- Governments are joining hands with healthcare players who are in the late stages of clinical trials and have demonstrated positive data in the clinical development of their investigational vaccine candidates.
- Currently, four investigational COVID-19 vaccine candidates are under the late stages of the clinical trial.
- Pfizer and BioNTech also remain on track to initiate projected Phase 2b/3 clinical studies later this month.
COVID-19 pandemic has infected more than 15.29 million people across the globe since the outbreak, with over 628k reported deaths (as on 24 July 2020 according to the WHO). There is no vaccine available yet to protect against the deadly novel coronavirus with researchers and scientists worldwide working continuously to find a cure.
In the first part of this 3-part series, we discussed 50 vaccine candidates who are under clinical and preclinical development, and in the second part, we highlighted 55 candidates in preclinical studies.
In continuation of the series, in this third part, we will discuss the remaining vaccine candidates who are under preclinical studies with different technologies.
In this unimagined and unpredictable scenario, healthcare companies are investing significant time and money (either through external funding or collaborating with the governments) to ramp up their manufacturing facilities even before the authorization of their respective vaccine candidates from regulatory bodies. Moreover, governments are also providing funds to healthcare companies with initial promising data to accelerate the process of vaccine development.
Governments are joining hands with healthcare players who are in the late stages of clinical trials and have demonstrated positive data in the clinical development of their investigational vaccine candidates. On 22 July 2020, Pfizer and BioNTech revealed that Trump Administration secured 100 million doses of their vaccine BNT162 for US$1.95 billion.
At present, four vaccine candidates are under the late stages of the clinical trial-
- Chinese company Sinovac Biotech is conducting Phase 3 clinical trials of COVID-19 vaccine in Brazil.
- China’s Sinopharm launches Phase 3 trial of its COVID-19 vaccine in UAE.
- AstraZeneca’s experimental COVID-19 vaccine is also in late-stage Phase 3 clinical trials.
- Moderna developed an investigational vaccine, mRNA-1273 which is one of the major candidates in the list and is likely to enter Phase 3 clinical trials later in July.
In addition to these four, Pfizer and BioNTech also remain on track to initiate projected Phase 2b/3 clinical studies later this month and aim for regulatory assessment as early as October 2020. Both the companies will manufacture up to 100 million doses by the year 2020 end and potentially over 1.3 billion doses by the end of 2021.
As per the latest landscape (24 July 2020) provided by the World Health Organization, there are a total of 25 vaccine candidates under clinical development, and 141 are in preclinical evaluation.
The below pie charts represent the breakup of the vaccine candidates based on their stage of development (as on 24 July 2020):
Let us shed some light on how far countries have reached in the development of COVID-19 vaccine-
United States Working Progressively to Develop COVID-19 Vaccine by year-end
Trump Administration is providing funds to the health care companies for accelerating the development of COVID-19 vaccine.
US-based healthcare player Pfizer Inc (Nasdaq:PFE) is jointly developing COVID-19 vaccine with a German-based drug maker BioNTech SE (Nasdaq:BNTX). Both the companies remain on track to start a projected Phase 2b/3 clinical trial for safety and efficacy this month. Notably, two of the four candidates in the BNT162 program (BNT162b1 and BNT162b2) received FDA’s Fast Track Designation earlier this month. Moreover, the US government has secured 100 million doses of Pfizer/BioNTech vaccine candidate for US$1.95 billion and can acquire an additional 500 million doses.
Another US-based company Moderna Inc (Nasdaq:MRNA) is on the verge of starting a Phase 3 clinical trial of its vaccine candidate mRNA-1273. During mid-May, Moderna revealed positive interim data from Phase 1 clinical study of its mRNA vaccine. In early July, the Company completed enrollment of Phase 2 clinical trial of mRNA-1273.
Notably, the Company is Finalizing protocol for Phase 3 trial, anticipated to commence in July 2020.
Chinese Companies Entered in Late Stages of Clinical trials-
Two Chinese companies, Sinovac and Sinopharm, have entered in late-stage clinical studies.
Sinovac Biotech is collaborating with the governments of several countries to conduct Phase 3 clinical trial of its vaccine and commence Phase 3 trial in Brazil. Another Chinese pharmaceutical company, Sinopharm Group, announced that its COVID-19 vaccine could be ready by year-end. The Company has initiated a Phase 3 clinical trial in the UAE.
The vaccine candidate, developed by Oxford University and AstraZeneca, is in Phase 2/3 of human trials. Recently, the group has announced promising results of its COVID-19 vaccine, AZD1222 in early human trials. The interim data from the Phase 1/2 trial demonstrated AZD1222 was well tolerated and produced robust immune responses against the SARS-CoV-2 virus.
Late-stage Phase 2/3 clinical trials of AZD1222 are currently underway in the UK, South Africa, and Brazil and are due to commence in the United States.
To Know More, Do Read: Oxford/AstraZeneca’s AZD1222 Shows Promising Results in Early Human Trials
In Australia, Queensland University Commenced Phase 1 Clinical trial
On 13 July 2020, the Phase 1 trial of COVID-19 vaccine by the University of Queensland commenced in Australia with healthy volunteers being administered the first dose. The first human trial will evaluate the safety of the vaccine and the immune response it generates in a group of healthy volunteers.
The preliminary results from this trial are anticipated after three months, and if all works as planned, the University will commence the next stage of its vaccine development.
India Commences Phase 1/2 Clinical Trials
In India, two healthcare companies have moved their candidates in clinical development.
Bharat Biotech has successfully developed India’s first COVID-19 vaccine candidate COVAXIN™ and is conducting Phase1/2 clinical trial.
Cadila Healthcare Limited (Zydus) begins human dosing of its plasmid DNA vaccine ‘ZyCoV-D’ in Phase 1/2 clinical trial. The Company will be enrolling more than 1000 subjects across multiple clinical study sites in India.
German Company Initiates Phase 1 Clinical trial
Germany-based biopharmaceutical company CureVac is set to initiate the Phase 1 clinical trial of its SARS-CoV-2 vaccine candidate in Germany and Belgium. The Company has obtained financial backing for its COVID-19 vaccine development from the CEPI (Coalition for Epidemic Preparedness Innovations).
Let us now have a look at the remaining set of vaccine candidates which are under preclinical development and anticipated to move into clinical development-
DNA-based vaccine candidates:
Inactivated virus vaccine:
Live Attenuated Virus Vaccine:
Non-Replicating Viral Vector:
Replicating Viral Vector
Virus-Like Particle (VLP vaccine):