The COVID-19 vaccine candidate known as BNT162b2 may be getting closer to registration (e.g. approval) as the European Medicines Agency (EMA) has accepted the initiation of a rolling submission from partners Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX), the original developer of the RNA-based vaccine program. The EMA decision was made possible thanks to encouraging preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. In summary, because the combination of antibody and T cell response is believed to be important in eliciting protection against viral infection and disease, EMA considered and accepted this approach to reviewing the submission. Now the two companies, Pfizer and BioNTech, will engage with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate the final Marketing Authorization Application (MAA). CHMP is now analytically diving into this preclinical clinical trials data. The recent BioNTech press release notes that a formal MAA submission could be finalized subsequent to the rolling review process, of course pending demonstration of efficacy and safety of the product. EMA applies stringent standards for quality, safety and efficacy—similar to the U.S. Food and Drug Administration (FDA) long considered the Gold Standard in this area.
TrialSite breaks down this promising news.
What is EMA’s Rolling Review and Why is this News Important?
In a typical EMA submission for marketing authorization of a drug, for example, a company must combine in one massive regulatory submission package all data on an investigational medicine’s efficacy, safety and quality and all required documents must be submitted at the start of the evaluation in a complete application for marketing authorization. This represents a huge undertaking.
Now with the rolling review, EMA’s CHMP reviews the data as they become available for ongoing studies, before a complete application is submitted. Once the CHMP decides that sufficient data is available, the complete application should be submitted by the company. In this way CHMP can reach an opinion sooner on whether or not the investigational medicine or vaccine should be authorized. After a positive opinion, if adopted by the CHMP, it is the European Commission’s role to grant a Marketing Authorization.
Bottom line: this process can save time and money, and given pandemic conditions, makes complete sense.
What are some Key Data Findings Thus Far?
Preliminary data for the Phase 1/2 segments of the study demonstrate the experimental vaccine overall is well tolerated with mild to moderate adverse events in all age groups. The vaccine candidate generated dose level-dependent immunogenicity, as measured by receptor binding domain (RBD)-binding IgC concentrations and SARS-CoV-2 neutralizing titers. BNT162b2-vaccinated human participants display overall a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 spike antigen, and the experimental vaccine evidences a concurrent induction of high magnitude CD4+ and CD8+ T cell responses which were TH-1 dominant against the RBD and the remainder of the full spike glycoprotein.
BioNTech shares in its press release a link to a more comprehensive overview of the previously released data. See the link.
What are the Implications?
Well the most important one is that if CHMP continues to identify positive data sets and all else goes well, the actual registration and marketing authorization of the BNT162b2 vaccine for COVID-19 could occur sooner in Europe.
What is BNT162b2?
Based on BioNTech’s proprietary mRNA technology, BNT162b2 is also supported by Pfizer’s global vaccine development and manufacturing capabilities. The candidate encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is a target of virus neutralizing antibodies. For more, TrialSite encourages readers to visit our favorite vaccine tracking site Precision Vaccinations. For more on the BioNTech mRNA-based approach to a COVID-19 vaccine, see the link to their website. BNT162b2 competes with other mRNA-based COVID-19 vaccines such as the one from Moderna (mRNA-1273) and another German venture called Curevac.
Is the Candidate in Phase 3 (the final stage) Clinical Trials?
Yes. BNT162b2 is now the center of a global investigation involving over 120 clinical trial sites worldwide, including the United States, Brazil, South Africa and Argentina. To date, the trial has enrolled approximately 37,000 participants with over 28,000 having already received a second vaccination. For an overview of the clinical trial (NCT04368728), see the link.
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