Pfizer, BioNTech's coronavirus vaccine candidates get FDA's 'fast track' status

Pfizer, BioNTech's coronavirus vaccine candidates get FDA's 'fast track' status

Pfizer, BioNTech's coronavirus vaccine candidates get FDA's 'fast track' status

Pfizer Inc. and BioNTech SE have announced that two of the companies' four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).

The companies said the candidates, BNT162b1 and BNT 162b2, are the most advanced among the BNT162 program that is in early clinical studies in the USA and Germany. In early July, BNT162b1 showed positive early results in a human trial in the US.

Fast Track is a process created to facilitate the development, and expedite the review, of new drugs and vaccines to treat or prevent serious conditions with an unmet medical need. BNT162b1 and BNT162b2 are both nucleoside-modified RNAs formulated in lipid nanoparticles.

The companies expect early data from the German study of BNT162b1 to be released this month.

There are no approved vaccines for COVID-19, and the United States and other countries have poured billions into their development as they seek to secure a safe and effective vaccine.

Pfizer called the results encouraging because the vaccine succeeded in activating antibody responses at least as robust as convalescent sera - the antibody collected from patients who have recovered from COVID-19.

"We glance ahead to proceed working carefully with the FDA all through the scientific growth of this program, Mission Lightspeed, to consider the security and efficacy of those vaccine candidates", Peter Honig, Pfizer's senior vp of world regulatory affair, stated in a press release.

Researchers earlier this month said Pfizer and BioNTech's vaccine candidate showed promising signs of working in an early-stage study.

The companies said last month they're preparing to produce millions of vaccine doses this year and hundreds of millions in 2021. They are due to begin much larger trials with 30,000 people taking part, pending approval.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Along with the development and manufacture of health care products, including medicines, Pfizer has a well-established footprint in vaccines. We routinely post information that may be important to investors on our website at Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline.

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