European Medicines Agency (EMA) Director Emer Cooke told MEPs that the authorisation process in the UK is for a “temporary use of an unlicensed vaccine.”
She said the UK has, so far, authorised vaccines from three different pharmaceutical companies on this basis.
The ability to quickly approve vaccines from so many companies - the EU has approved only two by comparison - is seen as one reason why the UK has managed to massively ramp up the vaccination campaign.
But Cooke added, “This temporary facility, however, is not in the remit of the EMA.”
Cooke was appearing before members of the Environment, Public Health and Food Security (ENVI) Committee on vaccine authorisation, availability and deployment.
Some MEPs challenged the agency’s role in the rollout, with Irish deputy Brian Kelleher asking Cooke why the EMA appeared to be slower in giving authorisation to vaccines to treat the virus.
But Cooke sought to defend the EMA’s “robust” process for approving vaccines, saying “I am confident such a robust review can be relied upon in all Member States.”
AstraZeneca has incensed the EU and Member States by warning that it will be able to deliver only 25 percent of the doses scheduled for delivery in the first quarter of the year once the European Medicines Agency has given its approval, as is expected on Friday.
“Blinded by their aspirations of power and control, the European Commission has failed miserably in their vaccine strategy. The rash and politically-motivated decision of centralising decision-making has now directly endangered the health of many Europeans” Rob Rooken, ECR
Analysis by Airfinity, a UK-based analytics company working for the life sciences industry, suggests the UK will have achieved effective “herd immunity” by vaccinating 75 percent of the adult population by 14 July, while the EU will have to wait until 21 October based on supply deals and the latest delays.
While the UK has administered the first vaccine doses to about 10 percent of adults and plans to vaccinate the most vulnerable 15 million - including all over-70s - by mid-February, the EU has reached 2 percent so far.
The UK says all over 50s will be given a jab by March. The EU, comparison, says it will be September at the earliest before vaccinations are given, and then only to 70 percent of EU citizens.
Speaking to this site, ECR member Rob Rooken strongly castigated the EU on its performance in the rollout.
He said, “Pride comes before destruction, and an arrogant spirit before a fall. Blinded by their aspirations of power and control, the European Commission has failed miserably in their vaccine strategy. The rash and politically motivated decision of centralizing decision-making has now directly endangered the health of many Europeans.”
ENVI Committee member, ID French MEP Joëlle Mélin, also criticised the EU vaccine strategy while Belgian MEP Frédérique Ries, another member of the Committee, described the rollout as “unacceptable.”
In her address to the Committee, Cooke also addressed other related issues, including the interval between doses for the vaccines.
She said that Pfizer recommended 21 days between the first and second doses, while it was 28 days for the Moderna vaccine, which has also been approved by the EMA.
“While the UK has administered the first vaccine doses to about 10 percent of adults and plans to vaccinate the most vulnerable 15 million - including all over-70s - by mid-February, the EU has reached 2 percent so far”
In an attempt to defuse the ongoing vaccines dispute between the EU and UK, Cooke also told the members, “It is true that the AstraZeneca vaccine was given temporary authorisation in the UK before it was submitted to the EMA.”
“We are still receiving data on the AstraZeneca vaccine. It is coming in all the time and helps us to understand better how this vaccine performs.”
She said the EMA was “in close collaboration” with international regulators, including the UK.
The official, in a 90-minute session, was also quizzed about other variants of the virus.
On this, she said, “This is an issue on everyone’s mind: how all the vaccines will react to the new variants of Coronavirus, including those already authorised by the EMA and others.”
“We have now asked the various companies to look at these variants on the performance of their vaccines and whether there is a problem.”
She told the Committee, “The initial indication is that these vaccines will continue to be effective, at least in the case of the UK variant.”
Cooke admitted, “The African variant is more complicated and we will need more information on that. These continuous mutations of the virus are to be expected. It is the same with any virus.”
“I want to assure you that we are also working with a number of therapeutic possibilities, 180 in total, and have authorised one. When there is sufficient data we will evaluate these.”
“We are also working with Israel because the Israeli experience has been interesting to observe and to see if what they have done there can be applied here in Europe.”
Cooke, when further quizzed, said she “accepted that the EMA should definitely look at being more present in the media” about the rollout of vaccines.
“That would be valuable,” she said.