EMA maintains defense of AstraZeneca's vaccine: "It is safe and effective"

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AstraZeneca's vaccine in the Hospital Universitario Central de Asturias

BrusselsThe European Medicines Agency (EMA) stands firm. AstraZeneca's vaccine is "safe and effective" and the benefits it brings by way of protection against coronavirus outweigh the risks, the head of the European agency reiterated at a press conference on Thursday.

The European regulator has taken this decision after about twenty countries in the European Union, including Spain, have suspended the use of the vaccine developed by Oxford University after detecting several cases of thrombosis in people who had been immunised. Governments such as those of Spain, France, Italy or Germany were waiting for this ruling to resume or not the vaccination campaign with these doses, taking into account that the rate of immunisation in the European Union is falling far behinf that of the United States or the United Kingdom, for example. At this point, not even 10% of the European population has been vaccinated with a single dose.

Earlier this week, EMA director Emer Cooke appeared to calm the waters after France, Spain and Germany joined in suspending use of AstraZeneca's vaccine, setting off a domino effect that has led to a crisis of reputation and confidence in the vaccine. On Tuesday, Cooke defended the British laboratory's solution (for the fourth time since the first cases of thrombosis were detected): "The benefits outweigh the risks," she reiterated. And the same position has been maintained until today by the World Health Organization (WHO). Despite this, she announced that a thorough review was being done on a case-by-case basis, which is what has been communicated this Thursday.

Thrombosis is a cerebrovascular disease that causes a blood clot and impedes circulation in the venous system of the brain. It is rare and generally affects more young women, for whom birth control pills and hormone therapies as specific risk factors. The specific cases that triggered the alarms were detected in Germany, Norway and also in Spain, but around forty have been detected among the more than 17 million people who have received the vaccine in the EU and the UK. Countries such as Spain justified the suspension as "prudent" despite the EMA and WHO insisting on the vaccine's safety. Germany said the same on Monday after seven people aged between 20 and 50 showed symptoms 16 days after the injection. German Health Minister Jens Spahn said Germany would wait for the EMA's decision before reintroducing the vaccine.

In the case of Spain, the Ministry of Health announced Wednesday that, if the EMA recommends maintaining the vaccination, would immediately convene an Inter-territorial Health Council to decide whether the campaign should be resumed, so it will not be an automatic reactivation.

The importance of the Oxford vaccine

The problems with the Oxford vaccine are not only European. The WHO's Covax initiative to deliver doses to poor countries also relied heavily on this vaccine because it is one of the cheapest options on the market (about three dollars) and because there were high expectations on it at the beginning of the pandemic. In fact, 99% of the 330 million doses planned in this initiative for the first half of this year are from Oxford. In Africa, some 25 countries have already administered doses of this vaccine through Covax, although some, such as Congo and Cameroon, have also temporarily suspended vaccination with these doses

Another advantage of this vaccine is that it is easy to store. It can be kept at the temperature of a conventional refrigerator, between 2ºC and 8ºC degrees, unlike those of Moderna or Pfizer/BioNTech, which require much lower temperatures (-20ºC for the former and -70ºC for the latter).

Tension between Brussels and AstraZeneca rises

Meanwhile, relations between the European Commission and AstraZeneca are not improving. The company notified the EU a few weeks ago that it would not meet its delivery targets this time either: it will only manage to hand over 70m doses - under half the number it committed to. The European Commission has explained it is planning to trigger the arbitration mechanism to take the pharmaceutical to court for failing to uphold its end of the contract. According to the signed contracts, the case will be heard in Belgian courts. The Commission has prepared a letter which will set the process in motion, and now only needs Member States' approval to send it.