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Summary of the EMA public stakeholder meeting on the approval and roll-out of COVID-19 vaccines in the EU

Last Update 06/04/2021

On Friday 8 January 2021 the European Medicines agency (EMA) hosted an online, public stakeholder meeting on the approval and roll-out of COVID-19 vaccines in the EU.   

The event focused on the key aspects of how the Moderna and Comirnaty (Pfizer/ BioNTech) vaccines have been assessed, approved and will be rolled out across the EU.

The EMA took onboard previous feedback that their stakeholder meetings should be more accessible to the public. Therefore, this meeting was developed with this in mind and used easy to understand language and went into more detail about areas that non healthcare professionals may not understand. Access the full meeting and all of the presentation slides.

The meeting was introduced by Emer Cooke, EMA Executive Director, and was chaired by Noel Wathion, EMA Deputy Executive Director.

Representatives discussed the approval and roll-out of COVID-19 vaccines in the EU: 

  • Basis for the EU approval of new vaccines – Harald Enzmann (Chair of human medicines committee: CHMP)
  • How the safety of the new COVID-19 vaccines will be monitored – Sabine Straus (Chair of safety committee: PRAC)
  • The European Commission’s role in the authorisation process and facilitation of roll-out vaccination – John Ryan (Director for Public Health, DG SANTE, EC)
  • Ongoing actions for roll-out vaccination at national level – Nikolai Brun (on behalf of Heads of Medicines Agencies)

 There was then a public session with speakers and a panel of experts who included:

  • Melanie Carr (Head of Stakeholders and Communication Division, EMA)
  • Fergus Sweeney (Head of Clinical Studies and Manufacturing, EMA)
  • Peter Arlett (Head of Data Analytics and Methods, EMA)
  • Marco Cavaleri (Head of Biological Health Threats and Vaccines Strategy, EMA)

Here we have summarised some key points from EMA that answer some questions ELF has received about COVID-19 vaccine development.

How long will protection from the vaccines last?

We do not know how long the vaccine protection will last. We will find out by following clinical trial participants for up to 2 years and by following how many COVID-19 cases occur globally as the vaccines are rolled out.

Can people who have had the vaccine still spread the virus without getting ill themselves?

We do not know yet, and we will not know until enough people have been vaccinated. Until we do know, the steps that are in place to limit infections, such as hand washing, social distancing and face coverings, should not be relaxed. 

Can people who have had COVID-19 still have the vaccine?

Yes – we do not have a lot of data about the effects of the vaccines on people who have already had COVID-19, but it does not seem to have any additional side-effects in these people. At the moment, we do not know how well it works for them and this is something we will learn as the trials and vaccinations continue. 

Can children have the vaccines?

Children have not been included in the clinical trials. Comirnaty has been approved for people over 16 and the Moderna vaccine for over 18s. These ages are based on the age of participants in the clinical trials. 

Can people who are immuno-compromised use the vaccine?

Yes, people with impaired immune systems can use the vaccines, but they may be less effective and build fewer antibodies to the virus, as with other vaccines in this group.

Can pregnant and breast feeding people use the vaccine?

There is very little data about this, and it should be considered on a case-by-case decision with the pregnant person’s doctor.

How will the safety of the new COVID-19 vaccines will be monitored?

Data are still being collected from the clinical trials and from the population. As this information comes in it is continuously assessed for safety, and steps will be taken if any vaccines are thought to be unsafe.  

This is why it is so important to report any reactions you have had that you suspect are due to the vaccine.

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring#reporting-side-effects-section

http://www.adrreports.eu/

Have there been severe side-effects to the vaccines?

As with any medications, there will be side-effects and in some cases these may be severe, such as anaphylaxis. The vaccines are being closely monitored and assessed on an ongoing basis. It is important to report any adverse reactions that you suspect are related to having the vaccine. The vaccines are conditionally authorised and if there are a large number of reactions, or there are reactions that are unexpected and deemed unsafe for the public, the vaccine authorisation will be re-assessed.

Report adverse reactions: http://www.adrreports.eu/

Is it safe to extend the time between first and second dose as we have seen in some countries?

Trials have been performed under specific conditions; under these conditions we have this high efficacy. We cannot say a clear cut off time between vaccine doses that is safe or effective at the moment. We can only approve the time scale that was tested.

Should we worry about anaphylaxis with the vaccines?

If someone has a reaction to the first injection, then they should not get the second dose.

Anaphylaxis is very rare, around 1 in 100,000, and can be treated by healthcare professionals. They are aware of the risk and should be prepared and know the amount of time to keep patients under observation. Anaphylaxis relating to the vaccines is being closely monitored, please report it if you experience this side-effect.

Is EMA making suggestions about who should receive the vaccine first?

It is the responsibility of each member state to decide how vaccines will be allocated and to which groups first. Many factors will play into this including logistics.

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