New vaccine approved: UK drug regulator gives green light to Astrazeneca-Oxford jab
The coronavirus vaccine developed by AstraZeneca and the University of Oxford has been approved for use by the European Medicines Agency (EMA).
The vaccine is already in use in the UK, where it was approved at the end of December and is currently the main vaccine drug for the population, along with the Pfizer-BioNTech vaccine, which is already approved for use in the European Union..
The approval comes at a difficult time for the EU, as its vaccination program looks weak and very vulnerable to a shortage of drug supplies.
The European Union has suffered two blows from suppliers in the past few weeks, most notably from Pfizer, which said it would temporarily cut production while it upgrades production facilities at its Belgian plant. Then last week there was a message that AstraZeneca in the spring it will supply much fewer doses to the eurozone than originally expected, due to production problems at its factories in the Netherlands and in the same Belgium.
Information about the delays has caused extreme concern in the EU, which prompted its leaders to discuss measures to limit the export of coronavirus vaccines from the European bloc in favor of the priority of the vaccination program for its citizens, which is not surprising..
On Wednesday, the EU demanded that AstraZeneca fulfill its agreement to supply millions of coronavirus vaccines by whatever means necessary, suggesting that the company reroute some supplies from its UK manufacturing facilities to the EU..
Then, on Thursday, doubts arose about possible approval for the use of the AstraZeneca vaccine after the German vaccine committee said it recommends offering the vaccine only to people between the ages of 18 and 64..
This, he said, happened because not enough data was provided to assess the effectiveness of the drug in people over 65 years old..
Elderly trial participants were later admitted to the third phase of clinical trials of the AstraZeneca vaccine, conducted in the UK and Brazil, and previously in South Africa, so there is less data on its effectiveness in people over 65 years of age..
AstraZeneca said the data will be collected when it publishes the study’s findings in the medical journal The Lancet in December: «Because older age groups were recruited later than younger age groups, there was less time to accumulate cases and, as a consequence, efficacy data in these cohorts is currently limited to a small number of cases, but additional data will be available in future analyzes.», – said in the message.