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EMA calculates that the first vaccines adapted to COVID-19 will arrive in September

The European Medicines Agency (EMA) assured this Thursday that the first vaccines adapted against SARS-CoV-2 variants, the virus that causes COVID-19could “potentially” be approved in September, and maintains its position of recommending the fourth dose only for those over 80 years of age.

In a virtual press conference, Marco Cavaleri, head of Vaccination Strategy at the EMAstressed that, in general, the epidemiological situation in the European Union (EU) “seems to be under control, and the number of infections and fatal cases of COVID-19 has decreased drastically”, due to advances in vaccination campaigns.

“We are considering the month of September as a potential moment for the approval of the first vaccines updated. Over the next few weeks, we anticipate making significant progress in this regard. The results of the clinical trial are expected to be available between June and August”, she celebrated.

In addition, he added that the increases in infections that have been seen in some European countries are cases of infections with the subvariants of Omicron known as BA4 and BA5, which “could become dominant” in the EU, but are “not associated with increased severity” of the disease.

“In the coming months we will need to carry out a follow-up of the epidemiological conditions in Europa to track the spread of all variants of concern (…) For now, we maintain our recommendation to administer a second booster dose, or a fourth dose, in people older than 80 years, “he added.

This strategy, he says, has been shown to work in protecting the most vulnerable, but he urged those who have not yet completed their primary vaccination or received their booster dose to be vaccinated, “in view of the possibility of another increase in the number of cases of COVID-19” after summer.

The EMA is evaluating the extension of the use of vaccine of Modern to children aged 6 months to 5 years, as well as the possible administration of a booster dose with the Pfizer (Comirnaty) preparation in children aged 5 to 11 years.

It is also evaluating the use of vaccine Nuvaxovid, from Novavax, as a booster dose in adults who have received both this and any other vaccine from the COVID-19 as a primary guideline.

Furthermore, experts from the EMA are analyzing the requests for a European license presented by Valneva and Sanofi-Pasteur for the community use of their vaccines.

EFE


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