The European Medicines Agency (EMA) announced this Friday the approval of the Covid-19 vaccine developed by AstraZeneca and Oxford University. The vaccine, the third to be recommended in the community, can be used in patients over 18 years of age.
After the Pfizer and Moderna vaccines, the European Medicines Agency also approved the inoculation of AstraZeneca, assuring citizens of the 27 Member States that the vaccine meets European Union standards.
“With this third positive response, we have further expanded the vaccine arsenal available to member states of the European Union and the European Economic Area to combat the pandemic and to protect citizens,” said Emer Cooke, EMA executive director.
She further adds that the “combined results” of four different clinical trials in the United Kingdom, Brazil and South Africa have shown that “the vaccine is effective in preventing Covid-19 in people over the age of 18”.
“Protection is expected” over 64
The vaccine was approved in Europe without a maximum age limit. “Most participants in these studies were between 18 and 55 years old. There are still not enough results in older participants (over 55 years old) to give us data on how well the vaccine will work in this group. if there is protection, since an immune response is observed in this age group, and also based on experience with other vaccines “, refer the experts.
However, “more information from ongoing studies, which include a greater proportion of older participants, is awaited,” EMA experts add.
On Thursday, the German authorities recommended the administration of this vaccine only to users between 18 and 64 years old, justifying the decision with the lack of data on the effectiveness of this inoculation in older patients.
“The AstraZeneca vaccine, unlike mRNA vaccines, should only be administered to people aged between 18 and 64,” pointed out the German experts.
Like previous vaccines approved by the European Medicines Agency, the AstraZeneca vaccine is also divided into two doses, the second of which can be given between four to 12 weeks after the first.
The Oxford / AstraZeneca vaccine represents an important step forward in combating Covid-19, as it is easier to store and distribute than, for example, the Pfizer / BioNTech vaccine, which should be stored at temperatures around – 70ºC.
“Broad and equitable access”
The approval of this new vaccine within the European bloc comes at a troubled and controversial moment between the pharmaceutical and European institutions. The British laboratory recently announced that it will not be able to comply with the supply contracted with the European Commission.
After an arm wrestling that has lasted for a few days, Brussels published this Friday the contract signed with AstraZeneca, intending to show that the pharmaceutical company is failing with its commitments.
At the beginning of the week, AstraZeneca’s CEO indicated that it would not be possible to comply with the number of doses expected by the European bloc in the first quarter of 2021. But at the same time, the pharmaceutical company guaranteed to the United Kingdom the production of two million weekly doses for the country, in order to comply with the contract with Downing Street, in the amount of 100 million doses.
Pascal explained in an interview that “the agreement with the United Kingdom was reached in June, three months before the agreement with the European Union” and that the contract with London states that “manufacturing in the UK goes first to the UK supply chain United”.
This Friday, in a statement after approval by the European Medicines Agency, AstraZeneca welcomed the decision of European experts. Pascal Soriot asserts in today’s statement that he is working “with Governments, international organizations and employees around the world to ensure broad and equitable access” to the vaccine.