Paul-Ehrlich-Institut

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Eu­ro­pean Vari­a­tion Pro­ce­dure Be­gins for Boost­er Vac­ci­na­tion with the COVID-19 Vac­cine Comir­naty

On September 6, 2021, the European Medicines Agency (EMA) began reviewing the application for a variation of the license for the COVID-19 vaccine Comirnaty (BioNTech). The subject of the variation under consideration is the administration of a booster dose of the above vaccine. According to the application, the booster vaccination should take place no less than six months after administration of the second dose for persons aged 16 and over.

Comirnaty COVID-19 Vaccines (Source: M HAZWAN H/shutterstock.com)

The Committee for Medical Products for Human Use (CHMP) at the EMA will carry out an accelerated evaluation of the data presented by BioNTech, including the results of an ongoing clinical trial in which around 300 adults with healthy immune systems receive a booster dose around six months after the second dose.

Booster vaccinations are given to vaccinated individuals (i.e., people who have received basic immunisation) in order to maintain or restore the immune protection after it has worn off.

After reviewing the data, the Committee for Medicinal Products for Human Use (CHMP) will issue a recommendation on whether the variation and the corresponding amendment to the product information should be authorised by the European Commission. The result of this evaluation is expected in the next few weeks.

Aside from this, the CHMP is also evaluating data from the literature on the use of an additional third dose of an mRNA vaccine (Comirnaty or Spikevax) for basic immunisation in persons with severely weakened immune systems who may not have sufficient protection with the standard basic immunisation with two doses.

The EMA will provide information on the outcome of these CHMP evaluations in due course.

Background

While these assessments are ongoing, the EMA secretariat and the ECDC (European Center for Disease Prevention and Control) have announced their current position in relation to the need for additional and booster doses of COVID-19 vaccines in a separate communication. Although the EMA and the ECDC do not believe there is an urgent need for booster doses of the COVID-19 vaccine among the general population, the EMA is reviewing the current application to ensure that evidence exists to support additional doses if needed. Recommendations on whether and how COVID-19 booster vaccines should be administered is the responsibility of the National Immunization Technical Advisory Groups (NITAGs), such as the Standing Committee on Vaccination (Ständige Impfkommission, STIKO) in Germany.

Comirnaty is the COVID-19 mRNA vaccine developed by BioNTech/Pfizer, which is currently authorised for use in persons from 12 years of age. According to the legal interpretation by Paul-Ehrlich-Institut and the BMG, the booster vaccinations currently already offered in Germany do not conflict with the intended use of the vaccine according to the approval.

Updated: 10.09.2021