The official representative of the World Health Organization (WHO) Margaret Harris told RT that the organization is still checking the technical dossier on the Russian Sputnik V coronavirus vaccine. The drug has not yet been approved by either the WHO or the EU, while at WHO this process has been dragging on for more than a year. The organization itself explained that there are questions to one of the Russian factories where the vaccine is produced, and that Russia did not provide all the necessary information. Margaret Harris said WHO expects more data from Russia regarding the vaccine.

“We are still evaluating the technical dossier for the Sputnik V vaccine and are awaiting more information. The process continues, ”she said.

The WHO spokesperson asked to abandon the notion that the organization only approves of Western vaccines, that is, British, European or American. She noted that WHO has also already licensed vaccines from China and India.

To date, WHO has registered seven vaccines against COVID-19 - the American Pfizer / BioNTech, Moderna and Janssen, the British-Swedish AstraZeneca, the Chinese Sinopharm, CoronaVac and the Indian Covaxin. Five more, including Sputnik V, are undergoing certification.

"For some vaccines, including those from what is called the traditional West, this [approval] process takes a long time," Harris explained.

What the WHO said about the approval of Sputnik V

The Sputnik V vaccine was registered in Russia in August 2020. It became the world's first officially registered vaccine. At the end of October of the same year, the Russian Direct Investment Fund (RDIF, which represents the vaccine abroad), filed an application with WHO for accelerated registration of the drug. In May of this year, WHO said it still had not received a complete vaccine dossier. The organization promised that as soon as it appears, experts will test the safety of the vaccine. To do this, they must evaluate how the clinical trials have been conducted and verify production. Problems arose with the latter.

In June, WHO announced that it had checked four Russian plants where the vaccine was produced, and there were comments about the work of one of them, in Ufa. The plant identified problems with sterility assurance and with the traceability and identification of vaccine batches.

In September, due to the results of the inspection, WHO suspended the approval process for Sputnik V. At the end of October, the process was resumed.

The organization has promised that the drug approval process is in its final stages. However, the inspectors will have to visit Russia again to check everything and complete the necessary documents. WHO announced that they will not arrive in the country until January next year.

What Russia Says

The Ministry of Health and Roszdravnadzor, in response to the WHO audit, assured that multilevel control excludes the ingress of low-quality drugs to the consumer. The press secretary of the Russian President Dmitry Peskov said that the plant has corrected the found deficiencies.

In early December, the head of RDIF, Kirill Dmitriev, said that WHO was delaying the recognition of Sputnik V due to bureaucratic delays.

“The Russian Ministry of Health maintains close ties with the WHO, and we understand that there are still minor obstacles in our path, but they are exclusively bureaucratic in nature,” he said.

According to Dmitriev, there are no real reasons for the delay in the approval of the drug, since its efficacy and safety have been confirmed by clinical studies and experience of use.

Later in December, Peskov admitted that Russia has not yet provided WHO with all the information it needs to certify the vaccine.

“We had a different understanding of exactly what information should be and how it should be provided,” he explained.

Head of the Center. NF Gamalei, who developed the vaccine, Alexander Gunzburg said that the West does not want to recognize Russian vaccines, because their competitors are not profitable for their appearance on the international market.

“The turnover of this drug is probably higher than, or equal to, the turnover of all others on planet Earth for obvious reasons. And the main difficulty is who will get the dividends from the use of several vaccine preparations that are currently being used, ”he said.

Where Sputnik V has already been recognized

According to the website, the Russian vaccine has already been approved in 71 countries with a total population of 4 billion people. However, without the approval of the WHO and the European regulator, those who were vaccinated with the Russian drug are officially considered unvaccinated in the EU. They cannot receive a European vaccination certificate, which means they cannot travel freely to any country or avoid a number of restrictions imposed in Europe against the spread of coronavirus.

Italy and Austria made some concessions in November. They allowed those who received the Sputnik V vaccine and received one injection of Biontech / Pfizer or Moderna to receive a vaccination certificate.In addition, a number of EU countries, without waiting for the decision of the general regulator, decided to recognize the certificates of those who were vaccinated with "Sputnik V". With a domestic vaccination certificate, Russians can go to countries such as Hungary, Croatia, Bulgaria, Greece, Slovenia, Cyprus, and also to the Portuguese island of Madeira.

Deputy Prime Minister Tatyana Golikova announced on December 13 that Russians vaccinated abroad with foreign vaccines will be able to receive a vaccination certificate in Russia. “They will be able, having arrived or being in Russia, to pass an analysis for antibodies. In the presence of antibodies, they will be issued an appropriate document for a period of six months, ”explained Golikova.

She added that Russia is also negotiating with the EU on the mutual recognition of certificates. If they are successful, foreign certificates will be applied in the Russian Federation along with Russian ones.

Peskov separately clarified that this does not mean that Russia is in a hurry to recognize foreign vaccines. “This is more a recognition of the presence of antibodies, not a recognition of Western vaccines. Although work in this direction also continues, ”he said.

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