In Russia, the production of a vaccine against coronavirus, developed by the National Research Center for Epidemiology and Microbiology (NITsEM) named after N.F. Gamalei. This was reported by the press service of the RF Ministry of Health.
“The production of a vaccine against the new coronavirus infection COVID-19, developed by the N.N. Gamalei of the Ministry of Health of Russia, ”the message says.
The ministry clarified that the first batch of the vaccine has already been produced.
Recall that the drug, named "Sputnik V" in honor of the first artificial satellite of the Earth, is a solution for intramuscular injection.
According to the director of the Gamaleya Center, Alexander Gintsburg, the release period for the required amount of the drug for Russians may take from nine to 12 months.
“It is important to understand when we will more or less have time to cover the country's needs. I hope within 9-12 months, ”the specialist said.
He also said that in the third phase of vaccine trials, volunteers will participate on an outpatient basis.
“Of course, the volunteers will not be hospitalized beforehand. Everyone will come from home and go home, ”explained Gunzburg.
The specialist clarified that on the first day of testing, blood will be taken from volunteers to compare the level of increase in antibodies. The next blood sample will be taken three weeks after the first vaccination. For the third time, tests will be taken 21 days after the second vaccination.
Gunzburg added that there is no final protocol for post-registration studies yet, but suggested that these tests will be easier than the previous stages.
Earlier in an interview with RT, Alexander Gintsburg said that the development of the Russian vaccine against COVID-19 was carried out strictly in accordance with Russian law, and no side effects were detected in volunteers during the tests.
“This drug was created in accordance with the 441st decree, which can significantly reduce the time to create the drug. Moreover, in no way reducing the number of those control research procedures that are aimed at proving the safety of this drug, ”the specialist emphasized.
He explained that this decree makes it possible to conduct a number of studies in parallel, but does not cancel any of them.
“Therefore, on the one hand, this (purely regulatory) fact made it possible to reduce the time required to create this drug. And at the same time, as I have already said many times, the vaccine was not created from scratch, ”the scientist explained.
He stressed that the staff of the institute have been working for more than 20 years to create the technology with which this vaccine was created. Experts used the developments obtained during the creation of a vaccine against the Ebola virus, as well as against the Middle East respiratory syndrome coronavirus MERS. According to him, the experience that was used to create that vaccine was in many ways “transferred like a matrix” when creating a drug for COVID-19.
Gunzburg clarified that we are talking, among other things, about the doses of immunization for animals and humans. This, the head of the center emphasized, explains the creation of a vaccine in such a short time. As the scientist emphasized, the specialists had "the entire methodological apparatus" at hand.
“In total, to date, more than 3.5 thousand residents have received this vaccine preparation without any side effects - with the exception of those that usually occur with any vaccination. Namely: a slight rise in temperature, which is removed (as in the instructions - if you look at when it will be publicly available) just a pill of paracetamol, ”he said.
In addition, the scientist noted that the protective properties of the Russian vaccine against coronavirus will persist for at least two years after its introduction.
In turn, the head of the Ministry of Health Mikhail Murashko spoke about the high demand for the Russian vaccine abroad, stressing that Russia has not yet sold the drug.
“First of all, we now need to develop vaccines for the domestic market,” he said, explaining that the drug must first of all be provided to those who work with COVID-19 patients and people from risk groups.
The fact that Russia was the first in the world to register a vaccine against coronavirus was announced on August 11 by President Vladimir Putin. The head of state said that the vaccine is made on the basis of adenovirus vectors and forms a stable antibody and cellular immunity. He also stated that one of his daughters had already been vaccinated.
“After the first injection, after the first vaccination, she had a temperature of 38, the next day - 37 with a little and that's it. After the second injection, the second vaccination, the temperature also rose a little, but then subsided. He feels good - and the credits are high, ”the Russian leader explained.
Putin also expressed the hope that the work on the creation of vaccines will continue with colleagues abroad, after which there will be enough drugs on the world market that can be used.