A report published on Tuesday on the website of the Ministry of Health of the Russian Federation notes that there is still no certainty about the effectiveness of the vaccine approved by the Vladimir Putin government and that the contraindications, due to the lack of relevant studies, are numerous. In particular, the drug is contraindicated for those under 18, over 60, pregnant women, and people with a long list of underlying health conditions.
“Very common” adverse effects have been noted in its application, such as swelling, hyperthermia, lethargy, headaches, itching at the injection site, decreased appetite, diarrhea, and symptoms similar to those of a cold, according to the report. conducted by the Gamaleya Institute in Moscow, where the drug was developed, and also quoted by The Telegraph newspaper.
Although it is stated that most of these effects were “mild or moderate”, the document present in the vaccine registration certificate also clarifies that “it is not possible to determine with greater precision the incidence of adverse events due to the limited sample of participants in the study ”.
Russia declared on Tuesday to be the first country to approve a coronavirus vaccine, while Putin claimed that one of his daughters had been inoculated. By naming the vaccine Sputnik V (in honor of the first satellite launched into space, with the addition of the “v” for the vaccine), Russian officials assured that it provides safe and long-term immunity.
But documents from the Gamaleya Institute published on an official website of the Russian Ministry of Health insist that the vaccine had been tested in “a limited sample of participants”, in too short a time to conclude its effectiveness.
“Adverse events occurred frequently or very frequently,” says the report of the scientists who developed the Sputnik V vaccine. “It is not possible to define the occurrence of adverse events with greater precision due to the limited number of research participants” he adds.
The Institute noted that 38 volunteers participated in the trials for 42 days and 144 “adverse events” were recorded in the process, of which more than 30 were ongoing.
The report also cautions that the vaccine should not be given to those under the age of 18, over the age of 60, pregnant women, nursing mothers, or people with a variety of underlying health conditions. It adds that no investigation was conducted on how it might react with other drugs and the report makes clear that it is not known how long the protection would last despite claims by Russian officials that it would provide immunity for two years.
Specifically, the report warns about the application of the vaccine to people suffering from chronic liver and kidney diseases, diabetes, severe diseases of the hematopoietic system, epilepsy, strokes and other diseases of the central nervous system, diseases of the cardiovascular system, immunodeficiencies primary and secondary, autoimmune diseases, lung diseases, asthma and COPD in patients with diabetes and metabolic syndrome, with allergic reactions, atony, eczema.