ROME, OCTOBER 14 (ANSA) – The candidate vaccine against the new coronavirus mRNA-1273, developed by the North American pharmaceutical company Moderna, was considered “suitable” to apply for registration with the European Medicines Agency (EMA) and the consequent distribution in the territory European, the company said on Wednesday (14).
According to the note distributed to the press, the application procedure will start “in the next few days”, being the third of its kind to arrive at the European agency. Before the modern immunization, ChAdOx1 n-CoV, from the University of Oxford and the pharmaceutical AstraZeneca, and BNT 162b, from the German BioNTech and the pharmaceutical Pfizer, also started the approval process.
The approval of the “suitability” of the vaccine allows proponents to submit an application even before the completion of clinical tests and conclusive results, which, in the case of Covid-19, is being adopted to speed up the immunization process.
EMA experts will therefore analyze the results of pre-clinical and phase 1 and 2 clinical tests (out of 3 in total) performed on healthy people aged 18 to 55 and on elderly people and published in the “New England Journal of Medicine “.
Currently, the vaccine against Sars-CoV-2 from Moderna is in phase 3, which includes 28,618 participants, and more than 22,000 of them have already received the second dose of immunization.
In the statement, the North American company also informed that it works with two European brands – the Swiss Lonza and the Spanish Rovi – for the production and packaging of the vaccine.
“We are committed to developing a safe and effective vaccine on the advice of regulatory agencies and will continue our ongoing dialogue with EMA. Moderna is increasing its global production capacity to be able to deliver 500 million doses per year and possibly , from 2021, up to one billion doses a year “, stated the company’s CEO, Stéphane Bancel.
MRNA-1273 is one of the most promising vaccines against Covid-19 and has shown positive results in its early stages. Immunization is developed in partnership with the National Institute of Allergies and Infectious Diseases (NIAID), led by infectious disease Anthony Fauci, the main epidemiological member of the US government’s task force against the pandemic.
The vaccine is made from Sars-CoV-2 RNA, using one of the most advanced technologies available. The purchase of 80 million doses of mRNA-1273 by the European Union is being negotiated with the European Commission. (ANSA).
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