EMA approves AstraZeneca's vaccine for over-18s

BrusselsThe European Medicines Agency (EMA) has authorised the Oxford/AstraZeneca vaccine for people over the age of 18. In a statement, the European agency considers the vaccine to be safe, although it admits that "there are insufficient results for people over 55 years of age". At the same time, however, it states that given the experience with other vaccines and the experience seen in other age groups, it considers that it can also be applied to older people.

On Monday, the agency's director, Emer Cooke, had already anticipated a lack of data on the vaccine's impact on one of the age groups most in need of it, the over-65s, but the agency has finally given the vaccine full approval.

The decision has come the day after the agency that advises the German government on vaccination had already recommended not administering it to older people. According to several German media reports, the group of people over the age of 65 who received the vaccine in the studies that the company had to submit to the authorities for approval consisted of only 341 people. But a draft of the report was leaked, becoming another chapter in the conflict between the European Union and the Anglo-Swedish company AstraZeneca. This Friday, German Health Minister Jens Spahn expressed that he did not expect full authorisation by the EMA and has reiterated that "there is a difference between saying that there is not enough data and that the data are bad".

The head of immunisation of the Public Health Agency of the United Kingdom, Mary Ramsay, quickly stepped in to assure that the Oxford vaccine is as safe as the Pfizer vaccine. It should be remembered that the UK gave emergency approval for the vaccine on 30 December, when it was still part of the European Union. This early authorisation is one of the explanations for the faster speed of vaccination in the UK compared to the EU.

Higher expectations

The vaccine developed by the Oxford laboratory requires two doses to complete the immunisation process. Compared to the Pfizer/BioNTech and Moderna vaccines, it is much easier to store and handle - it can be kept at conventional refrigerator temperatures of between 2 and 8 degrees Celsius - and so expectations were highest regarding its possibilities for mass vaccination: "The disappointment is immense, because it was supposed to be the first to be authorised for mass production. Then we were lucky that Pfizer and Moderna had it before", said an EU source this week

After the EMA has authorised the Pfizer and Moderna vaccines in the Union, the European Commission quickly activated the commercial authorisation, in under 24 hours, allowing the vaccination campaign to start immediately. However, the conflict between this pharmaceutical company and the EU is precisely that AstraZeneca cannot comply with the planned distribution of doses once the authorisation has been obtained, it says that this is due to performance problems at two of its plants in Europe. On the other hand, the EU highlights that the pre-financing it has provided so far was meant precisely to increase production capacity so that the vaccine could be administered to a large amount of population once it was authorised.