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EU regulator approves fifth Covid-19 vaccine

The European Medicines Agency (EMA) has recommended the use of a Covid-19 vaccine made by US-based biotech firm Novavax for people aged 18 and older. Trial data suggests the vaccine is 90% effective.

On Monday, the EMA backed the use of Nuvaxovid, a vaccine developed by Novavax, for adults, making it the fifth Covid shot to date to be given the green light by the bloc’s drugs regulator.  

“After a thorough evaluation, the EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine was robust and met the EU criteria for efficacy, safety and quality,” the agency said. 

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A research scientist works inside a laboratory of India's Serum Institute, the world's largest maker of vaccines, which is working on vaccines against the coronavirus disease (COVID-19) in Pune, India (FILE PHOTO) © REUTERS/Euan Rocha
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The EMA cited two large studies undertaken by the biotech firm in which the vaccine demonstrated efficacy of around 90% against strains of Covid-19 prevalent during the trials. The body admitted that there was limited data on some variants of concern, including Omicron.

The shot has been billed by some as an important development in overcoming vaccine hesitancy as Novavax’s jab is a protein vaccine which uses the same inoculation technology already used for decades against hepatitis, shingles, and other viral infections.

It requires two doses and is stable at refrigerated temperatures of between two and eight degrees Celsius. Data suggests only mild to moderate side effects are experienced by recipients.

The approval comes amid a sharp wave of new Covid-19 infections, driven by the Omicron variant. The vaccine had been undergoing a rolling review since February, and Novavax said it would start delivering to the EU in the first quarter of 2022.

It is expected that the UK will also approve the jab in the coming weeks. Novavax is yet to apply for approval in the US, where it has had to resolve manufacturing issues.

The firm’s share price jumped by more than 10% on Friday after the World Health Organization approved the shot made on license by the Serum Institute of India. 

source: RT




Împotriva articolelor redacției noastre, persoanele nemulțumite pot formula Contestație în termen de 10 zile de la publicarea articolului, la judecătoria Orășenească nr. 1 München Bayern Deutschland, in conformitate cu Legea federală Germană. Considerăm că nu se pot formula acțiuni la instanțele din România deoarece nici o persoană care activează în trustul nostru nu poate fi extrasă de sub jurisdicția federală germană. Considerăm că redacția noastră nu răspunde în fața autorităților din România ci doar celor federale sau civile germane. deoarece legea română nu are efecte de extraneitate asupra redacției chiar dacă subiectul știrilor face obiectul unor evenimente sau persoane din România și sunt scrise în limba română. Limba română nu este izvor de extraneitate a legii.

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Marius Leontiuc
absolvent WEB DESIGN Academia Britanică de Comunicare Iasi - absolvent COMUNICARE IN AFACERI Academia Britanica de Afaceri si Comunicare -absolvent JURNALISM EDITORIAL - London School University - 2019 inscris la echivalare diploma la Universitatea Politehnica Timisoara - absolvent studii de Drept Universitatea Europeană Drăgan, cursuri in Drept la Universitatea de Vest Timisoara, absolvent studii de proiectare, pastor coordonator in Biserica Protestanta Evanghelica, Android Developer pe Google Play și plugin developer la Oxwall, creator de teme Wordpress și Oxwall, operator Wordpress, Drupal, Oxwall, Osclass, Moodle, tehnologii HTML și PHP
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