EU medicines agency: COVID vaccine side effects still being monitored

European Medicines Agency (EMA) chief Emer Cooke assured that COVID-19 vaccines are safe and side effects are still being monitored, in response to criticism from vaccine-sceptic MEPs.

“I am proud of the role that EMA has played in helping to ensure that all 27 EU countries could receive safe, effective, and high-quality vaccines,” said the executive director of the EU agency in an exchange of views with lawmakers in the European Parliament on Monday (27 March).

As the EMA was the EU agency in charge of evaluating vaccines in order to give them EU marketing authorisation, many of the questions from MEPs were about the development, distribution, and side effects of the vaccines.

“We saw an unprecedented surge in requests for information and we had to adapt to these new demands and deliver reliable, authoritative information to all our stakeholders,” said Cooke.

Since the start of the pandemic in 2020, the EMA has published 50 monthly reports with figures on how many EU citizens got the jab and if they had side effects, as well as the number of deaths after receiving the dose.

On the other side, vaccine manufacturers in Europe need to provide monthly safety reports to the EMA – while with other types of vaccines, the EU agency asks for reports after six months of usage.

While COVID-19 vaccines were developed and produced at unprecedented speed, Cooke emphasised that this did not lead to a compromise on safety requirements.

“At the time of the authorisation of the first COVID-19 mRNA vaccines they had been tested in clinical trials with 15,000 to 20,000 subjects,” she stressed, adding that this is a number somewhere between five and ten times larger than most vaccine trials.

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The exchange of views culminated in a heated debate on the side effects of vaccines and what the EMA is doing to monitor them now that the majority of the European population is vaccinated.

In particular, lawmakers from the far-right ID group accused the EMA of keeping information about the side effects and deaths caused by the vaccines.

Christine Anderson, German far-right MEP asked Cooke how many deaths have been reported to EMA with regard to mRNA injections – a type of vaccine such as the ones developed by Pfizer or Moderna which teaches cells how to make a protein that triggers an immune response, in this case to COVID-19.

“If you can’t provide the numbers off the top of your head, I would have to conclude that you simply don’t care or you’re working for big pharmaceutical companies in Europe,” she added.

Socialist MEP Kathleen Van Brempt, chair of the special committee on COVID-19 (COVI) at the European Parliament, asked EMA’s Cooke to disregard this affirmation, as “people don’t have all these numbers from the top of their head, that is not possible”.

However, Cooke ended the meeting promising that EMA will send all the reports and studies that MEPs are asking for, insisting that the agency will keep working and monitoring the side effects of vaccines.

“We keep doing assessments with pharmacovigilance specialists who are used to working with this data. They’re trying to evaluate if there are problems and what we can do about it,” she concluded.

[Edited by Gerardo Fortuna/Nathalie Weatherald]

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