Emer COOKE, European Medicines Agency (EMA) Executive Director update MEPs from the Environment, Public Health and Food Security Committee on the state of play in the evaluation and market authorisation of vaccines against COVID-19 and the next steps. And Members of the Budgets Control Committee and the Commission’s Director-General for Health and Food Safety (SANTE), Sandra GALLINA, discuss the current state of the EU’s advance purchase agreement on vaccines against COVID-19.

Brussels

exchange of views

meeting

Committee on Environment, Public Health and Food Safety

Committee on Budgetary Control

HOHLMEIER, Monika (EPP, DE)

healthcare safety (T)

European Medicines Agency

Coronavirus outbreak (T)

COOKE, Emer (IE)

vaccination strategy (T)

GALLINA, Sandra (IT)

Update of purchase, evaluation and authorization of COVID-19 vaccines: extracts from the exchanges of views with Sandra GALLINA, Director-General of DG SANTE (CONT) and with Emer COOKE, EMA Executive Director (ENVI)

Title:  Update of purchase, evaluation and authorization of COVID-19 vaccines: extracts from the exchanges of views with Sandra GALLINA, Director-General of DG SANTE (CONT) and with Emer COOKE, EMA Executive Director (ENVI) (I-203595)

SOUNDBITE (English), Sandra GALLINA, EU&apos;s lead negotiator on Covid-19 vaccines contracts, We will take all the actions that are needed and all the tools that we have to redress the situation. Yes, it is a shame. It is a reputational damage of a huge extent. But it is also a question that many people are dying because the vaccines are not getting here.

SOUNDBITE (English), Sandra GALLINA, In terms of exports, it is true, we are open, we are supporting over 30 countries in the world, we are not closing the possibility to have vaccines. And I would like to say that this has been a clear policy from Europe not to have, I would say, bans and not to have limitations.

SOUNDBITE (German), Monika HOHLMEIER (EPP, DE), Chair of the Committee on Budgetary Control, 1. Question: It seems there have been inequalities between some of the Member states, there have been different orders from the Member states. It would be interesting to know a little bit more about what might have led to these inequalities between the Member states and to what extend?

SOUNDBITE (English), Sandra GALLINA, May I say that the doses belong to the Member states. So for us, it is very difficult for the Commission, to come and have to an idea about the distribution of the doses.

SOUNDBITE (English), Sandra GALLINA, Some countries have received an accelerated pace of deliveries.

SOUNDBITE (German), Monika HOHLMEIER (EPP, DE), 2. Question: How many doses from which company can we expect in April and in May?

SOUNDBITE (English), Sandra GALLINA, (Speaking about the Astra Zenca vaccine production plants in the EU) So at the moment, they are producing from one plant. One plant that was in our contract still needs to be authorised by EMA. The company has only now started the procedure for the authorisation of the plant. So the situation for me, it's clear it's impossible to fulfil a contract if from five plants only one plant is working.

SOUNDBITE (German), Monika HOHLMEIER (EPP, DE), 3. Question: There is a lot of reporting in the news about vaccines being sold on the black market. So what exactly are these problems? How exactly are these vaccine doses then turning up and being sold at a premium price on the black market within the EU?

SOUNDBITE (English), Sandra GALLINA, I'm not sure if anybody has bought these doses, what we know is that OLAF is somehow keeping the situation under control and looking at how these doses are arriving on the market and distinguishing between real doses and fake doses and trying to keep a real track of all these cases. So, as I say, it is extremely important that you realise that this is not underestimated at all.

SOUNDBITE (English), Tilly METZ (Greens/EFA, LU), (question on the Astra Zeneca blood cloth) I would like to know when you expect to be able to really update us on this.For example, if it's true that young women are more affected and if it could also be related to smoking and contraception, for example ?

SOUNDBITE (English), Emer COOKE, Executive Director of the European Medicines Agency (EMA), I just to say, yes, that the majority of the events we have seen have been in women under 55. But in fact, this seems to be the population who has mostly received the the vaccines, the AstraZeneca vaccines in Europe. So it's impossible for us to determine that that is really a population at highest risk.

SOUNDBITE (English), Emer COOKE, I just want to assure you that we are really doing everything we can to make sure we get the information as quickly as possible and that we don't just rely on the spontaneous reports that are coming into the pharmacovigilance system, but where we're launching dedicated studies to specifically investigate for these problems.