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Is the COVID-19 or coronavirus vaccine the only way for life to return to normal?
This is a question present in the back of our collective minds.
A microscopic virus has changed the world as we knew it in just a few months, and has brought the most developed societies and communities to its knees.
All eyes now look to the scientists working to find a solution to prevent further carnage. And as the number of cases climbs each day, various pharma giants are working together to develop a coronavirus vaccine.
Are we close to developing a vaccine? How long does the process take, anyway?
Here’s what you need to know.
The Stages Of Vaccine Development
Vaccine development involves various steps before the concerned authorities can finally license it. These include:
- Pre-clinical development
- Clinical development
- Approval and licensing
Pre-clinical development is the laboratory phase in which the potential vaccine concept is created and evaluated in terms of efficacy in animals.
Clinical development is usually performed in three phases:
- Phase I: It involves small-scale trials where researchers assess the immune system response to the potential vaccine for its safety in humans.
- Phase II: The trial is performed on a larger batch to evaluate the safety, side-effects and immune response to the potential vaccine candidate.
- Phase III: If the potential vaccine progresses to this stage, it is studied in natural disease conditions. Here, thousands of volunteers are tested over a period to judge the vaccine’s safety and efficacy.
After the potential vaccine has crossed all three phases successfully, it is sent to the regulatory authority for licensing and approval and marketed for human use.
Let’s learn about the companies that are making great progress in developing a coronavirus vaccine and the probable timeline for each.
The Coronavirus Vaccine: Current Options and Timeline
1) Moderna Vaccine; mRNA-1273
Moderna Inc, a US-based pharmaceutical is touted as one of the top contenders of the coronavirus vaccine. The preclinical trials of their potential vaccine, mRNA-1273 has shown promising results. The mRNA technology involves injecting fragments of the viral genetic material into the body.
The phase-I trial was conducted on 45 healthy volunteers. Eight of these produced more antibodies than COVID-19 patients, soliciting a better immune system response. The results showed the potential vaccine to be generally safe.
The company has already received fast-track approval for phase II trials by the FDA. It is expected to be performed on around 600 volunteers in two age groups—group 1 comprising 18-55 year-olds and group 2, above 55 year-olds.
Potential Timeline
The phase II clinical trials are expected to start in the coming week and the phase III trials, if they happen, will occur in July. Moderna has not yet mentioned when the vaccine will be available for consumers. However, they look forward to the licensing and approval in 2021.
2) Novavax Vaccine; NVX-CoV2373
Novavax Inc. has developed a vaccine candidate, NVX-CoV2373 from the genetic sequence of SARS-CoV-2, i.e. the virus that causes COVID-19.
Using Novavax’s patented Matrix-M technology, the vaccine can enhance immune response and stimulate high levels of neutralising antibodies.
The pre-clinical trials have shown dependable results, and the organisation is all set to conduct phase I trials soon. It will be administered on 130 individuals. Novavax vaccine development efforts have received funding of $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).
Potential Timeline
The phase I clinical trial will kick-start by May end, and the preliminary findings are expected in July 2020.
3) CanSino Biologics; Ad5-nCoV
CanSino Biologics is a Chinese corporation which is working with the People’s Liberation Army on its vaccine candidate, Ad5-nCoV. It is an adenovirus vector-based vaccine against COVID-19. The company has penned a deal with the National Research Council of Canada to advance bio-processing and clinical development for its potential vaccine.
It is presently in the clinical trial stage and was one of the first to enter phase II. It is important to note that the company has previously developed an approved vaccine for Ebola.
Potential Timeline
The phase II trials are expected to last for around 6 months. The findings regarding the safety and efficacy of Ad5-nCoV vaccine will be out by early 2021.
4) INOVIO Pharmaceuticals; INO-4800
The vaccine candidate of Inovio pharmaceuticals, INO-4800 was designed using INOVIO’s proprietary DNA medicine platform after the publication of the genetic sequence of COVID-19. The pre-clinical trials have shown some great developments with phase I trials already underway.
It is important to note that INOVIO is the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS). Till now, it has received total funding of $17.9 million from the CEPI.
Potential Timeline
The phase I trial has 40 human volunteers enrolled already, and phase II is expected to go on floors in the last week of May. The results of the safety and efficacy of the vaccine candidate will be shared by late June.
5) Pfizer and BNTECH Vaccine; BNT 162
The US-based drug-maker Pfizer has collaborated with the German company, BNTECH for their potential coronavirus vaccine, BNT 162. They have devised four vaccine candidates based on messenger RNA format. Out of these, three contain nucleoside modified mRNA and the other, self-amplifying mRNA.
They’re currently in phase I / II clinical trial. For the phase I / II trial of its four potential vaccine candidates, 360 healthy individuals will be given different dosing regimes in separate groups.
Potential Timeline
They began clinical trials in Germany and parts of the US in March. If successful, the company hopes to produce a million vaccines by October, this year.
6) Sinovac Biotech; PiCoVacc
It is a Beijing-based Chinese biopharma company. It is presently in a combined phase I/II trial stage with the first set of dosing already completed. Its vaccine candidate, PiCoVacc aims to generate an immune response by exposing the body to inactivated cells of the novel coronavirus.
The pre-clinical trials were successfully performed on monkeys in which those who were given high doses were largely found to be protected against this deadly infection.
Potential Timeline
The clinical trials started in China in April and are expected to take a couple of months before results. The company, however, has not discussed when it hopes to have the vaccine completed.
How About COVID-19 Vaccine Progress in India?
The Indian government has allocated Rs. 100 crore from the PM-CARES fund to support the research and development of a potential coronavirus vaccine. As of May 2020, the Indian Council of Medical Research (ICMR) has partnered with Bharat Biotech International Limited to develop a vaccine candidate using an isolated virus strain at the National Institute of Virology, Pune.
The ICMR is currently conducting a 10-month trial on the BCG (Bacillus Calmette-Guerin) vaccine which is commonly used against tuberculosis. The study will focus on the vaccine’s potential in reducing the COVID-19 fatality rate among people aged above 60. It is expected to cover 1450 elderly volunteers in six red and orange zones.
India, being one of the world’s largest vaccine manufacturers in volume, has over 30 potential vaccine candidates at initial stages of development as per Professor K. VijayRaghavan, Principal Scientific Adviser to the union government.
What The Future Holds: Possible Case Scenarios
Vaccine development involves a planned process of extensive research and trials that usually take time before finally becoming available for public use.
Even if it is made on a fast-track basis, it will essentially take more than a year before you can use it. The mass production process is another challenge that companies will face. A tried and tested coronavirus vaccine that is readily available for everyone is still a distant possibility.
Moreover, one cannot rule out the odds of never finding a vaccine or a possible cure to COVID-19. In such a case, you need to be prepared and take all necessary precautions to save yourself from this highly contagious virus. We’ll need widespread changes in our social behavior and everyday hygiene to learn how to live with a prevalent and potentially deadly virus.
As companies work on their potential cures and the government scrambles to stabilize the economy, people need to stay away from myths and false facts, and follow regular coronavirus vaccine updates from reliable sources like the WHO and the central government.
In the absence of a vaccine, being aware, staying alert and putting hygiene first are the only things that can currently help in surviving this pandemic.
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