Pfizer: accelerated procedure for Covid vaccine
(CercleFinance.com) - Pfizer and its German partner BioNTech announced on Monday that the US Food and Drug Administration (FDA) has granted a fast-track review to their Covid-19 vaccine project.
According to Pfizer and BioNTech, the FDA procedure concerns the BNT162b1 and BNT162b2 vaccines, i.e. the two most advanced RNA compounds in their program, which includes four in all.
Both these vaccines, which are currently undergoing phase 1/2 clinical trials in the United States and Germany, could enter phase 2b/3 by the end of this month in a study likely to include up to 30,000 people, the companies say.
According to statements made by BioNTech to the Wall Street Journal this weekend, a marketing dossier could be submitted to health authorities by the end of the year.
Pfizer and BioNTech say that they are already aiming to produce 100 million doses of vaccine by the end of the year and plan to manufacture 1.2 billion doses by the end of 2021.
The FDA's "fast-track" system is expected to reduce the time it takes to obtain approval for clinical trials and provide faster access to treatment for patients.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
According to Pfizer and BioNTech, the FDA procedure concerns the BNT162b1 and BNT162b2 vaccines, i.e. the two most advanced RNA compounds in their program, which includes four in all.
Both these vaccines, which are currently undergoing phase 1/2 clinical trials in the United States and Germany, could enter phase 2b/3 by the end of this month in a study likely to include up to 30,000 people, the companies say.
According to statements made by BioNTech to the Wall Street Journal this weekend, a marketing dossier could be submitted to health authorities by the end of the year.
Pfizer and BioNTech say that they are already aiming to produce 100 million doses of vaccine by the end of the year and plan to manufacture 1.2 billion doses by the end of 2021.
The FDA's "fast-track" system is expected to reduce the time it takes to obtain approval for clinical trials and provide faster access to treatment for patients.
Copyright (c) 2020 CercleFinance.com. All rights reserved.