Pfizer and BioNTech’s COVID-19 vaccine shows promise in another early stage study

pharmafile | July 22, 2020 | News story | Research and Development BioNTech, COVID-19, Pfizer, Vaccine, pharma 

BioNTech and Pfizer have revealed more promising early data on their lipid nanoparticle formulated, nucleoside-modified messenger RNA vaccine candidate against COVID-19, known as BNT162b1.

A Germany-based Phase 1/2 non-randomised, non-placebo-controlled study studied the safety and efficacy of the vaccine in 60 healthy participants between the ages of 18 and 55.

Following a second dose in patients, the vaccine was shown to generate dose dependent levels of SARS-CoV-2-neutralising titers and receptor binding domain (RBD)-binding IgG concentrations. T cell responses were varied, with no clear dose level dependency identified between 1 µg to 50 µg.

Additionally, sera samples taken from vaccinated subjects “displayed broadly neutralizing activity in pseudovirus neutralisation assays across a panel of sixteen SARS-CoV-2 RBD variants. Upon reviewing the findings, Pfizer and BioNTech believe the vaccine is potentially safe and with manageable side-effects, after no withdrawals or serious adverse events occurred.

“It is encouraging that the data on BNT162b1 from the German study cohort are very much in line with what we have seen in the US study cohort,” commented Dr Özlem Türeci, Chief Medical Officer and Co-founder at BioNTech. “The preliminary data indicate that our mRNA-based vaccine was able to stimulate antibody as well as T-cell responses at remarkably low dose levels. We believe both may play an important role in achieving effective clearance of a pathogen such as SARS-CoV-2.”

 The trial data is currently undergoing peer review prior to potential publication. Combined with the data generated from its US counterpart, these findings will now be used to determine dosage levels and progress a vaccine candidate into global Phase 2b/3 studies.

In the event that a candidate proves successful, the two firms aim to manufacture up to 100 million doses by the end of this year, with a further 1.3 billion doses planned by the end of 2021.

Matt Fellows

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