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BioNTech and Pfizer have dosed participants in the first cohort of a Phase I/II clinical trial of Covid-19 vaccine candidate BNT162 in Germany.
Dosing in the trial was commenced on 23 April and 12 participants have received the vaccine so far.
The companies also intend to trial BNT162 in the US following regulatory approval.
BioNTech said in a statement: “The trial is the first clinical trial of a Covid-19 vaccine candidate in Germany. Pfizer and BioNTech plan to initiate trials for BNT162 in the US upon regulatory approval, which is expected shortly.”
Earlier this month, BioNTech and Pfizer secured approval from the German regulatory authority, Paul-Ehrlich-Institut, for the Phase I/II clinical trial of BioNTech’s BNT162.
The trial’s dose escalation part will enrol around 200 healthy participants aged 18 to 55. Participants will be administered with a dose range of 1µg to 100µg.
BioNTech and Pfizer aim to potentially establish the optimal dose for further studies. The study will also assess the vaccine candidate’s safety and immunogenicity.
The trial will also study the impact of repeated vaccination after a prime injection for three of BioNTech’s Covid-19-focused vaccine candidates, which are made of uridine containing mRNA (uRNA) or nucleoside modified mRNA (modRNA).
A fourth vaccine candidate containing self-amplifying mRNA (saRNA) will be assessed after a single dose.
The second part of the Phase I/II trial will enrol patients at a higher risk of severe Covid-19 infection.
BNT162 is being jointly developed by BioNTech and Pfizer.
BioNTech will be responsible for the clinical supply of the vaccine from its mRNA manufacturing facilities in Europe during the clinical development stage.
The company is also working with Fosun Pharma to develop BNT162 in China, with plans to conduct clinical trials in the country.