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The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started an ongoing review of the Sputnik V (Gam-COVID-Vac) COVID-19 vaccine.
Sputnik V is given in two doses, each of which uses a different adenoviral vector to deliver the gene that encodes the SARS-CoV-2 Spike (S) protein, an extracellular protein from the virus that is used to bind to human cells. and enter them. Viral vectors cannot replicate or cause disease in humans, but instead deliver the genetic code to the cells of the vaccinated and induce them to temporarily produce S proteins. This induces an immune response that prepares the body against future infections from SARS-CoV-2, the virus that causes COVID-19.
Under the regimen, Ad26 is used in the first dose and Ad5 is used in the second to enhance the effect of the vaccine. The use of two different vectors is to prevent the development of antibodies directed against adenoviruses from affecting the efficacy of the vaccine or causing adverse side effects. Sputnik V was developed by the Gamaleya National Center for Epidemiology and Microbiology of Russia; however, the applicant for this medicine in the EU is R-Pharm Germany GmbH.
The decision to initiate the review was based on the results of laboratory studies and clinical studies in adults that indicated that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and therefore may help protect against COVID-19. As part of the ongoing review, the CHMP will review the data as they become available, starting with pre-clinical and early-phase clinical data that are currently available.
The committee will also assess Sputnik V’s compliance with customary EU standards for efficacy, safety and quality in ongoing review. The EMA will continue to evaluate the data until it decides that sufficient evidence is available to support the submission of a formal marketing authorization application.
According to the agency, due to the work done during the ongoing review, it should take less time than normal to evaluate an eventual application and make a decision.
Slovakia approves Sputnik V for emergency use
Slovakia has become 39th country of the world and second country of the EU, authorizes Sputnik V for emergency use.
According to Russia’s Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), the approval is based on the results of Sputnik V clinical trials in Russia, a comprehensive evaluation of the vaccine by experts in Slovakia. In trials, Sputnik V was found to be 91.6 effective in preventing COVID-19 and provides complete protection against severe cases of COVID-19.
The first shipment of the vaccine to Slovakia was delivered on March 1, 2021.
The vaccine is also approved in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, United Arab Emirates, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon, San Marino, Ghana, Syria, Kyrgyzstan, Guyana, Egypt, Honduras, Guatemala and Moldova.
