On Wednesday, the British pharmaceutical company AstraZeneca shared all available data on their corona vaccine, which was developed in collaboration with the University of Oxford, with the European Medicines Agency (EMA). However, they say in a press release that they want to wait for additional information from trials that are still ongoing.
Things have gone very fast in the UK for the AstraZeneca and Oxford corona vaccine. Some time ago there was still doubt about the results of their trials, but Monday there was suddenly good news. Two days later, the UK was the first country in the world to get the vaccine right. They even want to start administering that vaccine there next Monday.
Application at EMA
Immediately after that, the question arose whether and when the Oxford and AstraZeneca vaccine would be approved in the European Union. Earlier this week, the European Medicines Agency (EMA) tempered expectations in Het Nieuwsblad. They would not even have received an application yet.
That is the case now. “We can confirm that we have submitted all data in support of a conditional marketing authorization application for the AstraZeneca Covid-19 vaccine with the European Medicines Agency,” said a company spokesperson.
Shortly afterwards, EMA responded to that request on its website. In it, they state that they have indeed received the information, but that they need additional information about the quality, safety and effectiveness of the vaccine. EMA is waiting for the results of a number of ongoing trials for this. They should be known in January.
According to Reuters, there are two issues on which the European watchdog wants more clarity. First, there is the level of protection after the first dose of the vaccine. This must provide sufficient protection because people who have been vaccinated are still exposed to the virus.
In addition, according to them, there is also a lack of clarity about when the second injection should be given. “Some people in the trials received the second dose four weeks later, others 12 weeks later. It was all very variable. That is why it is very difficult to interpret these studies ”, says a source within EMA.