Promising early immunogenicity data for Pfizer and BioNTech’s COVID vaccine candidate
pharmafile | July 3, 2020 | News story | Medical Communications, Research and Development | BioNTech, COVID-19, Pfizer, Vaccine
Pfizer and BioNTech have revealed new efficacy findings on the “most advanced” of four candidates being worked on as part of their BNT162 RNA-based COVID-19 vaccine programme known as Project Lightspeed, showing that it successfully generated immune response in healthy patients.
The candidate, known as BNT162b1 was found to generate effective immunogenicity dependent on dosing according to RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers, while being well-tolerated by patients.
The ongoing Phase 1/2 study evaluated the efficacy of the candidate in 45 healthy participants between the age of 18 and 55; 24 of them receiving two vaccination doses at 10 µg and 30 µg showed respective geometric mean concentrations of 4,813 and 27,872 units/ml after 28 days. The 12 patients receiving a single injection of 100 µg, showed an RBD-binding IgG GMC of 1,778 units/ml.
Dr Ugur Sahin, CEO and Co-founder of BioNTech, commented on the findings: “These preliminary data are encouraging in that they provide an initial signal that BNT162b1 targeting the RBD SARS-CoV-2 is able to produce neutralising antibody responses in humans at or above the levels observed in convalescent sera – and that it does so at relatively low dose levels. We look forward to providing further data updates on BNT162b1.”
The companies now plan to use these preliminary data to forge ahead to a global Phase 2/3 study. In the event the candidate proves successful, Pfizer and BioNTech also plan to produce up to 100 million doses by the end of the year, with an additional 1.2 billion doses planned for production in 2021.
“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings,” said Dr Kathrin U Jansen, Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency. We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible.”
Matt Fellows
Related Content
BioNet receives positive EMA opinion on new pertussis vaccine
BioNet has received a positive opinion from the Committee for Medicinal Products for Human Use …
Recipharm offers manufacturing support to vaccine trial from ImmBIO and iiCON
Recipharm, a contract development and manufacturing organisation (CDMO), has successfully manufactured PnuBioVax, a new protein-based …
COVID-19 vaccine eligibility creates challenges for UK pharmacies
Pharmacists across England have reported widespread confusion among patients attempting to book COVID-19 vaccination appointments …
