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the creators of “Sputnik V” demanded an apology from the EU regulator – RT in Russian



The creators of the Sputnik V vaccine have demanded a public apology from the head of the European Medicines Agency (EMA) Christa Virtumer-Hohe. The head of the regulator previously compared with the “Russian roulette” the possibility of issuing emergency approval for the use of a Russian drug in Austria. According to experts, such rhetoric undermines the credibility of the European agency and its expertise, and also raises concerns about possible political interference in this process. Sputnik V is currently undergoing the necessary checks for compliance with the “European criteria for quality and efficiency control.” The situation is developing against the backdrop of a wave of criticism that has risen within the EU related to the insufficient supply of vaccines already registered by the EMA.

The creators of the Sputnik V vaccine demanded an apology from the chairman of the European Medicines Agency (EMA) Christa Virtumer-Hohe, who compared the possibility of issuing an emergency permission to use the drug in Austria to a “Russian roulette”. They also stressed that vaccines, like the EMA’s actions, must remain out of politics.

“We demand a public apology from the head of the EMA Christa Virtumer-Hohe for her negative comments about the EU states directly endorsing Sputnik V. Her words raise serious concerns about possible political interference in the examination process currently being carried out by this agency, “Sputnik V said in a statement posted on Twitter.

It is noted that the European regulator did not allow such statements about any other vaccine, and such inappropriate comments “undermine the credibility of the EMA and its expertise.”

The experts added that the Russian drug has already been approved for use by 46 national regulators, and the EMA has no right to undermine the credibility of their decisions due to the fact that the procedure for its examination of Sputnik V was postponed for several months.

The indignation of the creators of the domestic drug was caused by the words of Virtumer-Hohe, who recently stated that she “strongly would not recommend” to authorize the emergency approval of Sputnik V in Austria (as Hungary and Slovakia had previously done) before the European regulator issued a permit.

In her opinion, the Russian drug can appear on the EU market after passing all the necessary checks and must comply with the “European criteria for quality and effectiveness control.”

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“In terms of effectiveness, safety and quality”: the EU regulator has started the examination of the vaccine “Sputnik V”

The European Medicines Agency has begun a consistent examination of the registration dossier of the Russian vaccine …

As a reminder, on March 4, the EMA began a rolling review of Sputnik V’s registration dossier. According to the press service of the Russian Direct Investment Fund, the decision was made taking into account the results of laboratory and clinical studies of the drug in adults.

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“We have provided EMA with all the necessary data on the vaccine, which has already been approved by more than 40 countries around the world. Sputnik V has the potential to make a critical contribution to saving millions of lives across Europe, and we look forward to reviewing the data by the Committee on Medicines for Medical Use. The vaccine partnership must take precedence over politics, and the partnership with EMA is an excellent example that confirms that only joining forces can defeat a pandemic. EMA approval will provide the Sputnik V vaccine to 50 million EU residents starting from June 2021, ”said Kirill Dmitriev, RDIF CEO.

The application for registration of the Russian vaccine in the European Union was submitted at the end of January, and on February 2, the authoritative medical journal The Lancet published the results of the third phase of the Sputnik V clinical trial, which confirmed its high efficacy and safety.

After that, the decision on the approval of the use of the drug at the national level was issued first by Hungary and then Slovakia. The desire to purchase the Russian vaccine was announced by the President of the Czech Republic Milos Zeman, according to whom the approval of the national regulator is enough to register the drug.

Last week, negotiations on Sputnik V were held with Austrian Chancellor Sebastian Kurz, who had previously called for an end to the “geopolitical struggle” in countering the coronavirus pandemic.

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The situation is developing against the backdrop of a recent wave of criticism related to the insufficient pace of providing the EU countries with already registered EMA vaccines (Pfizer / BioNTech, Moderna and AstraZeneca). This was indicated by Sebastian Kurz, Czech Prime Minister Andrei Babis, Hungarian Prime Minister Viktor Orban and other politicians.

It became known last week that the European Commission and the Italian government blocked the supply of a batch of 250 thousand doses of AstraZeneca vaccine intended for Australia, due to the fact that one of the pharmaceutical companies did not fulfill its obligations to the European Union.

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The Russian Sputnik V vaccine has already received approval for use in 46 countries with a total population of over 1.2 billion people. 7 …

Commenting on this step, the head of the European Commission, Ursula von der Leyen, did not rule out that new decisions could be made to block the supply of significant amounts of drugs outside the EU in order to ensure vaccination of the population within the association. According to her, AstraZeneca supplied less than 10% of the vaccine ordered by EU countries between December 2020 and March 2021.

In response, the Australian government announced its intention to create a coalition of countries to pressure the European Union on the supply of vaccines against coronavirus. According to ABC, this coalition may include Canada, Japan, Norway and New Zealand.

According to the World Health Organization, the number of confirmed cases of COVID-19 in the world has exceeded 116.5 million, of which a third – 40 million – are in the European region. Of the 2.56 million recorded deaths associated with the coronavirus, about 886 thousand (34.2%) are in Europe.

In Russia, over the past day, 9,445 cases of coronavirus were detected (at least since October 2), 9,931 people recovered, 336 died from complications. Most of the new episodes of COVID-19 were recorded in Moscow (1066), St. Petersburg (941) and the Moscow region (523).

In total, since the beginning of the pandemic, the diagnosis in the Russian Federation was confirmed in 4,342,474 people, of which 3,932,177 recovered, 89,809 died. 320,488 detected cases (7.38%) remain active.

According to Rospotrebnadzor, nearly 113.75 million coronavirus tests have been carried out in the country. About 518 thousand people remain under the control of doctors.





Source site russian.rt.com

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