BioNTech/Pfizer has submitted a rolling application for the COVID-19 vaccine to the European Union.

On October 6, Pfizer/BioNTech announced that it had submitted a rolling application for COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA), which has been processed by the EMA and initiated by the Human Medicines Commission (CHMP).
, the EMA announced on October 1st that it had launched a rolling review of astrazenecon/Oxford University's COVID-19 vaccine, AZD1222.
Rolling applications and rolling reviews allow applicants to submit some of the data they have already obtained for review by regulators while clinical trials are still in progress, instead of having to submit all the efficacy and safety data, as is the case with traditional applications for listing, to speed up the approval process for clinically in-need drugs and vaccines.
CHMP has begun reviewing preclinical data for BNT162b2.
Pfizer/BioNTech will then have to submit evidence to the EMA to demonstrate the efficacy and safety of the BNT162b2 vaccine, and Pfizer/BioNTech will not complete the official listing application for BNT162b2 until the EMA confirms that the data submitted is sufficient.
BNT162b2 vaccine is based on BioNTech's proprietary mRNA technology, and Pfizer supports global vaccine development and production capacity.
BNT162b2 vaccine contains an optimized SARS-CoV-2 full-length prickly glycosin, which is the target of virus-in-the-virus antibodies that triggers the production of meso-antibodies as well as CD4 plus CD8-plus T cells with TH-1 advantages.
BNT162b2 vaccine is currently being tested in Phase III in more than 120 centres around the world, including countries such as the United States, Brazil, South Africa and Argentina, and has been included in a group of approximately 37,000 subjects, of whom more than 28,000 have completed the second dose of the vaccine.
preliminary data from the Phase I/II study of the BNT162b2 vaccine showed good tolerance and mild to moderate adverse events in all age groups.
the detection of IgG concentrations in the binding domain binding set, as well as THES-CoV-2 neutral and titration-detecting vaccines can produce dose-dependent immunogenicity.
addition, subjects immunized by BNT162b2 had T-cells in their bodies that could identify more of the prototypic proteins of the SARS-CoV-2 virus.
BNT162b2 can induce higher levels of CD4 plus and CD8 plus T cell response.
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