Chief nurse Sam Foster will be holding a vial of the Oxford University / AstraZeneca COVID-19 vaccine at Churchill Hospital in Oxford, South West England on January 4, 2021.
Steve Parsons | AFP | Getty Images
LONDON – The coronavirus vaccine developed by AstraZeneca and the University of Oxford has been approved by the European drug regulator, the European Medicines Agency.
The EMA said Friday that it had assessed the safety and effectiveness of the Covid vaccine and, by consensus, recommended that a formal conditional marketing authorization be granted by the European Commission, the EU’s executive arm.
It also said the shot would likely work in the elderly, after a German vaccine committee on Thursday recommended that the vaccine should not be given to people over 65.
“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to fight the pandemic and protect their citizens,” Emer Cooke, EMA’s executive director, said in a statement Friday. .
“As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work supports our firm commitment to protecting the health of EU citizens,” said Cooke, referring to the Committee for Medicinal Products for Human Use of the EMA.
The vaccine is already in use in the UK, after being approved in late December, and now makes up the bulk of the injections administered in the country, along with the Pfizer-BioNTech injection, which is already approved for use in the EU .
The approval comes at a difficult time for the EU, where the vaccination program is slow at best and looks very vulnerable to a shortage of supply.
It took two blows in recent weeks, firstly from Pfizer, who said it would cut production temporarily while upgrading its production capacity at its Belgian plant. Last Friday, it was reported that AstraZeneca would deliver far fewer doses to the block in the spring than initially expected due to production problems at the factories in the Netherlands and Belgium.
The delays have sparked a crisis in the EU, which has said it will now restrict exports of coronavirus vaccines from the bloc in an effort to give priority to its citizens. These checks are expected to last until March.
On Wednesday, the EU demanded that AstraZeneca honor its agreement to supply it with millions of coronavirus vaccines in every possible way, suggesting that the company directs some deliveries from its UK manufacturing facilities to the EU.
German doubt
On Thursday, doubts arose about the potential approval of AstraZeneca’s vaccine after the German Vaccine Committee said it recommends only offering the vaccine to people between the ages of 18-64.
This, it was said, was because there was not enough data to assess effectiveness in people over the age of 65.
Older subjects were later admitted to the third phase of clinical trials of the AstraZeneca injection, which took place in the UK and Brazil, and previously in South Africa, and therefore less available data on its efficacy in people over 65.
AstraZeneca said these data would increase when it published its study results in December in the medical journal The Lancet: “ As older age groups were recruited later than younger age groups, there has been less time to build up and as a result there are efficacy data in these cohorts 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 were not yet enough results in older participants (over 55 years old) to give a figure of how well the vaccine will work in this group. However, it said that “protection is expected as an immune response is seen in this age group and based on experience with other vaccines.”