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Summary

• As per the WHO, 163 investigational vaccines are currently being evaluated worldwide. 23 candidates are in the clinical stage, and the remaining 140 are under pre-clinical development.
• Moderna’s Phase 1 interim analysis shows that it is on the right track with its vaccine ‘mRNA-1273’.
• The US FDA granted Fast-Track Designation to Pfizer and BioNTech for BNT162b1 and BNT162b2.
• Cadila Healthcare (Zydus) commenced Phase 1 trial of its vaccine ‘ZyCoV-D’.
• The University of Queensland initiated Phase 1 clinical trial of its COVID-19 vaccine in Australia.

Thousands of scientists worldwide are working on more than 160 investigational vaccine candidates, and so far, none of them has been approved for use.

The surge in COVID-19 cases has made the availability of a vaccine the need of the hour. Healthcare companies across the globe are burning their midnight oil to find a safe and effective vaccine. Some biotech companies have completed the initial phases of the clinical trial and have moved into late-stage studies, raising the hopes of millions worldwide. In the US, the Trump administration is providing funds under the Operation Warp Speed (OWS) program to the vaccine developers for accelerating the development.

As per the draft landscape provided by the World Health Organization on 15 July, 163 investigational vaccines are being assessed across several platforms. Out of the candidates, 23 are under clinical evaluation, while 140 candidate vaccines are under pre-clinical evaluation.

To look at our previous coverage on vaccine candidates under clinical evaluation, click here.

In this 3-part series, we will highlight the companies/institutions engaged in COVID-19 vaccine development as per the WHO Draft Landscape (15 July 2020). We will focus on the recent updates of their respective vaccine candidates and the current stage of development.

Let us look at some of the key highlights and the 50 most talked about vaccine candidates (clinical and pre-clinical stage):

Moderna’s Phase 1 results show its COVID-19 vaccine ‘mRNA-1273’ is on the right track

On 14 July 2020, Moderna Inc (Nasdaq:MRNA) announced the publication of an interim analysis of the Phase 1 clinical study of mRNA-1273 in The New England Journal of Medicine. The evaluation assessed a two-dose vaccination program of mRNA-1273 given 28 days apart across three dose levels (25, 100, 250 µg) in 45 healthy volunteers aged between 18 and 55 years.

mRNA-1273 was found to be safe and well-tolerated. Moderna has an ongoing Phase 2 study and anticipates beginning a Phase 3 clinical trial in ~30k participants on 27 July 2020.

Pfizer & BioNTech Received FDA Fast Track Designation

On 13 July 2020, Pfizer Inc (Nasdaq:PFE) and BioNTech SE (Nasdaq:BNTX) revealed that the FDA had granted fast-track designation to two of the four investigational vaccine candidates. The two most advanced vaccine candidates of BNT162 program are BNT162b1 and BNT162b2, currently under evaluation in Phase 1/2 clinical trial in the US and Germany.

The fast-track designation was granted based on initial information from Phase 1/2 clinical studies along with animal immunogenicity studies.

Depending on regulatory approval, Phase 2b/3 clinical trials are expected to begin around July-end with up to 30k participants.

Zydus Commences Human Dosing of its COVID-19 vaccine ‘ZyCoV-D’

On 15 July 2020, Zydus announced the initiation of the adaptive Phase 1/2 clinical trials of ZyCoV-D, a plasmid DNA vaccine. In the pre-clinical toxicity studies, ZyCoV-D was found to be safe, immunogenic, and well-tolerated.

Queensland University initiated the Phase 1 trial of its COVID-19 vaccine in Australia

On 13 July 2020, the Phase 1 clinical trial of the University of Queensland for its COVID-19 vaccine began in Australia with healthy volunteers being administered the first dose.

The University projects preliminary findings in three months, and if all works as planned, the University will move to the next stage of its vaccine development immediately.

Vaccine Developers and their Candidate’s Development Stage

Healthcare companies are using various platforms, from innovative ones (like DNA-based vaccines) to the tested ways for inducing immunity in vaccinated person (e.g. live attenuated virus vaccines), to build vaccines to safeguard people against COVID-19.

Each platform offers unique benefits along with challenges, and it’s crucial to assess different platforms to ensure we get the best possible solution for the patients.

Let us delve deep and discuss:

DNA-based vaccine candidates: DNA-based vaccines work by introducing a genetically engineered blueprint of the viral gene into small DNA molecules for injection into vaccinated individuals. The cells take in the DNA plasmids and follow the instructions for developing viral proteins, which the immune system identifies as foreign, causing the immune response that safeguards against the infection.

Inactivated Virus: This type of vaccine comprises of disease-causing virus that has been killed (inactivated) (by using heat or chemicals), so it will not cause any infection.

Non-Replicating Viral Vector:

RNA-Based Vaccine: Like DNA vaccines, RNA-based vaccines provide immunity through the introduction of genetic material (RNA).

Virus-Like Particle (VLP vaccine): VLP vaccines closely resemble viruses but are non-infectious because they contain no viral genetic material.

Protein Subunit: Rather than introducing whole viruses to an immune system, a fragment of the virus is used to trigger an immune response and stimulate immunity.