The Sputnik V vaccine will not be approved by the European Union until the first quarter of 2022, when the vaccine needs to undergo additional reviews.
According to Reuters, the European Medicines Agency (EMA), the European Union’s drug regulator, will not review the Sputnik V vaccine because the Russian manufacturer has not yet provided the data required for the review, scheduled for the end of November, according to SchengenVisaInfo. com reports.
Moreover, according to an unnamed source from Reuters, the EMA said in an email that Sputnik V has not yet been vetted under a rolling review until the agency receives an official marketing authorization application.
Moreover, a Reuters source revealed that EMA has asked the Russian manufacturer to complete the entire application file for the production of the Sputnik V, including information such as active ingredients and the packaging of the final product.
“When they have that file, they will also be able to understand where to order the inspections,” the source said.
The official website of the EMA shows that the review of the Sputnik V. vaccine began on March 4, 2021, along with the following vaccines:
The COVID-19 vaccine (Vero Cell) from Sinovac Life Sciences entered the review procedure on May 4. NVX-CoV2373 from Novavax CZ AS was submitted to the Pediatric Investigation Plan February 2 Vidprevtyn by Sanofi Pasteur entered review on July 20.
On the other hand, the World Health Organization (WHO) has also put the Sputnik V vaccine under separate review. The WHO has announced that it will learn about the vaccine soon as the problem standing in the way of its approval has been found and addressed. The Russian Direct Investment Fund (RDIF), which is also the distributor of vaccines, earlier announced that a WHO delegation would visit Russia soon as a final approval procedure.
TheSchengen.com previously reported that the European Union’s ambassador to Russia, Markus Eder, sees Russia as responsible for millions of people who have been unable to visit the European Union because the country stops mutual recognition of certificates of COVID-19 vaccination.
According to Ederer, all the necessary documents related to mutual recognition have been submitted to the relevant authorities, and the European Union is ready to take this matter a step further. However, the Russian authorities do not share the same desire with those in the European Union, given the fact that they have not yet prepared the documents for submission to the European Commission in Brussels.
“I’m sorry about that because mutual recognition of parity, including by Russia, will definitely make life easier for people who travel in both directions,” Idir told Russian news site RBC previously.
According to VisaGuide.World, about 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.