HomeMedicineEU postpones approval of Russian Sputnik V vaccine until next year

EU postpones approval of Russian Sputnik V vaccine until next year

The Sputnik V vaccine will not be approved by the European Union until the first quarter of 2022, as the vaccine must undergo additional checks.

According to Reuters, the EU medicines regulator, the European Medicines Agency (EMA), will not consider the Sputnik V vaccine as the Russian manufacturer has not yet provided the necessary data for a review scheduled for late November, SchengenVisaInfo.com reported.

What’s more, according to an unnamed Reuters source, the EMA said in an email that the Sputnik V vaccine should be considered in a rolling review until the agency receives a formal application for marketing authorization.

In addition, a Reuters source reported that EMA has asked the Russian manufacturer to complete the Sputnik V production dossier in full, including information such as active ingredients and final product filling.

“When they have this dossier, they will also be able to figure out where to go for an inspection,” the source said.

The EMA’s official website states that consideration of the Sputnik V vaccine began on March 4, 2021, along with the following vaccines:

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

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

EU Ambassador to Russia Markus Ederer holds Russia responsible for the fact that millions of people cannot visit the EU, as the country inhibits the mutual recognition of COVID-19 vaccination certificates.

According to Ederer, all the necessary documentation for mutual recognition has been transferred to the competent authorities, and the EU is ready to move forward on this issue. However, the Russian authorities do not share the same willingness as the EU authorities, given the fact that they have not yet prepared the documentation for submission to the European Commission in Brussels.

“I regret this because mutual recognition of equivalence, including by Russia, would definitely make life easier for people traveling in both directions,” Ederer said earlier to the Russian news site RBC.

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

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