The European Medicines Agency (EMA) decided this tuesday review the Chinese Sinovac vaccine, the main one used in Uruguay and applied in –at least– 22 countries around the world. Far from being a concern for the laboratory, the instance leaves the way free so that, as has already happened with other drugs, the European Union (EU) is on the way to validate it once the process is complete.
But what has to happen for it to be approved? What implications does this resolution have for vaccinated Uruguayans?
First, if the Sinovac vaccine is approved, EU countries will be able to start using it. For now only apply on a regular basis, by order of the Medicines Committee, injections of Pfizer/BioNTech, Moderna, Astrazeneca y Johnson & Johnson, and these last two are subject to age restrictions in the inoculated.
In order for the process to conclude with its approval, the body must closely monitor the previous results – which the laboratory has already made known in its clinical studies – and determine that it has sufficient information to guarantee its effectiveness. From then on, the company will be able to seal a formal application to launch into the market and obtain its emergency use license, such as the one it has had since February in China and Chile, Brazil, the Philippines, Ukraine and Turkey, among others.
In the previous one, the European agency indicated that the initial studies “suggest that the vaccine causes the production of antibodies that target SARS-CoV-2, virus that causes covid-19, and can help protect against the disease. “With these advances, according to the EMA,” it should take less time than normal to evaluate an eventual application (of the vaccine) as a result of the work carried out during ongoing review. “
On the other hand, in mid-March, the president of the European Commission, Ursula von der Leyen, advanced in the details of the delegation to implement a health passport, known as Green Digital Certificate of Vaccination, to make travel “safe” and help Member States to restore “freedom of movement”, which they intend to have ready by the end of June and thus face the boreal summer season. The bad news was, at the time, that the initiative was not going to contemplate Sinovac, the vaccine chosen by the Uruguayan government to immunize almost half of the country’s population. However, with the recent paradigm shift, the drug may be approved by the health authorities of the block just in time and benefit those vaccinated with the Chinese doses.
In case Sinovac is validated, Uruguayans who have received the injection from the laboratory and have their digital certificate will obtain facilities in circulation to, for example, enter certain sites. Otherwise, to travel to Europe they will need to present a negative PCR test, as is currently required of travelers.
The covid passport, still in process, “will be available, free of charge, in digital or paper format, and will include a barcode to guarantee the security and authenticity of the certificate “, announced the European Commission. In any of its formats, it will present information that shows that the carrier has already been vaccinated and that, therefore Therefore, it is immune to the coronavirus. It will be valid in all European countries and it will not only apply to EU citizens, but also to family members and persons authorized to enter.
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