Ever since the novel coronavirus (COVID-19) escalated from Wuhan, China as a regional emergency to a global threat, drug makers all over the world, large and small have invested significant financial and human resources to be the first human history to find the most effective method, a cure to defeat the pandemic.
Organizations working on different pedagogies and techniques have been advancing in breakneck speed from Pre-clinical trials to 2nd/3rd stages of clinical trials in the span of few months, something which has been never witnessed in an industry which always required extensive decade long processes to analyze and approve an effective medication or cure.
There are more than 140 potential vaccines in different stages of development all around the world. Many use a futuristic approach based on genetic vaccination focused on RNA as well as DNA to trigger an immune response against the virus. Organizations at the forefront of development such as Moderna has achieved great progress on this front.
The British-Swedish firm, AstraZeneca is collaborating with the University of Oxford to develop a cure that uses a virus to carry the coronavirus genes into the cells and provides an immune response. Prominent firms like Novartis and Johson and Johnson are also on similar methodologies.
Other methodologies like Protein-based vaccination (backed by Novavax, Clover Biopharmaceuticals), Whole Virus Vaccine (backed by Sinopharm) and Use of Repurposed vaccines (Murdoch Children’s Research Institute)are too employed to add variety in the combat of COVID-19 pandemic.
We break it down for you to understand the process each organization is making towards the common goal of finding a viable cure against the novel coronavirus. Lets first take a look at how a possible solution moves from concept to production.
COVID-19; Phases of Vaccine Development
Preclinical Testing
The potential vaccine is first tested on monkeys and mice to see if they produce the desired immune response.
Phase 1: Safety Trials
The potential vaccine is administered to a small group of people to understand the correlations between dosage, safety and immune response.
Phase 2: Extended Trials
The vaccine is now given to several clusters of varied age groups to see the effect of the vaccine on different demographics.
Phase 3: Efficiency Trials
Test shots of vaccines are carried out on thousands of people to see how many become infected, compared to those who received a dummy drug (placebo). These mass trials decide if the vaccine shields against the virus.
Approvals
Once the test results come out with encouraging indications, relevant authorities in each nation will review the results and decide on the approvals for mass administration. It is highly likely that this step will be expedited amid desperate times.
COVID-19; Vaccines at different stages of development.
Let’s take a look at which vaccines are at which stage of the development cycle across the world. We have lined up all major research teams based on the most latest stage they are in.
Phase 3 – Likely to come up with a vaccine soon
AstraZeneca and the University of Oxford (Viral Vector Vaccine) | Phase 2/3 Trials
British-Swedish company AstraZeneca and the University of Oxford is basing its vaccines on the chimpanzee adenovirus called ChAdOx1. The vaccine is in Phase 2/3 trial in England and Phase 3 trials in Brazil and South Africa. Sponsored by US Project Operation Warp Speed, the project may have an emergency vaccine available for administration by October.
Sinopharm, China (Whole-Virus Vaccine) | Phase 3 Trials
Chinese company Sinopharm stated in June that it would be moving into Phase 3 trials. The United Arab Emirates (UAE) has reached an agreement with the company to start testing the effectiveness of an inactivated virus vaccine in the Gulf state.
The Murdoch Children’s Research Institute, Australia (Repurposed Vaccine) | Phase 3 Trials
The Murdoch Children’s Research Institute in Australia is leading a Phase 3 trial and has several other trails in the pipeline to see if the vaccine partially protects against the coronavirus. Through the repurposed vaccine approach, the team in Australia is using the Bacillus Calmette-Guerin vaccine as a reference which was developed in the early 1900s to protect against tuberculosis.
Phase 2 – Will take longer for the vaccine to come
Early this May Moderna shocked the market with assertive Phase 2 data on just eight people. The vaccine uses messenger RNA (mRNA for short) to produce viral proteins. Sponsored by the US through Operation Warp Speed, the American company is expected to go into Phase 3 trials in July and with hopes to have vaccine doses ready by early 2021.
The BioNTech-Pfizer-Fosun Pharma Collaboration is developing a vaccine that is based on mRNA. Pfizer CEO hopes that the association can deliver vaccines in October with a supply of hundreds of millions of doses by the end of 2020, and over a billion by the end of 2021.
China-based CanSino Biologics has based its vaccine on an adenovirus called Ad5, in association with the Institute of Biology at the country’s Academy of Military Medical Sciences. The team had published a paper in The Lancet this way which was the first instance where Phase 1 trial data from any COVID-19 vaccine emerged in a scientific journal.
Novavax, USA (Protein-Based Vaccine) | Phase 2 Trials
The US-based Novavax initiated a Phase 1/2 trial on a protein-based vaccine made up of microscopic particles carrying fragments of coronavirus proteins. The project has $384 million worth investment from the Coalition for Epidemic Preparedness Innovations.
Institute of Medical Biology at the Chinese Academy of Medical Sciences, China (Whole-Virus Vaccine) | Phase 2 Trials
Inventors of polio and hepatitis A vaccines, the team of researchers at the Institute of Medical Biology at the Chinese Academy of Medical Sciences began a Phase 2 trial of an inactivated virus vaccine in June.
Phase 1 – Vaccine not expected in immediate future
Inovio, USA (Genetic Vaccine) | Phase 1 Trials
US-based Inovio is working on a DNA-based vaccine. The team has plans to move into Phase 2/3 trials by July or August.
The Gamaleya Research Institute, Russia (Viral Vector Vaccine) | Phase 1 Trials
Russia’s Ministry of Health initiative, The Gamaleya Research Institute initiated a Phase I trial in June of a vaccine they call Gam-Covid-Vac Lyo. It is a combination of two adenoviruses, Ad5 and Ad26, both engineered with a coronavirus gene.
Clover Biopharmaceuticals and GSK (Protein-Based Vaccine) | Phase 1 Trials
The Clover Biopharmaceuticals and British drugmaker GSK collaboration has created a vaccine containing a protein from coronaviruses. The vaccine would be taken in conjunction with a so-called adjuvant (component triggering reaction) built by GSK to further stimulate the immune system.
Sinovac Biotech, China (Whole-Virus Vaccine) | Phase 1 Trials
China-based Sinovac Biotech is testing an inactivated vaccine called CoronaVac. The company announced earlier this month that its Phase 1/2 trials on 743 volunteers exhibited no severe adverse effects and produced an immune response. Phase III trials in China and Brazil are being prepared along with building a facility to manufacture up to 100 million doses annually.
Pre-clinical – Unlikely to come up with a vaccine in the next 12 months
Sanofi and Translate Bio. collaboration (Genetic Vaccine)
Beth Israel Deaconess Medical Center and Johnson & Johnson collaboration (Viral Vector Vaccine)
Novartis and Massachusetts Eye and Ear Hospital collaboration (Viral Vector Vaccine)
