Vaccination against a new koronavirusny infection began at rather fast speed, considering pandemic scales. At once several large producers provided the vaccines which are already allowed to clinical use. Despite it, the relation of a considerable part of broad masses to vaccination against COVID-19 remains reserved for the reason that the profile of safety of all used vaccines still is studied insufficiently carefully. It is connected as with still incomplete third phase of clinical tests, and with brief clinical experience of use of vaccines against a new koronavirusny infection.
Group of researchers conducted an observation research on safety of the vaccine Satellite V (Gam-Kovid-Vak) in the Republic of San Marino with use of active epidemiological surveillance.
In August, 2020 Satellite V was registered by the Russian Ministry of Health, and since December, 2020 it extends in 61 countries of the world. Satellite V, one of the first among vaccines COVID-19, is the heterological recombinant adenoviral vaccine with two various types of adenoviral vectors for the first and second dose developed by the National center of epidemiology and microbiology of Gamalei in Moscow. After registration, since December, 2020 began, mass distribution Satellite V in a number of the countries, including Argentina, Belarus, Hungary, Serbia and the United Arab Emirates. The list of the countries where satellite V was registered, since then considerably extended.
February 23, 2021 The republic of San Marino received the first delivery of Satellite V, having started a national campaign of vaccination of the 25th day of the same month, starting with health workers and the most vulnerable citizens. In 55 days after the beginning of vaccination of 46.1% of the population were vaccinated by the first dose Satellite V for the purpose of fast vaccination of all population.
In the course of planning of a national campaign of vaccination, it was extremely important to leaders of the Republic of San Marino to obtain the convincing evidence of efficiency and safety of vaccine. The only available research of the third phase of clinical tests of Satellite V showed to 91.6% immunological efficacy without the essential distinctions estimated in age layers and 100% efficiency against a medium-weight or heavy current of COVID-19. Grippopodobny diseases, reactions in the place of an injection, a headache and an asthenic syndrome were the most widespread by-effects after immunization. Any of serious side effects was not connected with vaccination.
The research objective consisted in describing the undesirable phenomena after immunization by the vaccine Satellite V by means of active epidemiological surveillance of the people who underwent vaccination in the country.
Since March 4 till April 8, 2021 the national research of the population of San Marino at the age of 18-89 which received one or two doses Satellite V was conducted. All people imparted Satellite V were actively interviewed by doctors right after vaccine injection. Criteria of the acceptability were defined as follows: age of ≥18 years, receiving at least one dose of vaccine. Criteria of an exception were defined as follows: inability it is correct to understand questionnaires or to respond to them. No randomization or special selection was made. All participants gave the informed consent to inclusion in the database for participation in a research. Distribution of the electronic questionnaire happened via e-mail, QR codes or telephone interviews approximately in 7 days after the first and second doses of vaccine. For quantitative assessment of frequency of side effects in both cases the descriptive analysis stratifying results on type and weight of symptoms was carried out.
By results of a research the following data were obtained. In general the frequency of side effects after the first dose was 53.3%. The people who received vaccine described both local, and system reactions in 16.4% of cases; besides, 25.8% of people reported about system reactions and 10.2% reported only about local symptoms. About a half of the participants of a research who answered questions filled out the questionnaire after the second dose of vaccine. In general, the frequency of PE was 66.8%; both local, and system reactions in 31.9% of cases were noted; in 18.5% of cases reported about system reactions and 16.1% reported only about local symptoms.
Thus, this preliminary analysis confirms higher or equal profile of tolerance of the vaccine Satellite V in an age group 60+ after both doses in comparison with other widespread vaccines COVID-19. Results of the discussed research will be coordinated with results of earlier carried out first and second phases of clinical tests.