European Medicines Agency chief says safe and effective vaccine will not be ‘silver bullet’ on its own

EMA Executive Director Emer Cooke said, “A vaccine will become a key component but, on its own, it will not be the silver bullet which will allow us to return to normal life.”

By Martin Banks

Martin Banks is a senior reporter at the Parliament Magazine

10 Dec 2020

On Thursday, Cooke updated MEPs on the Environment, Public Health and Food Safety Committee on the latest developments concerning the authorisation of COVID-19 vaccines.

She said that the vaccine “must also be combined with other things currently being done, including social distancing, wearing facial masks and other public health measures. These will all still be needed to control the spread of the virus.”

“This will be necessary for several months and also while vaccinations are taking place.”

She told members, “We do know a lot more about the disease than we did 12 or 6 months ago, but there is still a lot to learn and extensive work is still needed post-authorisation of a vaccine.”

The European Medicines Agency has recently received two applications for conditional marketing authorisation for two COVID-19 vaccines: one developed by BioNTech and Pfizer and one by Moderna Biotech Spain, S.L.

The EMA’s scientific committee for human medicines is expected to conclude its assessments on the Pfizer/BioNTech and Moderna vaccines in the coming weeks.

“We do know a lot more about the disease than we did 12 or 6 months ago, but there is still a lot to learn and extensive work is still needed post-authorisation of a vaccine” Emer Cooke, EMA Executive Director

Cooke said it is hoped that the EMA will be able to give authorisation of a vaccine later this month.

She said, “We are, of course, aware of the UK decision to grant authorisation on 2 December and that Canada adopted similar emergency measures on Wednesday and the United States regulatory authority may do so this week.”

“We are following all this with great interest. I will not comment on these but might stress that these are authorisation for the temporary use of unlicensed vaccines.”

She said that once the EMA and the European Commission authorise a vaccine it will be “valid in all Member States at the same time.”

“That means that all Member States, big or small, will benefit from this work and can then prepare for vaccine campaigns at the same time.”

She stressed, “Speed is of the essence but safety is our number one priority and I am keenly away of the huge responsibility to get these decisions right in order to protect the EU population.”

“Speed is of the essence but safety is our number one priority and I am keenly away of the huge responsibility to get these decisions right in order to protect the EU population” Emer Cooke, EMA Executive Director

“Our assessment will be fully independent and based on scientific evidence about the safety of a vaccine. Transparency and effective communication are also critically important and the EMA will publish a full assessment report within 3 days of a Commission decision. We will also publish a risk management plan.”

She said the EMA had “interacted with many vaccine developers” and that some of these may not be approved until the first half of 2021.

“There are still many concerns about these new vaccines and this is part of the debate about vaccines on social media. It is also about the misinformation about vaccines that is in circulation. We need to understand the concerns of the public so we can address them. But it is vital we have the trust and confidence of the public.”

She pointed out that the EMA holds a public meeting about vaccines on Friday, saying, “This is a chance to know how to understand such public concerns.”

Cooke told the Committee that the EMA process for assessing and authorising a vaccine “follows the same steps” as other regulatory authorities around the world but that this was being done in an “expedited manner.”

“I must stress that authorisation provides for an agreed plan with legally binding obligations. It will be valid for one year and can be revoked at any time.”

She added, “Post authorisation, we need to monitor the safety of all vaccines so that we can take swift action if necessary. We are currently working with other regulatory authorities to ensure we can move as soon as possible on authorisation.”

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