The European regulator discovered a lack of data on Sputnik V

The delay in the approval of the Russian Sputnik V vaccine by the European regulator EMA is due to numerous gaps in the data provided by the Russian side, writes Reuters. Among them there are a number of "serious", but not "critical".

Last month, Reuters wrote that another delay was caused by the failure of the Russian side to provide data from clinical trials by the June 10 deadline. In the current article, the agency argues that the problems run deeper.

• According to a source close to the EMA, the missing information includes standard forms about side effects in clinical trials. In addition, it is not clear how the scientists tracked the health status of the participants who received the placebo.

• Separately, a French delegation of scientists studying Sputnik V at the end of 2020 found that there was no EU-compliant documentation for the cell bank on which the vaccine was based. Such documentation allows to verify the absence of bank contamination. This vaccine is created on the basis of a cow cell culture, which can theoretically contain dangerous proteins - prions, and the delegation did not receive guarantees from the Russian Institute of the purity of the origin of the culture, writes Reuters. This conclusion has been brought to the attention of the EMA.

• In addition, the agency writes that the Russian side only after persistent requests from the Brazilian regulator was able to guarantee that the adenovirus in the vaccine is incapable of reproduction. The carrier of the coronavirus fragments in Sputnik V are two strains of adenovirus, and the documentation originally provided contained information about their possible reproduction, Brazilian regulator Anvisa told Reuters. Now in Brazil, Sputnik V is approved only conditionally; mass vaccination has not begun with it.

• Several people who worked directly with the Institute. Gamaleya, believe that the constant problems with the completeness of information are associated with the lack of experience of the institute with international regulators. "They're not used to working with structures like EMAs," says one of them.

• One source close to the approval process says there is no reason to doubt the effectiveness of the Russian vaccine itself. However, fixing "serious" documentation problems takes time and effort, so Sputnik V's approval before the fall is unlikely.

What they say in Russia

RDIF, which oversees Russian vaccines, called the Reuters claims “false and incorrect,” and the agency’s sources deliberately harmed the reputation of Sputnik V as part of an information attack by the “Western pharmaceutical lobby.” RDIF claims that the basic cell bank is “fully compliant with EMA requirements,” and this has been independently confirmed (by whom, it is not reported, Reuters notes). And adenovirus is incapable of reproducing in all batches of the vaccine released.

Last week, Putin's spokesman Dmitry Peskov expressed confidence that the Russian vaccine would be recognized in Europe "if any prejudice is set aside - be it of a political nature, of an artificial nature, of a lobbying nature." Before that, Secretary of State at the French Foreign Ministry Clement Bon warned EU countries against using Russian (and Chinese) vaccines without the approval of a pan-European regulator.

Today, the head of the RDIF, Kirill Dmitriev , said that he expects Sputnik to be approved in the fall, but through the WHO, not the EMA. In accordance with current European legislation, this will also open the way to Europe without quarantines and tests with the vaccinated Russian vaccine.