Chief Nurse Sam Foster holds a vial of the Oxford University / AstraZeneca COVID-19 vaccine at Churchill Hospital in Oxford, South England, on 4 January 2021.
Steve Parsons | AFP | Getty Images
LONDON – The coronavirus vaccine developed by AstraZeneca and the University of Oxford has been approved by the European Medicines Regulatory Authority, the European Medicines Agency.
The EMA said on Friday it had assessed the safety and efficacy of the Covid vaccine and, by consensus, recommended that the European Commission, the EU’s executive, grant a formal conditional marketing authorization.
It is also said that the shot is likely to work in the elderly, after a German vaccination committee on Thursday recommended not giving the vaccine more than 65.
“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” EMA executive director Emer Cooke said on Friday. a statement said.
“As in previous cases, the CHMP has carefully evaluated this vaccine, and the scientific basis of our work supports our firm commitment to protecting the health of EU citizens,” Cooke said, referring to the EMA’s human medicine committee .
The vaccine is already in use in the UK, having been approved at the end of December, and now makes up the bulk of the samples administered in the country, along with the Pfizer-BioNTech shot, which is already authorized to to be used in the country. EU.
The approval comes at a difficult time for the EU, with its vaccination program at its slowest and seems very vulnerable to supply shortages.
It has been dealt two blows in the past few weeks, first by Pfizer, which said it would temporarily reduce production while improving its production capacity at the Belgian plant. Last Friday it was reported that AstraZeneca will deliver far fewer doses to the block in the spring than initially expected, due to production issues at its plants in the Netherlands and Belgium.
The delays have led to a crisis in the EU, which has said it will now restrict the export of coronavirus vaccines from the bloc to prioritize citizens. These checks are expected to last until March.
The EU on Wednesday demanded that AstraZeneca abide by its agreement to supply it with millions of coronavirus vaccines, whatever is needed, indicating that the company is diverting some supplies from its UK production facilities to the EU.
German doubt
Then on Thursday, doubts were expressed about the possible authorization of the vaccine from AstraZeneca after the German vaccination committee said that it is recommended that the vaccine should only be offered to people between 18-64 years.
That said, it was because there were not enough data to determine the effectiveness in people over 65.
Participants in elderly trials were later admitted to Phase Three clinical trials of the AstraZeneca shot, which took place in the United Kingdom and Brazil and earlier in South Africa, so there is less data available on its efficacy in the 65-year-old age.
AstraZeneca said this data would build up when it published the findings of the trial in The Lancet medical journal in December: ‘Since older age groups were recruited later than younger age groups, there was less time to build cases and consequently efficacy data in these groups is currently limited by the small number of cases, but additional data will be available in future analyzes, “he said.
On Friday, when the AstraZeneca approval was announced, the EMA said there are still not enough results in older participants (older than 55) to give a figure for how well the vaccine will work in this group. However, it is said that ‘protection is expected as an immune response is seen in this age group and is based on experience with other vaccines.’