Pfizer and BioNTech’s COVID-19 Vaccine Could Be Ready for Regulatory Approval by Year End

(New York, NY, USA) and Biopharmaceutical New Technologies (BioNTech Mainz, Germany) is expected to be ready for regulatory approval by this year end.

BioNTech SE co-founder and CEO Dr. Ugur Sahin told The Wall Street Journal (WSJ) that several hundred million doses of the vaccine could be produced even before its approval, and over one billion doses would be produced by 2021 end. The companies had recently announced positive preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2.

The BNT162 program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target antigen. According to preliminary clinical data for the nucleoside-modified messenger RNA (modRNA) candidate, BNT162b1, which encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen, BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers.

The ongoing US Phase 1/2 randomized, placebo-controlled, observer-blinded study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1. These preliminary data, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial. That trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received.

If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021. Mass vaccinations could start immediately in the US, Europe and elsewhere, depending upon countries’ logistical capacities as well as popular acceptance, Dr. Sahin told WSJ. However, Dr. Sahin warned that the coronavirus had become so widespread that it would take about 10 years before humanity achieved sufficient immunity to the disease, even if several companies launch a vaccine at the same time. “I assume that we will only be done with this virus when more than 90% of the global population will get immunity, either through infection or through a vaccine,” he told WSJ in a telephone interview.

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Biopharmaceutical New Technologies