The Gamaleya National Research Center for Epidemiology and Microbiology has updated the instructions for its Sputnik V vaccine; now the effectiveness of the drug is stated as 70.5%. The changes were made on January 31, 2022. The document is posted in the State Register of Medicines, where it attracted PhV’s attention.
In the previous version of the instruction, the effectiveness indicator was 91% based on data from an interim analysis of clinical trials, whereas the current data are based on clinical trials. A new item was added to the description of effectiveness: “significantly reduces the severity of the disease.”
The updated instruction confers the same status to the first component of the Sputnik V as to Sputnik Lite.
According to the instruction, a single vaccination with component I is allowed if necessary. It is stated that the ise of only one component is not recommented for people over 60 years of age who have not previously had COVID-19 and have not been vaccinated, as well as for immunocompromised patients.
The new instruction includes data on the average titer of antibodies in volunteers after immunization. Six months after the introduction of the vaccine, it was 1,708, down from 9009 on day 42. The volunteers who received a placebo had a significantly low level of the indicator, of 110.2, after six months. However, the average antibody titer after placebo administration increased when evaluated on day 42 and six months later.
