FDA Gives ‘Fast Track’ Status To Pfizer, BioNTech’s COVID-19 Vaccine Candidates

Earlier the study described the preliminary clinical data for the candidate vaccine - nucleoside-modified messenger RNA (modRNA), BNT162b1.

The American pharmaceutical giant Pfizer Inc. and the European biotechnology company BioNTech SE have said that two of their experimental COVID-19 vaccine candidates have got “fast track” status from the Food and Drug Administration (FDA). The ‘fast track’ status is designed to speed up the regulatory review process of the new vaccines that have shown good results during trials.

Earlier the study described the preliminary clinical data for the candidate vaccine – nucleoside-modified messenger RNA (modRNA), BNT162b1.

It said the amount of antibodies produced in participants after they received two shots of the vaccine candidate was greater than that reported in patients receiving convalescent plasma from recovered COVID-19 patients.

Researchers, including those from New York University in the US, who were involved in the study, said the candidate vaccine enables human cells to produce an optimised version of the receptor binding domain (RBD) antigen — a part of the spike (S) protein of SARS-CoV-2 which it uses to gain entry into human cells.

“Robust immunogenicity was observed after vaccination with BNT162b1,” the scientists noted in the study. They said the program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target component of the novel coronavirus, SARS-CoV-2.

Based on the study’s findings, they said BNT162b1 could be administered in a quantity that was well tolerated, potentially generating a dose dependent production of immune system molecules in the patients.

The research noted that patients treated with the vaccine candidate produced nearly 1.8 to 2.8 fold greater levels of RBD-binding antibodies that could neutralise SARS-CoV-2.

“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,” Kathrin U. Jansen, study co-author and Senior Vice President and Head of Vaccine Research & Development, Pfizer, had said.

Facebook Comments