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Pfizer and BioNTech Vaccine Candidates Achieve FDA Fast Track Status

FILE PHOTO. The Pfizer logo is seen on a monitor of the New York Stock Exchange in the United States. December 5, 2017. REUTERS / Lucas Jackson.

Jul 13 (Reuters) – Two experimental coronavirus vaccines jointly developed by German biotech firm BioNTech and US pharmaceutical giant Pfizer received the “fast track” designation by the US regulatory agency, the firms said Monday.

The candidates, BNT162b1 and BNT162b2, are the most advanced of at least four vaccines evaluated by companies in trials in the United States and Germany.

Pfizer’s shares were up about 2% and BioNTech’s US-listed stocks were up about 6% before the markets opened.

Earlier in the month, the firms said that BNT162b1 showed potential against the virus and was found to be well tolerated in the early stages of their trials.

Initial data from the German BNT162b1 trial is expected to be released in July, the companies said.

If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the firms said they hope to be able to make up to 100 million doses by the end of the year, and potentially more than 1.2 billion by the end of 2021.

The companies said they hope to start a large trial with up to 30,000 participants by the end of the month at the earliest, if they receive regulatory approval.

The “fast track” status of the Food and Drug Administration (FDA) guarantees an acceleration of the review of new drugs that show potential to deal with unpublished medical needs.

Report of Manas Mishra and Manojna Maddipatla in Bengaluru; edited in Spanish by Marion Giraldo and Carlos Serrano

Our Standards:The Thomson Reuters Principles

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