EMA director: Europeans are better protected with ‘EU licensed’ COVID vaccine

The EMA chief expects her team to finish reviewing Pfizer's application before 29 December. The team will only be able to review Moderna's application by 12 January because it has received less clinical tests and necessary information is still being exchanged.  Emer Cooke/EFE-EMA [Emer Cooke/EFE-EMA]

In an exclusive interview in Amsterdam with EURACTIV’s partner EFE, Emer Cooke, the executive director of the European Medicines Agency (EMA), stressed that Europeans are much “better protected” if the COVID-19 vaccine is authorised by the EU agency.

All COVID-19 vaccines – including the new ones to come – must be analysed before giving a “consistent authorisation that can be implemented at the beginning of the year (2021)”, said Cooke, adding that the EMA has no specific preference with regard to a COVID-19 vaccine in particular.

On the UK being the first country in Europe to have already started started its COVID-19 vaccination programme, Cooke did not want to be more explicit. It would be better to wait until EMA’s “certification” of safety and quality, she added.

‘We work very hard to meet citizen’s expectations’

The fact that, so far, the majority of COVID-19 vaccines have an efficiency rate of around 90% is “very good news”, said Cooke. The EMA chief pointed out, however, that this is “the analysis of the companies”. EU authorities “must confirm” that the studies carried out so far are sufficient.

“We are working very hard to meet the expectations of the European population,” she said.

Before starting work in her new position last October in Amsterdam, Cooke was director of the Department of Regulation and Prequalification of the World Health Organisation (WHO) in Geneva, and has almost three decades of experience in matters of international health regulation which is now being implemented by the EMA.

Data from Pfizer, BionNTech and Moderna to be carefully reviewed

A week ago, the EMA received formal requests for a conditional authorisation from pharmaceutical companies Pfizer/BionNTech and Moderna for the use of their vaccines in the EU, after the UK began vaccinating its citizens on Tuesday without having to wait for the review.

The EMA chief expects her team to finish reviewing Pfizer’s application before 29 December. The team will only be able to review Moderna’s application by 12 January because it has received less clinical tests and necessary information is still being exchanged.

“We want to be very sure that we review the data carefully. We have to decide the conditions that the pharmacist must meet once it achieves conditional authorisation. Doing that well takes time (…) We have to put everything together to give an authorisation that is consistent and that we are sure that it can be implemented early next year ”, she explained.

Pending EMA’s results, Hungary has shown interest in the Sputnik V vaccine developed by Russia, which is not being analysed by the EMA.

“We really believe that patients are better protected with a licensed vaccine, but if there is a situation where there is a very high public need and the drug company or the country says that the benefits outweigh the risks for their population, then they are free to allow the temporary use of a product without a license,” she added.

“Conspiracy theories” and “anti-vaccines”

The EMA “takes very seriously everything related to communication about the benefits and risks of vaccines, in particular in a world where there is so much fake information everywhere,” said Cooke, adding that such information tries to create distrust of scientific work.

Addressing this issue is also a EMA’s responsibility, according to Cooke. The agency will work to ensure it is “the definitive and reliable source of information on vaccines,” she added.

The EMA will also work towards helping to build trust among the population and will implement a communication strategy against “conspiracy theories and anti-vaccine” activists, Cooke added.

[Edited by Daniel Eck and Frédéric Simon]

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