Moderna's Covid vaccine has been approved in the United States

Moderna's Covid vaccine has been approved in the United States

After the meeting of the FDA expert council, in which it was evaluated as highly protective and able to prevent the most serious cases from Covid-19, Moderna's anti-Covid vaccine officially receives approval for use in emergency in the USA

(Photo: Alexander Ryumin Tass via Getty Images) It has been defined as "safe and effective" and for this reason it has just been approved for emergency use by the US Food and Drug Administration (Fra), the which deals precisely with regulating drugs in the United States. This is the anti-Covid vaccine developed by the modern pharmaceutical company, the second to have received this authorization. We recall, in fact, that only a few days ago the FDA authorized the emergency use of another anti-Covid vaccine, the one developed by Pfizer-BioNTech. According to a recent review, released in recent days by the FDA, the data from clinical tests carried out by Moderna showed that two doses of the vaccine, administered one month apart, are "highly effective" in preventing Covid-19, at least at 14 days from receiving the second dose.

Two weeks after announcing that his vaccine is 94.1% effective (and up to 100% in preventing severe forms), on November 30, Moderna presented a requested for approval for emergency use of its vaccine from both the FDA and EMA, the European Medicines Agency. The vaccine, we recall, is based on messenger RNA, which has the task of encoding the genetic information that allows our cells (in particular ribosomes) to produce the coronavirus spike protein, the one that allows it to attach itself to target cells. Once in circulation, this protein activates and stimulates the immune system, leading the body to create neutralizing antibodies and T cells.

The clinical study presented by Moderna involved 30 thousand participants divided into two groups: the first received the double dose while the other received placebo. The final results showed that the cases of Covid-19 were 185 in the placebo group and only 11 in the one that received the double dose of the vaccine. The most common adverse reactions, on the other hand, were pain at the injection site (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), pain joint (44.8%) and chills (43.4%), while the most severe side effects occurred in 0.2% -9.7% of participants, and were more frequent after the second dose.

After the definitive go ahead for emergency use, according to forecasts by the New York Times, the distribution of about 6 million doses of Moderna's vaccine could start as early as next week, in addition to the millions of doses already shipped by Pfizer-BioNTech. The US government, in fact, signed agreements last summer with both Moderna and Pfizer to provide a total of 200 million doses in the first quarter of 2021. Since both vaccines require two administrations per person, therefore, the initial vaccination will be foreseen. for about 100 million people. Recently, according to the newspaper, the government announced that it had purchased another 100 million doses from Moderna for the second quarter, thus increasing the number of Americans who could be vaccinated to 150 million.

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