The European Medicines Agency (EMA) gave today green light the use of the vaccine from the pharmaceutical company Moderna against Covid-19 in the European Union (EU), the second approved by the European regulator.
In a statement, the European regulator indicates that it "recommended the granting of a conditional marketing authorization for the Covid-19 Moderna vaccine to prevent coronavirus 2019 disease in people aged 18 years and over."
This approval comes after the EMA Committee for Medicines for Human Use (CHMP) has "exhaustively evaluated data on the quality, safety and efficacy of the vaccine and recommended by consensus the granting of a conditional formal marketing authorization by the European Commission" , said the community regulator in the press release.
Moderna's vaccine, with a proven efficacy of over 90%, is the second to be endorsed by the EMA, after the approval, on December 21, 2020, of the drug developed by pharmaceutical companies Pfizer and BioNTech, which is being used in the space. European since 27 December.
EMA executive director Emer Cooke says, cited in the statement, that Moderna's vaccine is yet "another instrument to overcome the current emergency" generated by the Covid-19 pandemic.
"It is proof of the efforts and commitment of all involved to have this second positive vaccine recommendation, just one year since the pandemic was declared by the WHO," said the official.
A large clinical trial promoted by Moderna, involving 30 people, revealed that the vaccine from this North American pharmaceutical company was effective in preventing Covid-19 in people over 18 years of age, with an overall efficacy of 94,1% and 90,9 .XNUMX% in severe cases.
Like Pfizer and BioNTech's vaccine, Moderna's is given by two injections in the arm separated in time, in this case 28 days apart.
And like other vaccines, this one from Modern to Covid-19 has mild side effects such as pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle pain and joints, nausea and vomiting.
EMA said in the statement that "the safety and efficacy of the vaccine will continue to be monitored as it is used across the EU, through the pharmacovigilance system and additional studies carried out by the company and European authorities."
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