Pfizer and BioNTech Initiate Rolling Submission to EMA for BNT162b2 COVID-19 Vaccine

On October 6, Pfizer and BioNTech announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, their flagship COVID-19 vaccine developed in collaboration. The EMA’s acceptance of the rolling review was based on positive preliminary results from preclinical and early-phase clinical studies in adults, which demonstrated that BNT162b2 induces neutralizing antibodies as well as a TH1-skewed response of CD4+ and CD8+ T cells targeting SARS-CoV-2. The combination of antibody and T-cell responses is considered important in eliciting protective immunity against viral infection and disease. BioNTech and Pfizer plan to collaborate with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process, thereby facilitating the final Marketing Authorization Application (MAA).

As part of the rolling review, the CHMP has begun evaluating data generated from preclinical trials. Once vaccine efficacy and safety are demonstrated, and the EMA confirms that the submitted data are sufficient, a formal Marketing Authorization Application (MAA) can be completed following the rolling review procedure. By reviewing data as they become available, the CHMP can reach its opinion on whether the investigational drug or vaccine should be approved at an earlier stage.

The BNT162b2 candidate vaccine is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. It encodes an optimized full-length SARS-CoV-2 spike glycoprotein (S), which is the target of virus-neutralizing antibodies. The candidate vaccine is currently being evaluated in a global Phase 3 study conducted at more than 120 clinical centers worldwide, including sites in 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 the second dose.

Preliminary data from the Phase 1/2 portion of the study indicated that BNT162b2 was well tolerated across all age groups, with mild to moderate adverse events observed. The candidate vaccine demonstrated dose-dependent immunogenicity, as assessed by receptor-binding domain (RBD)-binding IgG concentrations and SARS-CoV-2 neutralizing titers. Furthermore, BNT162b2 induced T-cell recognition of a broader range of epitopes within the SARS-CoV-2 spike protein in subjects and simultaneously elicited high-magnitude CD4+ and CD8+ T-cell responses. These responses were characterized by a TH1-dominant profile against the RBD, as well as responses against the remaining full-length spike glycoprotein.

References:

[1] BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine Candidate BNT162b2. Retrieved 2020-10-06, from http://www.globenewswire.com/news-release/2020/10/06/2104060/0/en/BioNTech-and-Pfizer-Initiate-Rolling-Submission-to-European-Medicines-Agency-for-SARS-CoV-2-Vaccine-Candidate-BNT162b2.html

Source: Jike News

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