![]() ![]() The linked documents are subject to change, so we have provided a link to the overview page. Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine. Re-Open EU: website linking to the list of vaccines in use around the world that are not authorised in the EU and linking to a document providing a more detailed overview of vaccines administered by third countries that most EU Member States/EEA countries consider to be corresponding to vaccines authorised in the EU. Extraordinary efforts by scientists, regulators, and developers enabled the European Medicines Agency (EMA) to recommend the first EU conditional marketing authorisation (CMA) for the BioNTech COVID-19 mRNA vaccine (nucleoside-modified) BNT162b2 (Comirnaty) some 9 months after the COVID-19 pandemic was declared.1 As of April 2021, six viral vector vaccines, four COVID-19 vaccines and two Ebola vaccines, have been authorized. ![]() The safety updates summarise the data that have become available since the vaccine's authorisation. EMA releases a monthly update for each authorised COVID-19 vaccine. The adapted vaccines are based on the original strain of the virus and the newer Omicron sub-variants, and therefore are also referred to as bivalent vaccines. Overview Vaccines in Use around the World A viral vector vaccine is a vaccine that uses a viral vector to deliver genetic material ( DNA) that can be transcribed by the recipient's host cells as mRNA coding for a desired protein, or antigen, to elicit an immune response. The European Medicines Agency publishes safety updates for the COVID-19 vaccines authorised in the EU. In December 2022 EMA’s Emergency Task Force concluded that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants may be used for primary vaccination.
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