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Parliamentary questions
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19 November 2020
P-005248/2020(ASW)
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: P-005248/2020

The marketing authorisation of COVID-19 vaccines are subject to the same EU legal requirements on safety and efficacy as any other medicine. These requirements will not be lowered in the context of the pandemic.

Clinical trials in the EU, including those for COVID-19 vaccines, are authorised and managed by the national competent authorities and ethics committees to ensure participants’ safety, rights and data robustness. Clinical trials, including the comparator and its safety, have been assessed by the countries in which they are authorised. The European Medicines Agency (EMA) has no decision-making role in the approval and monitoring of clinical trials.

However, the use of a different vaccine as comparator is acceptable according to EMA guidance(1) and has been used in many cases when justified. The meningitis Nimenrix vaccine has been authorised in the EU via the centralised procedure.

In their marketing authorisation application, COVID-19 vaccine developers need to submit clinical trial data to EMA with appropriate justification to their scientific approach and the validity of the data. EMA then carries out a thorough assessment to conclude on whether the vaccine is safe, efficacious and of good quality.

In large clinical trials, it is expected that illnesses will occur by chance amongst trial participants. Therefore, halting a trial until a potential safety issue is investigated is standard practice. Restarting a trial following a temporary halt for safety reasons is assessed and authorised by the national authorities.

(1)https://www.ema.europa.eu/en/clinical-evaluation-new-vaccines
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