EU postpones approval of Russian Sputnik V vaccine until next year

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The Sputnik V vaccine will not be approved by the European Union until 2022, as the vaccine needs to be further reviewed.

According to Reuters, the EU medicines regulator, the European Medicines Agency (EMA), will not review the Sputnik V vaccine because the Russian manufacturer has not yet provided the data needed for the planned review to take place by the end of November.

In addition, according to an anonymous Reuters source, the EMA said in an email that Sputnik V had not yet been examined in an ongoing review until the agency received a formal application for marketing authorization.

Furthermore, the Reuters source revealed that the EMA asked the Russian manufacturer to complete the application file for the production of Sputnik V, including information such as the active ingredients and the bottling of the final product. "When they have this file, they will be able to understand where to ask for inspections", said the source.

The official EMA website shows that the review of the Sputnik V vaccine began on March 4, 2021, along with the following vaccines:

  • The COVID-19 (Vero Cell) vaccine from Sinovac Life Sciences entered the review procedure on May 4.
  • NVX-CoV2373 from Novavax CZ AS submitted to the pediatric investigation plan on February 2
  • Vidprevtyn from Sanofi Pasteur entered the review on July 20.

On the other hand, the World Health Organization (WHO) has also submitted the Sputnik V vaccine under a separate review. The health organization announced that it will soon recognize the vaccine, because the problem that is in the way of its approval has been found and solved. The Russian Direct Investment Fund (RDIF), which is also the vaccine distributor, previously announced that a WHO delegation will soon visit Russia as a final approval procedure.

According to Ederer, all the necessary documentation on mutual recognition has been submitted to the competent authorities, and the EU is ready to go one step further. However, the Russian authorities do not share the same availability as those in the EU, given that they have not yet prepared the documentation to be submitted to the European Commission in Brussels.

"I regret this, because mutual recognition of equivalence, including by Russia, would certainly make life easier for people traveling in both directions."  previously stated Ederer for the RBC news site in Russia.

According to VisaGuide.World, about 73 countries have officially recognized the Sputnik V vaccine, such as the United Arab Emirates, San Marino, Northern Macedonia, Albania, Argentina, Armenia, Bahrain, Belarus, Bangladesh, Brazil, Hungary and India.

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