by the Reuters news agency.
Side effects similar to the flu vaccine
Previous studies have shown that age groups have responded positively to the vaccine and that rapid and strong immune responses against the new coronavirus have been induced. The side effects of the vaccine will be similar to those of the flu vaccine, says the The world.
Unlike other companies, Moderna has not yet had serious problems associated with its vaccine. The only known adverse cases associated with the vaccine are a volunteer with a high fever (39 degrees or more) and another developed fatigue to the point of suspending his daily activities, explains the Spanish newspaper. Side effects were resolved quickly.
On the other hand, the potential vaccine from AstraZeneca, developed in conjunction with the University of Oxford, had trials stopped in September due to an adverse reaction in a volunteer, who developed a neurological disease. The rehearsal was resumed a few days later. Johnson & Johnson also suspended clinical trials on vaccine Tuesday because one of the participants fell ill.
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