EMA stakeholder meeting

EMA Broadcast- how safe and effective vaccines are developed and authorised in the EU?

On Friday 11 December, the European Medicines Agency (EMA) hosted an online stakeholder meeting on COVID-19: how safe and effective vaccines are developed and authorised in the EU?

At the meeting representatives from the EMA discussed how COVID-19 vaccines are developed, how they are evaluated and how safety is monitored.

• Welcome and introductions – Emer Cooke (EMA Executive Director) and Noël Wathion (EMA Deputy Executive Director)
• How COVID-19 vaccines are developed – Marco Cavaleri (Head of Biological Health Threats and Vaccines Strategy)
• EU’s regulatory process for evaluation and approval of vaccines – Fergus Sweeney (Head of Clinical Studies and Manufacturing)
• Safety monitoring of COVID-19 vaccines – Peter Arlett (Head of Data Analytics and Methods)
• Transparency, engagement and communication – Melanie Carr (Head of Stakeholders and Communication)

During the second half patients/carers, consumers/citizens, industry, healthcare professionals and academics could present and ask questions to the EMA. 

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

You can watch the full meeting and access the slides and other resources from the day here: https://www.ema.europa.eu/en/events/public-stakeholder-meeting-development-authorisation-safe-effective-covid-19-vaccines-eu

EMA also have a COVID-19 vaccine key facts page which is a useful resource:  https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines-key-facts

• How do we know that the vaccines will be safe or effective for people with underlying conditions?

There has been an effort to include people with underlying conditions in the studies. Although the numbers are not yet known, there should be at least 1 in 10 people in the trials that have an underlying condition. Once the data are released, the EMA will be open about the number of people in the studies who had underlying conditions.

• Women, pregnant people, the elderly, and people from marginalised groups are often less represented in clinical trials. Will the EMA take this into account when making decisions about the safety of the vaccine?

In each trial there should be around 1 in 4 people who are over 65. Women and people from marginalised groups should also be well represented. EMA will consider these factors in its decision when assessing the safety and efficacy of the vaccines. EMA will also ensure that this information is transparent and accessible.

As pregnancy is often part of the exclusion criteria for medical trials, more data are needed to understand the safety implications for pregnant people. 

• How have the studies looked for potential side-effects of the vaccine?

Participants in the trials will be followed up for a minimum of 6 weeks. Most side-effects happen within 4-6 weeks of having a vaccine. The trials will last up to a year to better understand the level of longer-term protection and side-effects.

Once the vaccines are released, there will be a robust monitoring plan for managing the safety of the vaccine. All new data about the vaccines will be monitored and assessed on a rolling basis.  If there are concerns, then the conditions for the vaccine being available can be re-assessed. If the conditions are not met, then the vaccine can be withdrawn.

Other key messages:

• The EMA has been very clear that safety will not be compromised, and that transparency is of utmost importance. It is important that everyone has enough information about the vaccines so they can understand them and the development process.
• The safety requirements for COVID-19 are the same for any other vaccines and have not been lowered due to the pandemic.
• The vaccines have been able to be developed so quickly due to a number of factors, including the pooling of resources and the overlapping of research timelines. 
• Vaccines are only approved if overall benefits outweigh the risks.
• COVID-19 vaccine safety will be stronger with your participation – please report suspected side-effects.