EMA defends AstraZeneca vaccine: "A situation like this is not unexpected"

Agency chief reiterates confidence in Oxford vaccine, but will issue final opinion on Thursday

3 min
The Director of the European Medicines Agency, Emer Cooke.

BrusselsThe European Medicines Agency (EMA) has had to come out on Tuesday in the face of the avalanche of European countries which, after eleven serious cases of thrombosis, have preventively suspended the application of the vaccine developed by the Anglo-Swedish pharmaceutical company AstraZeneca, developed by Oxford Laboratories. The director of this European agency, Emer Cooke, has appeared at a press conference to calm the waters and send a message of confidence to the public. According to Cooke, "a situation like this is not unexpected" and, for the fourth time, reiterates that at this point the benefits of administering the AstraZeneca vaccine outweigh its risks because the detected cases of thrombosis are very rare.

This does not mean that the EMA is not studying individually and exhaustively the cases that countries like Norway and Germany have detected to determine whether they are a direct consequence of the vaccine, that is, a side effect, although rare, or if it is just a coincidence. Cooke has insisted that EMA experts are evaluating all available information in order to cast light on the situation. On Thursday afternoon, a new opinion on the subject will be made public.

"A situation like this is not unexpected. When you vaccinate millions of people it is inevitable that there will be incidents. The role of the EMA is to evaluate them to see if they are really side effects or coincidences," said Cooke, who has also acknowledged her "concern" about the effect that all this may have on public confidence in the vaccine.

What to expect from the EMA on Thursday? Its director explained that there is a wide range of possibilities on the table. If it is concluded, as the agency maintains for now, that there is no causal relationship between the cases of thrombosis and vaccination, the EMA will probably reaffirm its recommendation to apply the Oxford vaccine. At the same time, however, it has also assured that if a direct link between these cases and the vaccine is detected, it will act "firmly" as necessary. Other options could be to take into account specific patient profiles to reduce the risks if it is considered a very rare side effect. Cooke, however, has refused to speculate and has reiterated that, for now, these are only hypotheses. What she did do is attempt to dispel all doubts about a possible political intentionality behind the suspension of AstraZeneca's vaccine in the EU: "Our assessment is guided by science and is independent, nothing else."

The Anglo-Swedish pharmaceutical company AstraZeneca is stuck in a spiral of bad news that is damaging its reputation and image. The first was an open war between the European Commission and the company over the announcement of a breach of delivery and contract clauses. And with this conflict still to be resolved -AstraZeneca will not comply this second quarter either-, the thrombosis cases have further complicated the situation when a large part of the countries of the European Union have decided to suspend its application. In the middle of a vaccination campaign that has problems to accelerate, governments have to keep millions of vaccines in the fridge for days when, in addition, they have received less than expected

That is why the European Commission has moved this Tuesday and has agreed with Pfizer/BioNTech the delivery in advance of 10 million doses of its vaccine in the second quarter to "plug the holes" caused by delivery problems. Oxford's is the cheapest vaccine and the one on which most hopes had been pinned, which have been fading. That is why Brussels has extended other contracts even though AstraZeneca is not the only one with problems. Johnson & Johnson also expects delivery defaults after its vaccine was approved by the EMA last week