Europe begins to assess Coronavac approval – 05/05/2021 – Worldwide

The European regulatory agency (EMA) began on Tuesday (4) to analyze Coronavac, a vaccine developed by the Chinese Sinovac, also produced and used in Brazil.

The vaccinator has entered a continuous review process, the goal of which is to expedite the evaluation of a promising drug during public health emergencies.

According to the EMA’s Human Medicines Committee, preliminary results from laboratory studies and clinical trials justify opening the process.

The Sinovac vaccine is not applied today in any European country – Hungary and Poland apply that of the Chinese Sinopharm, still without analysis of the EMA.

A future approval of Coronavac could however open the doors of the continent to tourists having taken the two doses of the immunizer and not coming from countries with variants considered worrying, according to the reopening plan announced Monday by the European. Union.

At the moment, non-essential travel is only allowed for those arriving from seven countries with a maximum of 25 new cases of Covid-19 per 100,000 inhabitants in 14 days. The EU wants to expand the list to those with up to 100 new cases / 100,000 and release travelers who, at least 14 days before arrival, were fully vaccinated with an EMA-approved vaccine.

There is also the possibility of accepting those authorized by the WHO (World Health Organization), where the amendment to Coronavac should take place this week, according to the director of the regulatory area of ​​the entity, Mariângela Simão.

In an interview on Monday, she said a decision should be made by Friday for Sinovac and Sinopharm / Beijing products.

Both manufacturers use the inactivated (dead) Sars-Cov-2 virus, which when inoculated is identified by the body as a foreign body and triggers the production of defense cells. If the vaccinated individual is infected with the living coronavirus, the immune system is ready to recognize it and defend itself against it.

A proven vaccination should be one of the criteria for opening Europe up to tourists, but the European Commission (EU executive) and national governments may impose further restrictions, such as tests and quarantines.

The bloc is already planning an “emergency brake” to limit the entry of travelers from countries with a high incidence of variants considered to be of concern – such as Brazil.

The Brazilian infection rate is also four times higher than the new maximum limit proposed for “green zones”: there are 400 new cases per 100,000 inhabitants in 14 days, according to the latest data from the ECDC (European Center for disease control). More than 400,000 Brazilians have died from Covid-19 since the start of the pandemic.

The new travel rules proposed by the Commission are starting to be analyzed this week by the European Council, which brings together the governments of the 27 member countries.

Once approved, they will apply to the Schengen Free Internal Transit Zone, which includes the EU – except Ireland -, Norway, Iceland, Switzerland and Liechtenstein.

The latest information on the rules applicable to people coming from outside the bloc can be found on the Re-open UE website.

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