European Medicines Agency examines request for 3rd dose for Pfizer-BionTech

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The European Union (EU) medicines regulator, the European Medicines Agency (EMA), has started to assess the demand for the third dose of Pfizer-BionTech’s Kovid-19 vaccine to be given as a booster dose to people over 16 years old. .

In the statement made by the EMA, it was reported that 6 months after the second dose of vaccine, a request was made for the administration of the third dose to be used as a supplement, and the evaluation of this was begin.

Recalling that booster doses are given to people vaccinated to restore protection in cases where protection is reduced, the statement said that an expedited assessment will be carried out with data provided by the vaccine manufacturer, and that A clinical study will be used in the evaluation with the participation of 300 adults who received the third supplemental dose 6 months after the second.

The EMA said the outcome of the assessment could be announced in the coming weeks.

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It was noted that the EMA also reviewed data on the administration of the third dose to people with very weak immune systems.

The Kovid-19 vaccine, developed by Pfizer-BioNTech and dubbed “Comirnaty”, received EU approval at the end of 2020. The vaccine is given to people over 12 years of age in EU countries.

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