EMA begins rolling review of Sputnik V COVID-19 vaccine
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) at the European Medicines Agency (EMA) has begun a rolling review of the Sputnik V (Gam-COVID-Vac) COVID-19 vaccine.
Sputnik V is administered in two doses, each using a different adenoviral vector to deliver the gene encoding the SARS-CoV-2 Spike (S) protein – an extracellular protein on the virus which is used to bind to and enter human cells. The viral vectors cannot replicate or cause disease in humans, instead they deliver the genetic code to the vaccinee’s cells and prompts them to temporarily produce S proteins. This induces an immune response which primes the body against future infection by 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 boost the vaccine’s effect. The use of two different vectors is to prevent the development of antibodies targeting the adenoviruses from impacting on vaccine efficacy or causing adverse side effects. Sputnik V was developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology; however, the EU applicant for this medicine is R-Pharm Germany GmbH.
The decision to start the review was based on results from laboratory studies and clinical studies in adults which 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. Under the rolling review, the CHMP will review data as it becomes available, starting with the preclinical and early phase clinical data which is currently obtainable.
The committee will also assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality in the rolling review. EMA will continue to evaluate data until it decides enough evidence is available to support the submission of a formal marketing authorisation application.
According to the agency, because of the work undertaken during the rolling 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 the 39th country in the world, and second country in the EU, authorise Sputnik V for emergency use.
According to the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), the approval is based on the results of the clinical trials of Sputnik V in Russia a comprehensive assessment of the vaccine by experts in Slovakia. In trials Sputnik V was found to be 91.6 effective at preventing COVID-19 and provide full protection against severe cases of COVID-19.
The first shipment of the vaccine to Slovakia was delivered on 1 March 2021.
The vaccine is also approved in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of 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.