Pfizer: EMA starts rolling review of coronavirus vaccine

(CercleFinance.com) - Pfizer and its German partner BioNTech on Tuesday announced the initiation of a "rolling submission" to the European Medicines Agency (EMA) for their experimental vaccine against Covid-19.


A "rolling" review is one of the regulatory tools that the agency uses to speed up the assessment of a promising medicine or vaccine during a public health emergency.

The companies said that the EMA's decision to start the so-called "rolling review" of data follows encouraging preliminary results from pre-clinical and early clinical studies, which suggest that BNT162b2 triggers the production of neutralising antibodies and cells that target the virus.

"A combination of an antibody and T cell response is believed to be important in eliciting protection against viral infection and disease", Pfizer and BioNTech said in a statement.

The vaccine candidate is currently being evaluated in a global Phase 3 study ongoing at more than 120 clinical sites worldwide including the United States, Brazil, South Africa and Argentina.

To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

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