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Shot Roster: COVID-19 Vaccines In Human Trials

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The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University.

A safe and effective vaccine against SARS-CoV-2 is necessary to stop the novel coronavirus from spreading. A number of drug companies and research organizations are working on a vaccine for COVID-19.

According to the World Health Organization's database, there are seven COVID-19 candidate vaccines in human testing and over 90 in preclinical evaluation.

In this article, we present to you the COVID-19 vaccines that are currently in human trials - their stage of development, developers, expected time frame, etc.

1. BioNTech's BNT162

BioNTech SE's (BNTX) BNT162 vaccine program to prevent COVID-19 infection includes four vaccine candidates, each representing different mRNA formats and target antigens.

The four vaccine candidates under the BNT162 vaccine program are in phase I/II trial in Germany. The dose-escalation portion of the phase I/II trial will include approximately 200 healthy subjects between the ages of 18 to 55. The second part of the study will enroll subjects with a higher risk for a severe COVID-19 infection.

BNT162 is being jointly developed by BioNTech and Pfizer (PFE).

During its earnings conference call on Apr.28, Pfizer said that initial data from the BNT162 vaccine trial is "expected in May-June, with a potential for emergency use or accelerated approval probably in October and onwards".

Pfizer and BioNTech plan to initiate trials for BNT162 in the United States upon regulatory approval, which is expected shortly.

BioNTech is collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct trials.

2. University of Oxford's ChAdOx1 nCoV-19

ChAdOx1 nCoV-19, developed by the University of Oxford researchers, is under a phase I/II study in the UK in healthy adult volunteers aged 18-55 years.

ChAdOx1 nCoV-19 vaccine is based on a nonreplicating engineered chimpanzee adenovirus vector, ChAdOx1.

The trial is designed to enroll up to 1,102 participants, recruited across multiple study sites in Oxford, Southampton, London, and Bristol. Results from the trial are expected to be available by May 2021.

Serum Institute of India is collaborating with Oxford University for the manufacture of the ChAdOx1 nCoV-19 vaccine.

3. CanSino's Ad5-nCoV

CanSino Biologics Inc.'s recombinant novel coronavirus vaccine Ad5-nCoV is under phase II trial in healthy adults over 18 years of age in China.

Ad5-nCoV, co-developed with Beijing Institute of Biotechnology and the Academy of Military Medical Sciences, is built upon CanSino's adenovirus-based viral vector vaccine technology platform.

The phase II trial is designed to enroll 500 participants. Results from the trial are expected to be available by January 2021.

4. Inovio's INO-4800

INO-4800, being developed by Inovio Pharmaceuticals Inc. (INO) is a DNA vaccine candidate to protect against the novel coronavirus SARS-CoV-2.

INO-4800 is under a phase I clinical trial in the U.S., and is fully enrolled with all 40 healthy volunteers. The interim immune responses and safety results from the trial are expected in late June.

If all goes well as planned, INO-4800 will advance into phase II/III efficacy trial, which is planned to be potentially initiated this summer.

INOVIO has partnered with Beijing Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively.

The Company has also secured funding from CEPI, the Bill & Melinda Gates Foundation, and the U.S. Department of Defense for the development of INO-4800.

5. Wuhan Institute of Biological Products' COVID-19 vaccine

The COVID-19 vaccine being developed by Wuhan Institute of Biological Products Co. Ltd., a subsidiary of China National Pharmaceutical Group Co., Ltd. (Sinopharm), is an inactivated vaccine, which means it is made from inactivated forms of the virus SARS-CoV-2.

According to reports, the inactivated COVID-19 vaccine has entered the phase II portion of a phase I/II trial in participants aged 18 to 60.

In the phase I part of the trial, 96 persons have been administered the vaccine. "The vaccine has shown good safety so far and participants are still under observation", reports Xinhua, the national news agency of China.

6. Sinovac's PiCoVacc

PiCoVacc, being developed by Sinovac Biotech Ltd., is a purified inactivated SARS-CoV-2 virus vaccine candidate.

This vaccine is under phase I portion of a phase I/II trial in China. The trial is designed to enroll a total of 744 participants - 144 at phase I and 600 at phase II.

The results from the trial are expected to be available by August 2020.

7. Moderna's mRNA-1273

Moderna Inc.'s (MRNA) mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine, under phase I testing in healthy adults in the U.S.

The trial has completed enrollment of 45 healthy adult volunteers of ages 18 to 55 years and is assessing the safety, reactogenicity, and immunogenicity of mRNA-1273.

The phase I trial is led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Full results from the study are expected by June 2021.

Meanwhile, the Company has sought FDA clearance to initiate a phase II study of mRNA-1273 if supported by safety data from the phase I study.

If all goes well, the Company plans to initiate a phase II trial of mRNA-1273 this quarter (Q2, 2020), and will enroll 600 healthy participants across two cohorts of adults ages 18-55 years and older adults ages 55 years and above.

Subject to data from the phase I and phase II studies and discussions with regulators, the Company intends to begin a phase III study of its mRNA-1273 vaccine in the fall of 2020.

Coalition for Epidemic Preparedness Innovations (CEPI) and the Biomedical Advanced Research and Development Authority (BARDA) are also funding the development of Moderna's mRNA vaccine.

*Johnson & Johnson's COVID-19 vaccine candidate Ad26 SARS-CoV-2 is expected to enter human clinical trial by September 2020.

When will a vaccine for COVID-19 be available?

Vaccine development is a complex process and it usually takes 10 to 15 years under a traditional vaccine development model. However, there are exceptions. Say, for example, it took 4 fours to develop and get approval for a mumps vaccine that was first licensed in 1948, and in the case of the Ebola vaccine, which was approved in December 2019, it took 5 years.

But given the urgent need to address the ongoing pandemic, a COVID-19 vaccine requires a much-shortened timeline, without compromising long-term safety and efficacy.

With scientists, physicians, funders, and manufacturers coming together as part of an international collaboration, coordinated by the World Health Organization, many experts are optimistic that a COVID-19 vaccine could be available by the summer of 2021.

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