EMA to send experts to Russian plants and laboratories producing Sputnik V

Brussels blames AstraZeneca for damaging its reputation, prepares to tighten export controls

3 min
A Serbian health worker with the two vaccines used in the country, Russian Sputnik V and Chinese Sinopharm, in a picture taken yesterday

Brussels"We need a wide range of different vaccines to make progress against coronavirus," said Emer Cooke, head of the European Medicines Agency (EMA), last Tuesday. Currently, there are four vaccines authorised in Europe, those of Moderna, Pfizer/BioNTech, AstraZeneca and Janssen, but, as Cooke explained, the EMA is analysing other solutions in development such as Novavax or the Russian Sputnik V, given the need to accelerate the pace of vaccination and the problems with AstraZeneca. Regarding Sputnik V, which comes with a significant political and geopolitical burden, the EMA is already planning the visits of its experts to Russian plants and laboratories, part of the analysis process while waiting for Sputnik V to officially apply for authorisation by the EMA, something that has not yet occurred.

The head of the European regulator has insisted that the Russian vaccine will be analysed with the same criteria as any other, but at the time already explained that additional inspections would be needed considering that it is produced outside European territory. However, Putin's government announced that it already had agreements in place in Italy, Germany, Spain and France to produce its vaccine, which has only been officially confirmed in Italy. In Germany, a spokesperson for the German vaccine manufacturer IDT Biologika admitted this. Sputnik V applied yesterday to be part of the WHO's Covax initiative to deliver vaccines to poor countries

The EMA began reviewing the Russian solution on March 4, but on Wednesday asked for more information to continue in order to activate the authorisation process that the manufacturer itself has to apply for. Hungary is so far the only European country where this vaccine is being administered, but last week the German Minister of Health, Jens Spahn, opened the door to authorising it before the EU if necessary. Governments that choose to dodge EMA authorisation assume more civil liability if problems arise.

Exports and AstraZeneca

The EU is having trouble speeding up the vaccination campaign and blames it mainly on the Anglo-Swedish pharmaceutical company AstraZeneca, which will barely reach a quarter of the doses promised for the first half of the year. The relationship between Brussels and this pharmaceutical company has become a frozen conflict that, far from being resolved, has been complicated further by cases of thrombosis detected in several countries, which led to a halt in the vaccination campaign. Despite the fact that both the EMA and the President of the Commission have defended it, the company continues to breach its agreements. Hence the forcefulness of the Director General of Health Commission, Sandra Gallina: "It is a shame, it is a reputational damage to the Commission and European governments", also highlighting how the lack of vaccines was causing more deaths.

Gallina has pointed to AstraZeneca as the only company that fails to comply with the agreements and has recalled that they will take all necessary measures at the legal level to get the doses they acquired. Brussels launched an export control mechanism as a result of this conflict and on Wednesday the European Commission will present a review of the mechanism in the run-up to the summit of European leaders on Thursday to decide whether to tighten control. The president of the EU executive, Ursula von der Leyen, threatened to block the shipment of European-made doses to the United Kingdom, given the the European Union has agreed to send 10 million doses of the drug to the UK, but none have arrived from the British Isles. For now, it has been agreed to send "a formal warning" to the company in a process that could end up in court.

"Many companies are exporting and are not causing us problems with contracts," said Gallina, who pointed directly to the company that produces the vaccine in the Oxford laboratory. Countries such as Austria and Bulgaria are particularly concerned because they bet mainly on the British vaccine and now find themselves with more shortages than other countries in the Union.

Waiting for Janssen

Although Gallina insisted that it is only AstraZeneca that is causing problems, the long-awaited single-dose vaccine from Johnson & Johnson will not arrive until mid-April. This has been repeated by the Commission spokesperson, who has assured that they are in constant contact with the company and have not discussed the production problems. It is expected that 55 million doses of the vaccine that Janssen produces in Europe, among others, in a factory in Sant Joan Despí, will arrive. With these doses, and the backlog of AstraZeneca vaccines, Brussels still considers the goal of vaccinating 70% of the adult population by the end of summer "achievable". This would mean vaccinating 255 million people completely.