Pfizer & BioNTech’s COVID-19 Vaccine Receives FDA’s Fast Track Designation

By Judy Ya-Hsuan Lin

The duo’s COVID-19 vaccine candidate is anticipated to obtain regulatory approval by the end of 2020 with approximately 100 million doses ready for immediate use and potentially more than 1.2 billion doses by the end of 2021.

Pfizer and BioNTech demonstrated their mRNA COVID-19 vaccine candidates, BNT162b1 and BNT162b2, can produce nearly double to triple virus-killing antibodies in healthy individuals and COVID-19 survivors. The two vaccine candidates have now bagged Fast Track designation from the USFDA sparking elation for both companies. Peter Honig, Senior Vice President of Global Regulatory Affairs at Pfizer, and Ozlem Tureci, Chief Medical Officer at BioNTech, expressed their joy in receiving the status.

Shares of both companies jumped up nearly 5% on the New York Stock Exchange and more than 15% on the Nasdaq, respectively, on July 13th. Their nearest competitor is Moderna’s, mRNA-1273, an mRNA vaccine candidate whose Phase 3 trial will commence this month. However, according to Canaccord Genuity analyst Arlinda Lee, Pfizer and BioNTech announced that they expect more data from these candidates, and BioNTech itself anticipates producing more clinical proof with eight other cancer drug candidates in the pipeline.

 

Project Lightspeed

BNT162b1 and BNT162b2, are two of the four investigational candidates under the mRNA-based vaccine program, Project Lightspeed, which integrates Pfizer’s global vaccine development capabilities and BioNTech’s proprietary mRNA-based technology platforms to help protect against COVID-19. 

Each of the four candidates is a unique combination of mRNA and target antigen. Both BNT162b1 and BNT162b2 are nucleoside modified RNAs, formulated in lipid nanoparticles encoding an optimized SARS-CoV-2 receptor-binding domain antigen and full-length spike protein antigen, respectively.

 

Clinical Results

Earlier in July, testing showed that BNT162b produced 1.8 to 2.7 times the level of neutralizing antibodies in 45 healthy volunteers than the recovered COVID-19 patients after a 28-day trial. Healthy volunteers aged 18 to 55 were randomized at 10 mg, 30 mg or 100mg, and vaccinated with two doses that were 21 days apart.

Despite the side effects that accompanied treatment, Fast Track designation was granted based on encouraging preliminary data from the ongoing Phase 1/2 trials and animal immunogenicity studies. Subject to regulatory approval, Pfizer and BioNTech are planning to enroll 30,000 subjects for a Phase 2b/3 trial later this month.

Related Article: Novavax to Deliver 100 Million COVID-19 Vaccine Doses by January 2021

References
  1. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two

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