FDA Grants Fast Track Designation to Experimental COVID-19 Vaccines

Pharmacists might be administering COVID-19 vaccines somewhat sooner than they had feared. The FDA has granted Fast Track designation to two of four investigational candidates from Pfizer Inc. and BioNTech SE. Phase 2b/3 safety and efficacy studies could begin as early as this month. Here is more information.

NEW YORK – A potential vaccine for COVID-19 was granted Fast Track designation by the Food and Drug Administration and could be further tested in a large, global Phase 2b/3 safety and efficacy study as early as this month.

Pfizer Inc. and BioNTech SE 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 the FDA designation. Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need.

The companies note that the two investigational vaccine candidates, BNT162b1 and BNT162b2, are the two most advanced in their efforts and are currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.

Early data from the studies were released on the online preprint server medRxiv at the beginning of July and is concurrently undergoing scientific peer-review for potential publication.


The ongoing placebo-controlled, observer-blinded dose escalation study is being conducted among healthy adults, 18-55 years of age, randomized to receive two doses, separated by 21 days, of 10 μg, 30 μg, or 100 μg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.

Researchers report that local reactions and systemic events were dose-dependent, generally mild to moderate and transient. At the same time, they write, RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose; geometric mean neutralizing titers reached 1.8- to 2.8-fold that of a panel of COVID-19 convalescent human sera.

The BNT162 program is evaluating at least four experimental vaccines, each of which represent a specific combination of messenger RNA (mRNA) format and target antigen.

Subject to regulatory approval, the companies are expecting to begin a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects. If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the Pfizer and BioNTech SE say they plan to manufacture up to 100 million doses by the end of 2020 and possibly more than 1.2 billion doses by the end of 2021.

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