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On 17 February, the European Commission launched its “HERA Incubator” to address the threat of new coronavirus variants. HERA will work with researchers, biotech companies, manufacturers and public authorities to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities.
Asked about the status of Sputnik V, European Commission President Ursula von der Leyen raised three issues: authorisation, production site verification, and a question over how Russia could “theoretically” offer millions and millions of doses, “while not sufficiently progressing in vaccinating the own people. This is also a question I think that should be answered.”
Authorization
Von der Leyen confirmed that the Sputnik V vaccine developers had not applied for conditional market authorization with the European Medicines Agency (EMA), despite reports to the contrary, but added that that might change.
Sputnik like all vaccine candidates will have to follow the EU’s full scrutiny process. The EMA has already published a clarification (10 February) because of misleading press reports claiming that Sputnik V had made an application for a rolling review, or market authorisation for their vaccine, it hasn’t.
Today, the EMA sent a tweet making it clear, again, that the Sputnik vaccine was not under “rolling review” or the later “market authorisation” process.
Instead, the EMA has confirmed that the developers have received scientific advice on the latest regulatory and scientific guidance for the development of their vaccine, those companies that have received advice are listed on the EMA website.
Nevertheless, yesterday, Sputnik V claimed yet again in a Twitter response to von der Leyen: “Sputnik V submitted an application for rolling review, request for market authorization is the next step.”
According to Statista, a company specializing in market data, over 200 million doses have been agreed for export to 20 countries, and there are major plans for production outside Russia in Korea, India, Brazil, Saudi Arabia, Turkey and China, according to the Sputnik website. As of February 2021, vaccination with Sputnik V has started or is starting in the following countries: Bolivia, Algeria, Kazakhstan, Turkmenistan, Palestine, the UAE, Paraguay, Hungary, Armenia, Bosnian Serb Republic, Venezuela and Iran.
The widely respected Lancet peer-reviewed medical journal recently published an article claiming that Sputnik V is safe and effective, based on interim results from a phase 3 trial. The developers Gamaleya National Research Centre for Epidemiology and Microbiology have a successful track record and their two vector approach – using two types of carrier viruses has been used successfully in the past to vaccinate against Ebola.
The vaccine is outside the EU’s advanced purchasing agreements and can be purchased by any EU member state. Hungary has already had a delivery of 40,000 doses, of an order of over 2 million to be delivered over the next three months. Other EU countries are also considering approval for emergency use, something that they are entitled to do under the current rules, as already shown in the UK last year. The EU, however, has not been willing to take the added risks and liability for this approach and will only deploy the vaccine when it has received conditional market authorisation from the EMA.
Site inspection
Von der Leyen said that lessons had been learned about the need to inspect the process and production on site since the start of the pandemic, alluding to the difficulties experienced by both BioNTech/Pfizer and AstraZeneca. Since there is currently no production of Sputnik V in the EU, this would mean that the EU would need to have an agreement to access and verify production of sites in Russia. This could prove difficult given that diplomatic relations have been weakened following the recent visit by EU High Representative Josep Borrell to Moscow.
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