Europe Considers 3rd COVID-19 Vaccination for Teenagers
The European Medicines Agency (EMA) confirmed on September 6, 2021, it has started evaluating an application for the use of a booster (3rd) dose of the mRNA Comirnaty (Pfizer - BioNTech) vaccine to be given 6 months after the second dose in people aged 16 years and older.
The EMA’s committee will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, BioNTech Manufacturing GmbH, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster (3rd) dose approximately 6 months after the second dose.
While these evaluations are ongoing, the EMA and the European Centre for Disease Prevention and Control (ECDC) have highlighted their current position on September 2nd regarding the need for additional and booster doses of COVID-19 vaccines in a separate communication.
'It is important to distinguish between booster doses for people with normal immune systems and additional doses for those with weakened immune systems.'
Although the EMA and ECDC do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, the EMA is evaluating the present application to ensure evidence is available to support further doses as necessary.
The European Medicines Agency is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. An independent Management Board governs EMA.