Lens on COVID-19 Vaccine Developments: Pfizer & BioNTech Granted FDA Fast-track Designation and more


  • The unrelenting pressure from the coronavirus pandemic has made the development of a COVID-19 vaccine the top priority of governments and healthcare authorities around the globe.
  • Pfizer and BioNTech obtained FDA fast-track designation for two Investigational mRNA-based vaccine candidates for COVID-19.
  • The companies plan to commence Phase 2b/3 safety and efficacy clinical trial as early as July 2020.
  • Queensland University initiated a Phase 1 trial for its COVID-19 vaccine candidate in Australia.
  • Chinese vaccine developer CanSino Biologics to start Phase 3 trials of its vaccine candidate ‘Ad5-nCoV’.

The global efforts for developing a safe, effective, affordable, and readily available COVID-19 vaccine are going on in full swing, and researchers worldwide are working round-the-clock for the same. According to the World Health Organization (WHO), 23 vaccine candidates are under clinical evaluation, and 137 are under preclinical evaluation (as on 13 July 2020).

Globally, there have been over 12.88 million confirmed cases of COVID-19, including 568,573 fatalities, reported to WHO (as on 14 July 2020 at 8:10 AM CEST).

The US government had partnered with several vaccine developers to accelerate the development of their respective vaccine candidates, and are the healthcare players are moving into large-scale trials by the end of the summer. The Trump administration has provided funds for the development of COVID-19 vaccines under Operation Warp Speed (OWS) Program to fast track the clinical development.

In this article, we will discuss some recent COVID-19 vaccine developments:

FDA Fast-Track Designation Granted to Pfizer & BioNTech

On 13 June 2020, US-based Pfizer Inc (Nasdaq:PFE) and Germany biotech player BioNTech SE (Nasdaq:BNTX) disclosed that two of their four investigational vaccine candidates received fast-track designation from the US FDA (Food and Drug Administration).

The BNT162 mRNA-based vaccine program comprises four investigational vaccine candidates under development to combat COVID-19. The two most advanced vaccine candidates in the program are BNT162b1 & BNT162b2, which are currently under evaluation in Phase 1/2 clinical trial in the US and Germany.

Fast-track is a process designed to accelerate the development, and advance the review, of new drugs and vaccines that are meant to treat or prevent severe conditions and have the potential to address the unmet medical need.

Both the companies disclosed that fast track designation was granted based on preliminary information from Phase 1/2 clinical trials that are currently in progress along with animal immunogenicity studies.

On 1 July 2020, the two partners had released early positive data from the ongoing US Phase 1/2 clinical trial for the product candidate BNT162b1.

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Both BNT162b1 and BNT162b2 are nucleoside-modified RNAs which are formulated in lipid nanoparticles.

While BNT162b1 encodes an optimized SARS-CoV-2 receptor binding domain antigen, BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.

Phase 2b/3 safety and efficacy study might commence as early as July 2020

The vaccine development program, Project Lightspeed is based on the German biotech player’s proprietary mRNA-based technology platforms and well-aided by Pfizer’s worldwide vaccine development facilities and capabilities.

The vaccine candidates are under clinical development and are not yet approved for distribution anywhere across the world.

Subject to regulatory approval, the companies are anticipating beginning a Phase 2b/3 clinical trial as quickly as possible in July 2020. The companies are expecting to enrol nearly 30k volunteers.

Once the ongoing clinical studies are successful, and the BNT162 vaccine candidate will obtain regulatory authorization. The two companies presently anticipate manufacturing nearly 100 million doses by 2020 end and potentially over 1.2 billion doses by the end of 2021.

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About Pfizer Inc

One of the leading innovative biopharmaceutical players, Pfizer Inc (Nasdaq:PFE) is focused on the development of health care products, including innovative medicines and vaccines. The US-based healthcare behemoth collaborates with governments, local communities, and health care providers to offer support and expand access to dependable and reasonable health care worldwide.

About BioNTech SE

A next-generation immunotherapy company, BioNTech SE is a pioneer in the development of novel therapies for cancer as well as treatment for other severe disorders. Based on its expertise in mRNA-vaccine development along with in-house manufacturing capabilities, BioNTech, with its collaborators, is developing several mRNA-based vaccines.

Stock Information: On 13 July 2020, Pfizer shares climbed 4.08% to close the trading session at US$35.21 while BioNTech ADS soared by 10.55% to end at US$77.78 on Nasdaq.

Now let us shed some light on other recent COVID-19 vaccine developments:

Queensland University commenced Phase 1 trial of its COVID-19 vaccine

On 13 July 2020, the first clinical trials of the University of Queensland’s COVID-19 vaccine began in Australia with healthy volunteers being administered the first dose.

The University stated that Phase 1 clinical study would involve nearly 120 volunteers aged between 18 years and 55 years, with a proportion of participants to receive a placebo.

Notably, the Queensland University anticipates having preliminary findings from this first human trial after about 3-months. If all works well, the University will move as soon as possible to the next stage of its vaccine development.

The batch of COVID-19 vaccine for the first clinical trial was manufactured in a close partnership between the University and CSIRO’s advanced biologics manufacturing facility in Melbourne, with technical assistance from CSL Limited (ASX:CSL) and Cytiva.

If things proceed according to plan, CSL will swiftly advance manufacturing of tens of millions of doses and move the program into late-stage clinical trials, regulatory approval, large-scale manufacture, along with distribution.

For the COVID-19 vaccine development, the Queensland Government offered nearly A$10 million ‘Advance Queensland’ aid, the Federal Government provided A$5 million, and philanthropic and other donors have contributed over A$10 million.

DO READ: All that you need to know about COVID-19 Vaccine Development

CanSino Biologics to commence Phase 3 Clinical trial of its COVID-19 vaccine

Chinese vaccine developer CanSino Biologics is developing recombinant novel coronavirus vaccine candidate named Ad5-nCoV with Beijing Institute of Biotechnology (BIB). Currently, Ad5-nCoV is in Phase 2 clinical study in healthy volunteers aged above 18 years.

CanSino Biologics is determined to introduce its COVID-19 vaccine candidate as soon as possible with no compromise in its safety and quality.

According to Reuters, Qiu Dongxu, executive director and co-founder of CanSino, announced in an anti-viral drug development conference in Suzhou, China that the Company is in talks with Russia, Saudi Arabia, Chile, and Brazil to launch a Phase 3 clinical trial of its investigational COVID-19 vaccine.

With China managing the spread of the virus, the Company is looking at regions where it can enrol thousands of patients to conduct large-scale studies. CanSino aims to recruit ~40k participants for the study.

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