Deputy head of the Gamaleya Center spoke about the process of registering the Sputnik V vaccine with the EMA and WHO

“There are two parts, EMA and WHO.

There is a part with the evaluation of clinical trials, there was an EMA inspection, which evaluated the protocol of clinical trials, its correctness.

We accordingly received a positive conclusion without critical remarks.

Therefore, we have passed this part,” he said.

According to him, the most difficult is the second part - production.

“The second part is the production part.

This is the most energetically difficult moment of harmonization, because it is a matter of harmonizing production regulations and not even regulations, but production standards.

It is actually the most difficult and at the moment we are in the process of this coordination - first of all, our production sites, which volunteered to be certified according to WHO and EMA standards, ”he said.

Earlier, Russian Foreign Minister Sergei Lavrov said that Russia is working with WHO and EMA to certify the Russian vaccine.