Moderna Vaccine approved

By TPN/Lusa, in News · 06-01-2021 17:22:00 · 0 Comments

The European Medicines Agency (EMA) today gave the "green light" for the use of the Moderna Pharmaceutical vaccine against Covid-19 in the European Union (EU), the second approved by the European regulator.

In a press release, the European regulator said it "recommended granting conditional marketing authorisation for the Covid-19 Moderna vaccine to prevent the coronavirus disease in people aged 18 and over".

This approval comes after the Human Medicines Committee of the EMA (CHMP) "thoroughly evaluated the data on the quality, safety and efficacy of the vaccine and recommended by consensus that a formal conditional marketing authorisation be granted by the European Commission", the EU regulator said in a press release.

The Moderna vaccine, with a proven efficacy of more than 90 percent, is the second to be endorsed by the EMA, following the approval on 21 December 2020 of the drug developed by pharmacists Pfizer and BioNTech, which has been in use in Europe since 27 December.

A large modern clinical trial involving 30,000 people revealed that this US pharmacist's vaccine was effective in preventing Covid-19 in people over 18 years of age, with an overall efficacy of 94.1 percent and 90.9 percent in severe cases.

Like the Pfizer and BioNTech vaccines, the Moderna one is administered by two injections in the arm separated in time, in this case 28 days apart.

And like other vaccines, Moderna's has mild side effects such as pain and swelling at the injection site, tiredness, chills, fever, swollen or sensitive lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting.

The MPE states in the press release that "the safety and efficacy of the vaccine will continue to be monitored as it is used throughout the EU, through the pharmacovigilance system and additional studies by the company and European authorities".



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