Pfizer, BioNTech's Coronavirus Vaccine Candidates Get FDA's 'Fast Track' Status

Marco Green
July 13, 2020

The BNT162b1 and BNT162b2 formulations are the most advanced in the programme, now being evaluated in phase 1/2 clinical trials in the U.S. and Germany.

The fast-track designation facilitates the development and speeds up the review of new drugs and vaccines that have the potential to address an unmet medical need.

In premarket trading Monday, Pfizer shares rose 1.5% to $34.34, and BioNTech's ADRs were up 5.1% at $73.99.

Research into potential Covid-19 vaccines being developed by Pfizer and BioNTech has been granted so-called Fast Track designation by the US Food and Drug Administration, sending shares in both drug firms higher.

If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies said they expect to manufacture up to 100 million doses by the end of the year and potentially more than 1.2 billion doses by the end of 2021. These preliminary data, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial.

The Project Lightspeed programme is based on BioNTech's proprietary mRNA-based technology platforms and is supported by Pfizer's global vaccine development capabilities. That trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received.

Globally, of 19 experimental COVID-19 vaccines in human trials, only two are in final Phase III trials - one by China's Sinopharm and another by AstraZeneca and the University of Oxford.

The fast track comes after some initial USA results out earlier this month from an early clinical test of 45 patients that showed all of them who received 10 micrograms or 30 mcg of the mRNA vaccine candidate generated antibodies that were 1.8 times and 2.8 times higher, respectively, than the average of a group of patients who had confirmed prior infections, although it did come with side effects.

The coronavirus vaccine being jointly developed by Pfizer Inc. For more than 150 years, we have worked to make a difference for all who rely on us. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.

Other reports by Click Lancashire

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