Russia allowed to modify COVID-19 vaccines for new strains
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The government has extended the validity of drug registration certificates issued under the accelerated procedure in emergency situations or the fight against dangerous diseases until January 1, 2024. These drugs include, in particular, all Russian vaccines against coronavirus. In addition, Decree No. 441 has been amended to allow changing the composition of vaccines for the prevention of COVID-19. To do this, the manufacturer must submit to the Ministry of Health “a letter of guarantee on the conduct of a clinical trial in the period after the approval of the change regarding the new antigenic (strain) composition.”
This document was developed by the Ministry of Health in October 2022. The need for such amendments in the department was explained by the emergence of new variants of SARS-CoV-2 with multiple mutations in the S-protein, against which previously registered vaccines are no longer so effective. Thus, the developer of Sputnik V, the Gamaleya Center of the Ministry of Health of the Russian Federation, has already changed not only the composition of the drug, but also the form of release several times, without completing the entire cycle of clinical trials. On August 19, 2021, the Gamaleya Center announced that they had developed a version of the Sputnik V coronavirus vaccine modified specifically for the Delta strain. On November 29, 2021, the center began developing a modification of the vaccine for the new strain of coronavirus “omicron”. And in August 2022, the Ministry of Health told Kommersant that, in accordance with the updated instructions for medical use, the introduction of the Gam-COVID-Vac vaccine (trade name Sputnik V) is possible both intramuscularly and internally when using a nozzle – a sprayer on a vertical type syringe.
It should be noted that the world’s leading regulators (FDA, EMA, WHO) have also developed rules and recommendations for changing the strain composition of vaccines against COVID-19.
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