Pfizer, BioNTech Gain FDA Fast Track for COVID-19 Vaccine Candidates

Pfizer and BioNTech were recently granted FDA Fast Track designation for two of the companies’ four investigational COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program, according to a recent press release.

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The two candidates, BNT162b1 and BNT162b3 are the two most advanced candidates from the program being evaluated in ongoing Phase 1/2 clinical studies in the US and Germany.

“BNT162b1 and BNT162b2 are both nucleoside modified RNAs, formulated in lipid nanoparticles. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen,” the release said.  

Fast Track is a process to facilitate the development and expedite the review of new drugs and vaccines to treat or prevent serious conditions that have the potential to address an unmet medical need, FDA said in a statement.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, senior vice president, global regulatory affairs, Pfizer, said in the press release.

“We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”

FDA granted the fast track designation based on preliminary data from Phase 1/2 studies that are currently ongoing in the US and Germany.

Last week, Pfizer and BioNTech released positive preliminary data from the Phase 1/2 study of BNT162b1.

The data found that the investigational vaccine candidate could be administered in a dose that was well tolerated and generated dose-dependent immunogenicity.

According to Pfizer, the highest amount of antibodies present were found seven days after the second dose of 10 µg or 30 µg on Day 28 after vaccination. The neutralizing geometric mean concentration (GMC), or average antibody concentration, were 168 and 267 for the 10 µg and 30 µg dose levels, respectively.

At Day 21 after a single injection, the 12 subjects who received 100 µg had an RBD-binding IgG GMC of 1,778 units and a neutralizing GMT of 33.

At the 10 µg and 30 µg dose levels, adverse reactions included low-grade fever and were more common after the second dose than the first.

“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” said Özlem Türeci, chief medical officer at BioNTech.

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

In the near future, Pfizer and BioNTech will select among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial, Pfizer said in a separate announcement.

The trial, which will include nearly 30,000 healthy adults, is expected to begin later this month.

If the ongoing studies are successful and the vaccine candidate receives regulatory approval, BioNTech and Pfizer said they will manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

“We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency. We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible,” Pfizer said.