Yesterday in Russia, the first vaccine against coronavirus Sputnik V, or Gam-Covid-Vac, was registered. President Putin said that it works quite effectively and forms a stable immunity. The head of state also added that one of his daughters had already been vaccinated. Health Minister Mikhail Murashko added that according to the results of research, the vaccine has shown high efficiency and safety. All volunteers developed high titers of COVID-19 antibodies. At the same time, none of them had serious complications of immunization. However, after studying a non-public report from the Gamaleya Center, in which the vaccine was created, it turned out that a total of 144 side effects were recorded in 38 healthy adult volunteers, some of which are still observed.
The report of the Gamaleya Center indicates that the drug has passed the registration procedure, which is used in the event of an emergency. Such a vaccine can only be used in medical institutions that are eligible for such procedures.
In addition, it remains unknown how long the immunity to the new type of coronavirus will remain – the studies were not extensive enough and were carried out in a short time.
The protective titer is currently unknown. The duration of the protection is unknown. Clinical studies to study the epidemiological effectiveness have not been conducted.
excerpt from the documents of the Gamaleya Center
The titer is the limiting dilution of a blood serum sample, at which the activity of antibodies is detected.
42 days after vaccination, the antibodies to the virus with an average titer of 49.3 were recorded in the blood of the volunteers. Fontanka notes that this value is even lower than the average level of antibodies, and over time it may decrease.
However, the Ministry of Health claims that the vaccine is able to form a stable immunity – at least it should last for about two years. Professor of Pathophysiology at the First Moscow State Medical University. Sechenov, Anton Ershov noted that there is no confirmation of this.
Also from the report of the Gamaleya Center, it turned out that side effects in vaccinated people are “often or very often.” However, it is not possible to determine more precisely the incidence of adverse events due to the limited sample of study participants.
A total of 144 side effects were observed in 38 volunteers, but most of them did not have serious consequences. Yet, 42 days after vaccination, 31 symptoms persisted. It is noted that they were mainly associated with deviations in the parameters of the immune system. The Gamaleya Center document states that the outcome of 27 events is still unclear.
In particular, the volunteers who received the vaccine complained of fever, headache, diarrhea, asthenia, malaise, pyrexia, nasal congestion, sore throat, and rhinorrhea. Swelling, pain, pyrexia, and itching were noted at the site of inoculation.
The vaccine cannot be administered to pensioners, children, and pregnant women – no studies have been carried out on them.