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European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation in the European Union (EU) for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent COVID-19 in people from 16 years of age.

The human medicines committee (CHMP) at EMA has completed its rigorous evaluation of Comirnaty, concluding that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation. The results from the main trial (NCT04368728) on this vaccine showed that it has a 95% efficacy. Most side effects are mild to moderate in severity and are gone within a few days. They include pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever. This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns.

However, the safety and effectiveness of the vaccine will continue to be monitored as it is used across Europe, through the EU pharmacovigilance system. Companies are also required to provide monthly safety reports in addition to the regular updates required by the legislation and to conduct studies to monitor the safety and effectiveness of the vaccine as they are used by the public. Authorities will also conduct additional studies to monitor the vaccines.

These measures will allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory actions to protect public health if needed.

Comirnaty is not currently recommended for children below 16 years of age. However, EMA has agreed with the company on a paediatric investigation plan to trial the vaccine in children at a later stage.

As Comirnaty is recommended for a conditional marketing authorisation, the company that markets Comirnaty will continue to provide results from the main trial, which is ongoing for 2 years. This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromised people, children and pregnant women as well as whether it prevents asymptomatic cases.

The European Commission authorised Comirnaty against COVID-19 and the next step will be to ensure that the first doses will be delivered on 26 December, so that the vaccination programmes can start from 27 December across Europe.

This can be considered the first step forward in our fight against the pandemic!  Stay tuned for further updates!

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