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To
cope up with COVID-19 crisis, BNT162b1 and BNT162b2 vaccines have been granted
‘fast track’ label.
As on 20 July, 2020, two vaccines candidates- BNT162b1 and BNT162b2- both nucleoside-modified messenger RNA (modRNA) vaccines for COVID-19 by renowned Pharmaceutical Corporation and Biotechnology Company have been designated ‘Fast Track’ by the FDA.
The BNT162b1 encodes an optimized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein receptor binding domain (RBD) antigen, on the otherhand, BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen. The positive preliminary results from a phase 1/2 study assessing BNT162b1 were recently broadcasted by these companies. The vaccine candidate were found to have counteracting antibody responses like those observed in recovering human serology samples gathered from patients with definite SARS-CoV-2 infection, as per the early discoveries from the US trial. Similar trial data in Germany is anticipated in July. If all goes well following the regulatory approval, a phase 2b/3 trial comprising approximately 30,000 individuals, could initiate this July after a suitable dose level is established.
Also, as expected, Companies are most likely to manufacture up to 100 million doses by year 2020 end and perhaps >1.2 billion doses by year 2021 end.
FDA Fast-Tracks Two mRNA-Based COVID-19 Vaccine Candidates
Diana Ernst
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