BioNTech and Pfizer's COVID-19 vaccine candidate could seek regulatory approval for October

Pharmaceutical

BioNTech and Pfizer have unveiled additional information from a Phase I study of two of its COVID-19 vaccine candidates, in addition to their plans to possibly seek regulatory approval by this coming October.

During July, both BioNTech and Pfizer unveiled early positive data from their mRNA COVID-19 vaccine programme, which demonstrated that BNT162b1 generated promising dose-dependent immunogenicity. The companies then revealed that the vaccine candidate BNT162b2 had been selected for a Phase 3 clinical trial. In the recent data, both of the companies posted the results from all three-hundred and thirty-two participants tested with both of the mRNA-based candidates.

“BioNTech and Pfizer's COVID-19 vaccine candidate could seek regulatory approval for October.“

The data revealed that systemic events following administration of BNT162b1 weren't as mild as those experienced with BNT162b. Following the second dose of BNT162b2, only seventeen per cent of participants aged eighteen to fifty-five years old reported fever, in comparison to seventy-five per cent in the same age round in the BNT162b1 arm.

The researchers experimented a range of doses of the vaccines, but they have chosen to proceed with the thirty-microgram dose of BNT162b2 in late-stage trials.

Chief Executive Officer and co-founder, BioNTech, Ugur Sahin, stated: “It is important to us to continue sharing data and related information on our COVID-19 vaccine lead candidate. The favorable safety profile of BNT162b2 and the breadth of T cell responses we previously announced have supported our decision to select this candidate for the pivotal phase II/III study. As of today, we have already dosed more than eleven-thousand participants with BNT162b2 in that study.”

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