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European Commission president raises doubts over Sputnik V

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Sputnik V vaccine

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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Ensuring smooth air travel while checking EU Digital COVID Certificates: New guidelines for member states

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Following the launch of the EU Digital COVID Certificate on 1 July, the European Commission has issued guidelines for EU member states on the best ways to check them before travel, ensuring the smoothest possible experience for air passengers and staff alike. The non-mandatory EU Digital COVID Certificate provides either proof of vaccination, shows if a person holds a negative SARS-COV-2 test result, or has recovered from COVID-19. Therefore, the EU Digital COVID Certificate is essential to support the re-opening of safe travel.

As passenger numbers will rise over the summer, an increased number of Certificates will need to be checked. The airline sector is particularly concerned by this since, in July for example, air traffic is expected to reach more than 60% of 2019 levels, and will rise thereafter. Currently, how and how often passenger's Certificates are checked, depends on the holder's departure, transit and arrival points.

A better-coordinated approach would help avoid congestion at airports and unnecessary stress for passengers and staff. Transport CommissionerAdina Vălean said: “Reaping the full benefits of the EU Digital COVID Certificate requires the harmonization of the verification protocol. Cooperating for a ‘one-stop' system to check the certificates makes for a seamless travel experience for the passengers across the Union.”

To avoid duplication, i.e. checks by more than one actor (airline operators, public authorities etc.), the Commission recommends a ‘one-stop' verification process prior to departure, involving co-ordination between authorities, airports and airlines. Moreover, EU member states should ensure that the verification is carried out as early as possible and preferably before the passenger arrives at the departure airport. This should ensure smoother travel and less burden for all involved.

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COVID-19

EU agrees to recognize Swiss COVID certificates

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Today (8 July) the European Commission adopted a decision recognizing Swiss COVID-19 certificates as equivalent to the EU Digital COVID Certificate. This should considerably ease travel between Switzerland and its neighbours.

Switzerland is the first country from outside the 30 countries of the EU and EEA area, to be connected to the EU’s system. The Swiss COVID certificates will be accepted in the EU under the same conditions as the EU Digital COVID Certificate. Swiss nationals, EU citizens, and third-country nationals legally staying or residing in Switzerland will be able to travel inside the EU under the same conditions as holders of an EU Digital COVID Certificate. 

Justice Commissioner, Didier Reynders, said: “I warmly welcome that the Swiss authorities have decided to implement a system based on the EU Digital COVID Certificate. This will allow EU citizens and Swiss nationals to travel safely and more freely this summer.” 

Switzerland shall be connected to the EU Digital COVID Certificate trust framework.

Talks are still ongoing with the UK and other third countries.

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COVID-19 Therapeutics Strategy: Commission identifies five promising candidate therapeutics

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The EU Strategy on COVID-19 Therapeutics has delivered its first outcome, with the announcement of the first portfolio of five therapeutics that could soon be available to treat patients across the EU. Four of these therapeutics are monoclonal antibodies under rolling review by the European Medicines Agency. Another one is an immunosuppressant, which has a marketing authorisation that could be extended to include the treatment of COVID-19 patients.

Health and Food Safety Commissioner Stella Kyriakides said:“We are taking the first step towards a broad portfolio of therapeutics to treat COVID-19. Whilst vaccination is progressing at increasing speed, the virus will not disappear and patients will need safe and effective treatments to reduce the burden of COVID-19. Our goal is clear, we aim to identify more front-runner candidates under development and authorise at least three new therapeutics by the end of the year. This is the European Health Union in action.”

The five products are in an advanced stage of development and have a high potential to be among the three new COVID-19 therapeutics to receive authorisation by October 2021, the target set under the Strategy, provided the final data demonstrate their safety, quality and efficacy. See the Press Release and a Questions and Answers for further details.

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