As the EU's 27 member states scramble to contain the spread of new "mutant" strains of the Covid-19 virus, the head of the European Medicines Agency, Emer Cooke, tells FRANCE 24. [ Ссылка ] There are "promising" results from early studies into how well existing vaccines work against the new variants. The so-called "UK variant", otherwise known as strain B.1.1.7, transmits more easily from person to person and there are predictions that it will become the dominant strain within weeks.
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EMA Executive Director Emer Cooke says that ongoing preliminary studies look "promising" – and that the EMA has asked vaccine producers to plan studies to prove their results "conclusively".
Meanwhile, a growing list of European states are casting doubt on the efficacy, in people aged over 65, of the vaccine developed by Oxford University and AstraZeneca – one of the three authorised vaccines in the EU.
Health authorities in France, Germany, Italy, the Netherlands and Sweden have all recommended the jab only be used in adults aged up to 65.
When asked whether the Oxford/AstraZeneca jab is safe in over-65s, Cooke tells FRANCE 24: "We've looked at the immunity issue across different age groups – and the safety issues, because the safety profiles were looked at in adults over 65. And we don't see a reason to say it should not be recommended for adults over 65."
The EMA head also tackles vaccine hesitancy and the questions of how the vaccines were developed so quickly, and whether they are safe – underlining that "the processes that have been followed are the standard processes for any vaccine".
"It's important to remember that there was an enormous amount of multi-stakeholder engagement to really mobilise the processes necessary to focus in on the virus, to do the development process, to make sure that manufacturing capacity was available. And we have very, very large data sets… Which gives you a very good understanding of the efficacy and safety in the populations," she explains.
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Von der Leyen has defended that the three or four extra weeks that the EMA has taken are “an essential investment in trust and security“At the same time, he announces that from now on the EU will go faster. His argument is that now the vaccines against Covid-19 are already known, so the EMA will be able to approve any adaptation based on a lower volume of supplementary data.
The doubts about Sputnik
Von der Leyen has taken advantage of the press conference to present the plan to sow doubts about the Russian vaccine Sputnik V, which some Member States (in particular Hungary) see as a solution to the current shortage of vaccines in the EU. The president stressed that the manufacturer still has not submitted an authorization request to the EMA: the Budapest Government has approved it at its own risk and expense.
“If they send the request, they have to present an entire data set and pass the entire scrutiny process, like any other vaccine “, has related Von der Leyen. The other great difficulty for the Russian vaccine to be used in the EU is that” they are not producing in Europe “.” There should be an inspection procedure in the manufacturing plants, because one of the crucial points is to have a stable, high-quality production process. “
Why the European Union will not use the Russian Sputnik vaccine?
But also, the community Executive it is not clear that the doses that Sputnik promises exist or can be manufactured in the short term, which is when they would be needed. “Overall, I have to say that we are still wondering why Russia is theoretically offering millions and millions of doses while they are not making sufficient progress in vaccinating their own population. This is also a question that I think needs to be answered.” , said the president.
Detect mutations
The second pillar of Von der Leyen’s plan against mutations is to detect, analyze and evaluate new variants. Brussels will allocate 75 million euros to have specialized tests and support genomic sequencing in Member States. The goal is to sequence at least 5% of the positive tests in order to identify new strains, monitor their spread, and examine their impact on transmissibility.
In addition, the Commission has reserved a further € 150 million for enhance research and data exchange on mutations. To this end, a network of clinical trials on Covid-19 will be launched, in which 16 Member States and five associated countries have already shown interest, including Israel and Switzerland.
The third pillar aims to accelerate the production of vaccines against Covid-19 in the EU.
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