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World 08/01/2021 The European Medicines Agency conditionally approves the use of the COVID-19 vaccine of Moderna
The European Medicines Agency conditionally approves the use of the COVID-19 vaccine of Moderna

Tashkent, Uzbekistan (UzDaily.com) – The European Medicines Agency has conditionally approved the use of the COVID-19 vaccine by the American company Moderna. 

The conditionality of the decision assumes that the developer will continue to provide the EMA with the results of the third phase of clinical trials, which will be conducted over the next two years.

To date, Moderna’s vaccine has been approved in the United States, Canada and Israel.

Currently, the decision of the European regulator EMA must be approved by the authorities of the European Union. According to the head of the European Commission, Ursula von der Leyen, the EC is in full swing working to quickly ensure access to this vaccine in the EU.

The Moderna vaccine was originally scheduled to be approved on 12 January. However, as experts note, the reduction in terms became possible as a result of the developer’s prompt provision of the necessary information to the regulator.

Under the framework contract, Moderna plans to deliver 160 million doses of vaccines in stages to 27 EU countries. According to the head of the German Ministry of Health J. Spahn, the distribution of the vaccine among the EU members depends on the population of each country.

At the same time, the official emphasizes that some EU countries do not want to receive the vaccine from this company.

II. The publication Tagesschau, citing the head of Moderna S. Bansel, reports that in January last year, after the PRC published the genetic sequence of the new coronavirus, the company’s scientists took only two days to develop the foundations of the vaccine. However, the vaccine from this company is the second approved in the EU.

On 21 December, the EU issued a permit for a vaccine developed by Pfizer and BioNTech. According to European experts, in the near future the EU also plans to approve vaccines from other developers, including the company AstraZeneca, whose preparations are already used in the UK.

According to the developers, both drugs are intended for people over 18 years of age and are highly effective (Pfizer - 95%, Moderna - 94.1%). Moreover, the latest vaccine, unlike its analogue from Pfizer, does not need ultra-cold storage.

At the same time, at the end of December, The New York Times reported the first case of an acute allergic reaction to the Moderna vaccine. Also, on January 5, at a WHO briefing, recommendations were presented on the use of Pfizer vaccine in connection with previously reported cases of anaphylactic shock in vaccinated individuals.

III. Despite the measures taken in the EU to vaccinate the population, experts note the ineffectiveness of the authorities in the speed of its organization.

For example, the Prime Minister of the Netherlands M. Rutte criticized members of the government because the country was the last in the EU to start vaccination of the population. According to him, the government has bet on the AstraZeneca vaccine, although it was clear a few months ago that Pfizer would be approved earlier.

There is also criticism of the German Minister of Health J. Spahn, accusing him of prolonged vaccination. On January 6, an emergency government meeting was held in Berlin to discuss a crisis plan to accelerate this process. However, due to the low rates of vaccine production, members of the government came to the conclusion that large-scale vaccination in Germany will begin no earlier than summer.

In order to speed up the vaccination process, the Serbian authorities decided to start inoculating the population of the country not only with the Pfizer vaccine, but also with the Russian drug Sputnik V. At present, the Russian Federation plans to supply 2 million doses to Serbia.

At the same time, Interior Minister N. Stefanovic and Speaker of the Serbian Parliament I. Dacic have already been vaccinated with the Russian vaccine.

In Albania, Bosnia and Herzegovina, Montenegro and North Macedonia, vaccination has not yet begun. It is reported that the foreign ministers of the Eastern European countries, as well as Sweden, Denmark and Finland, wrote a collective letter to the European Commission with a request to speed up the provision of vaccines, from which the proper reaction did not follow.

In general, as experts emphasize, the evolving situation around vaccination in European countries further weakens the already shaken confidence in the EU.

 

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