Summary of characteristics of Pfizer, Moderna and AstraZeneca products (EMA documents)

… 2 – Qualitative and quantitative composition 

[ AstraZeneca ] Produced in genetically modified human embryonic kidney (HEK) 293 cells and by recombinant DNA technology

4.4 – Immunocompromised individuals – Duration of protection

[ Pfizer ] The efficacy, safety and immunogenicity of the vaccine has not been assessed – The duration of protection afforded by the vaccine is unknown

[ Moderna ] The efficacy, safety and immunogenicity of the vaccine has not been assessed – The duration of protection afforded by the vaccine is unknown

[ AstraZeneca ] The efficacy, safety and immunogenicity of the vaccine has not been assessed – The duration of protection afforded by the vaccine is unknown

4.5 – Interaction with other medicinal products and other forms of interaction

[ Pfizer ] No interaction studies have been performed

[ Moderna ] No interaction studies have been performed

[ AstraZeneca ] No interaction studies have been performed

… 5.1 – Mechanism of action

[ Pfizer ] may contribute to protection against COVID-19

[ Moderna ] may contribute to protection against COVID-19

.. [ AstraZeneca ] may contribute to protection to COVID-19

… 5.3 – Genotoxicity/Carcinogenicity

[ Pfizer ] Neither genotoxicity nor carcinogenicity studies were performed

[ Moderna ] Carcinogenicity studies were not performed

[ AstraZeneca ] Neither genotoxicity nor carcinogenicity studies were performed

Annex II E – Specific obligation to complete post-authorisation measures for the conditional marketing authorisation

[ Pfizer ] to confirm the efficacy and safety … should submit the final Clinical Study Report: December 2023

[ Moderna ] to confirm the efficacy and safety … should submit the final Clinical Study Report: December 2022

[ AstraZeneca ] to confirm the efficacy and safety … should provide … final analysis from the pooled pivotal studies: 31 May 2022

          Pfizer – EMA

 

          Moderna – EMA

 

        AstraZeneca – EMA

 

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