Pfizer and BioNTech have reported positive preliminary results from the ongoing Phase I/II clinical trial of BNT162b1, a potential Covid-19 vaccine.
BNT162b1 is the most advanced of the four Covid-19 vaccine candidates being assessed as part of Pfizer and BioNTech’s BNT162 mRNA-based vaccine programme.
A nucleoside-modified messenger RNA (modRNA) candidate, BNT162b1 encodes an optimised SARS-CoV-2 receptor binding domain (RBD) antigen.
The randomised, placebo-controlled, observer-blinded Phase I/II trial is being performed in the US to assess the safety, tolerability and immunogenicity of escalating dose levels of BNT162b1.
For the initial part of the study, 45 healthy adults aged 18 to 55 years were enroled.
Preliminary data was obtained from 24 participants who were given two 10µg and 30µg injections, 12 subjects who had a single 100µg injection and nine subjects who received two doses of placebo.
The results showed that the vaccine candidate could be given at a dose that was well tolerated and produced dose dependent immunogenicity.
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