COVID-19 Vaccine Development: Where Do We Stand?

Summary

• According to the WHO, there are 17 COVID-19 vaccine candidates under clinical investigation across the world.
• AstraZeneca/Oxford University began Phase 3 studies for its vaccine candidate in Brazil while Moderna is set to begin its Phase 3 trial this month.
• Korean clinical-stage company Genexine started testing the safety of a DNA-based vaccine in June; Phase 1 clinical trial is expected to complete within three months.
• US-based Inovio announced favourable interim data from its Phase I study; Phase 2/3 trial expected by August.
• India’s first COVID-19 Vaccine COVAXIN™, developed by Bharat Biotech, recently got approved for Phase 1 & 2 human clinical trials.

COVID-19 pandemic has affected more than 10.2 million lives including 506,864 deaths reported to the World Health Organization on 01 July 2020, (as of 8:18 AM CEST).

As per the information provided by the WHO, a total of 149 vaccines are being tested against the novel coronavirus. Out of the 149 candidates, 132 are under preclinical trial while 17 have advanced to clinical trials stage. Researchers are predicting the availability of a safe and effective vaccine by next year.

In this article, we will discuss some promising vaccine candidates under various stages of development across the globe:

AstraZeneca Plc and University of Oxford

A vaccine being developed by AstraZeneca Plc and the Oxford University, AZD1222 is based on adenovirus of a chimpanzee, called ChAdOx1. Oxford University announced on 28 June 2020 that Phase 3 trials commenced in Brazil on 20 June and are being conducted at three different sites in the country. The trial intends to enrol around 5k volunteers.

The vaccine candidate is under Phase 2/3 clinical trial in about 10k adult volunteers in the UK and supported by Operation Warp Speed (OWP). AstraZeneca is collaborating with other health care companies to provide its vaccine to every corner of the world after successful completion of all trials.

Recently, AstraZeneca signed an agreement Daiichi Sankyo for supplying Oxford/AstraZeneca’s vaccine candidate to Japan.

Moderna Inc

Moderna Inc is one of the companies at the forefront of vaccine development for COVID-19. Moderna is one of the select few companies selected by Trump administration under OWS and is planning to start Phase 3 study of its vaccine candidate, mRNA-1273 in July 2020.

Recently, Moderna signed an agreement with Catalent, under which Catalent will provide vial filling as well as packaging capacity. Also, it will offer employees required for 24x7 (around the clock) production at the site to support manufacturing of 100 million vaccine dosages intended for the US market starting Q3 2020.

BioNTech SE and Pfizer

A frontrunner in developing innovative cancer therapies along with treatments for other severe disorders, BioNTech SE is developing a COVID-19 vaccine in collaboration with Pfizer. The candidate, named BNT162, is an mRNA-based vaccine. Under this program, both companies are planning the production of millions of vaccine doses in 2020, going up to hundreds of millions in 2021.

In early May 2020, Pfizer and BioNTech dosed the first participants in a Phase 1/2 clinical trial in the US.

In June 2020, the Company received support from the European Investment Bank via a debt financing agreement worth up to EUR 100 million.

Sinovac Biotech Ltd

Chinese biopharma player Sinovac Biotech is testing an inactivated COVID-19 vaccine candidate called CoronaVac. On 13 June 2020, the Company disclosed preliminary results from its Phase 1/2 trial. The findings demonstrated favourable safety as well as immunogenicity.

As per a release dated 11 June 2020, the Company disclosed its collaboration with Instituto Butantan, a research institute in Brazil, for designing and performing a Phase 3 trial.

Novavax Inc

Late-stage biotechnology company Novavax Inc is developing a vaccine candidate, NVX-CoV2373 against COVID-19.

Towards May end, the Company commenced Phase 1/2 clinical trial of NVX-CoV2373, and preliminary immunogenicity and safety outcomes from the Phase 1 section are anticipated in July 2020. The Company stated that it would start Phase 2 section promptly after successful results from Phase 1 clinical trials.

INOVIO Pharmaceuticals Inc

US-based biotech player INOVIO Pharmaceuticals Inc is developing COVID-19 DNA vaccine, INO-4800. The Company recently announced favourable preliminary data from its Phase 1 trial with 94% of the participants, after two doses of the vaccine candidate, showing immune responses at Week 6. INO-4800 demonstrated safety and tolerability with no SAEs (severe adverse events). The clinical trial is funded by the CEPI via INOVIO and is backed by the Korea Center for Disease Control (KCDC) and Korea National Institute of Health.

The Company intends to start a Phase 2/3 efficacy trial during the summer subject to regulatory approval.

Clover Biopharmaceuticals

Clover Biopharmaceuticals is developing COVID-19 S-Trimer subunit vaccine candidate (SCB-2019) to combat the coronavirus. The candidate is currently in Phase 1 clinical trial and anticipates enrolling 150 healthy participants. The study will assess two adjuvant systems: pandemic adjuvant system from GSK, and Dynavax’s CpG 1018 adjuvant in combination with alum.

Preliminary safety and immunogenicity outcomes for the Phase 1 trial are anticipated in August 2020. In parallel, the Company is planning for a global Phase 2b/3 vaccine efficacy trial, which is projected to commence by year-end 2020.

Gamaleya Research Institute of Epidemiology and Microbiology

The Gamaleya Research Institute, a part of Ministry of Health Russia, launched a Phase 1 clinical trial of its COVID-19 vaccine named Gam-Covid-Vac Lyo in June. Gam-Covid-Vac Lyo is an adenoviral-based vaccine being assessed against SARS-CoV-2. The Phase 1 study is anticipated to complete in August 2020.

Genexine

A Korean clinical-stage biotechnology company, Genexine is developing a DNA vaccine against COVID-19, named GX-19 that has been approved for clinical Phase 1/2a by the Ministry of Food and Drug Safety.

The Company commenced testing the safety of the DNA-based vaccine in June; Phase 1 clinical trial is expected to complete within three months. Genexine will then start Phase 2 studies which will be conducted in multiple geographies.

Genexine is also developing a COVID-19 treatment and received approval from the US FDA to conduct Phase 1 trial.

CureVac AG

CureVac started vaccine development in early 2020 and evaluated several potential candidates before finalising CVnCoV. The Company had received regulatory approval on 17 June from German and Belgian Authorities to commence Phase 1 clinical trial of CVnCoV. The dose-escalation study will target a dose range of 2 µg - 8 µg in 168 healthy volunteers.

Imperial College London

Researchers of Imperial College London are developing a self-amplifying RNA vaccine to combat COVID-19, that boosts the manufacture of a viral protein for stimulation of the immune system. On 23 June 2020, Imperial College disclosed that the first healthy volunteer had received the COVID-19 vaccine candidate developed by its researchers.

Notably, Imperial has established a new social enterprise VacEquity Global Health, in collaboration with Morningside Ventures, for rapid development and distribution of the vaccine.

CanSino Biologics

CanSino Biologics is co-developing a recombinant novel coronavirus vaccine candidate, Ad5-nCoV, with Beijing Institute of Biotechnology (BIB). Currently, it is in Phase 2 clinical trial and is being evaluated in healthy participants aged above 18 years. CanSino Biologics is dedicated to launching its COVID-19 vaccine candidate as soon as possible without compromising its quality and safety.

Institute of Medical Biology and Chinese Academy of Medical Sciences

Researchers at the Institute of Medical Biology are developing an inactivated COVID-19 vaccine candidate at the Chinese Academy of Medical Sciences. The candidate has entered Phase 2 clinical studies in China, reported on 20 June 2020. In the Phase 2 trials, safety and immunogenicity will be evaluated further in humans.

Sinopharm and Its Subsidiaries

Chinese healthcare company Sinopharm is conducting Phase 1/2 clinical trial for COVID-19 vaccine. Both the Wuhan Institute of Biological Products and Beijing Institute of Biological Products are conducting the Phase 1/2 trials, that commenced in April 2020.

Anhui Zhifei Longcom Biologic Pharmacy Co Ltd

In June, Anhui Zhifei Longcom started Phase 1 clinical trials in China for COVID-19 vaccine. The potential COVID-19 vaccine is co-developed by Anhui Zhifei Longcom Biopharmaceutical and the Institute of Microbiology of the Chinese Academy of Sciences.

Academy of Military Medical Sciences and Walvax Biotech

People's Liberation Army (PLA) Academy of Military Sciences, Suzhou Abogen Biosciences and Walvax Biotechnology Co., Ltd are jointly developing Messenger RNA (mRNA) vaccine against COVID-19 named as ARCoV. The vaccine candidate is currently under Phase 1 clinical trial which commenced in June 2020.

India’s 1st COVID-19 vaccine being developed by Bharat Biotech

Indian biotech company Bharat Biotech has developed COVAXIN™, India’s first COVID-19 vaccine candidate. The Company is working in partnership with ICMR (Indian Council of Medical Research) and National Institute of Virology.

COVAXIN™ has been approved by the Drug Controller General of India (DCGI) for Phase 1 and 2 human clinical studies that are anticipated to commence in July 2020.