When will WHO approve the Sputnik V vaccine?

When the Sputnik V vaccine appeared in Belarus

The first batch of the Russian's COVID-19 vaccine arrived in Belarus on December 29, 2020. The next day, the beginning of vaccination of the population was announced. In March 2021, Belarus began to produce Sputnik V independently. Now it is produced at the Belmedpreparaty enterprise and is used for vaccination in Belarus.

Efficacy of the Sputnik V vaccine

According to the results of the analysis of data on the incidence of coronavirus among Russians vaccinated with both components of the drug in the period from December 5, 2020 to March 31, 2021, the effectiveness of the vaccine is 97.6%.

The results of the third phase of clinical trials in Russia were published in the Lancet journal on February 2, 2021. According to the research published in the journal Vaccines, Sputnik V is effective against Alpha B.1.1.7, Beta B.1.351, Gamma P.1, Delta B.1.617.2 and B.1.617.3, B.1.1.141 and B.1.1.317 strains.

The decrease in the viral neutralizing activity of Sputnik V against the omicron strain is 3-7 times less, compared to the indicators of other leading vaccines.

When the Sputnik Light vaccine appeared in Belarus

The first batch of the Sputnik Light vaccine arrived in Belarus on September 3, 2021. The Sputnik Light vaccine is one-staged, it is intended for revaccination, as well as vaccination of patients after COVID-19 and young people under 23 years of age.

Revaccination with Sputnik Light after Sputnik V

Sputnik Light is the first component of the Sputnik V vaccine. This single-component vaccine is suitable for revaccination after Sputnik V or other vaccines.

The Ministry of Health of Belarus advises to do booster vaccination (the second dose) with Sputnik Light only 6 months after the first dose of Sputnik V or another vaccine. Revaccination should be carried out after 12 months or more.

When WHO made first attempts to approve Sputnik V

World Health Organization began the approval process of the Sputnik V vaccine at the end of May 2021. The inspection was carried out together with the European Medicines Agency and ended on June 13.

However, on June 26, WHO prequalification department found violations in the production of the vaccine. Most of the identified problems were related to sterility and environmental protection. The approval of the vaccine by EMA was also delayed due to missing the deadline for submitting clinical trial data.

When approval of Sputnik V was suspended

The approval process of Sputnik V was suspended in September 2021 until a new inspection of the manufacturer's plant in Ufa, where non-compliance with GMP standards was found.

The claims were related to microbiological monitoring of production and the environment, as well as traceability and identification of vaccine batches. Also problems were identified with filling lines and clothing of those who perform sterile procedures, as well as with confirming the required level of sterilizing filtration of the vaccine were found at the plant

The report emphasized that these claims do not apply to other Sputnik V manufacturers.

News about the approval of Sputnik V by WHO: chronology

With the first inspection, WHO arrived in Russia in June 2021. At the end of the month, inconsistencies in vaccine production standards were found.

The break in the work on the approval of the vaccine lasted from September to November 2021. In November, WHO held a meeting with representatives of the Russian Direct Investment Fund. WHO reported that they need additional data on the quality, safety and effectiveness of the Russian vaccine.

In the interview on December 28, 2021, WHO representative Margaret Harris said that data on the safety and effectiveness of Sputnik V were being analyzed. The documentation on the production technology was also being checked.

Also at the end of December 2021, the WHO said that the inspection plans to visit Russia in February 2022.

Information on the recognition of the Sputnik V vaccine on January 24, 2022

On Friday, January 21, the press secretary of the President of the Russian Federation announced that the transfer of all documents that the WHO lacked for the recognition of Sputnik V had been completed.

Russia expects a WHO inspection in February 2022.

Photo: ria.ru