October 7, 2020 -- The European Medicines Agency (EMA) has accepted rolling review of BioNTech and Pfizer's SARS-CoV-2 vaccine candidate BNT162b2 based on preclinical and clinical data.
During the process, both companies will continue to communicate with EMA about its results from its ongoing phase III study. To date, clinical data suggests that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2.
During the EMA's rolling review, data will be reviewed as it becomes available. Then, once the EMA Committee for Medicinal Products for Human Use (CHMP) decides there is sufficient data, the company can submit the complete application. The early review of data can help CHMP come to its decision quicker on whether the investigational medicine or vaccine should be authorized. Once the complete application is submitted, the EMA will determine if the product is granted marketing authorization.