NISHTA JOOTY,
Pharmaceutical Engineer

Clinical trials for a potential vaccine for COVID-19 have already started. This is unquestionably a step in the right direction. However, even if these trials and subsequent ones do not encounter any issues, we are still a few years away from having this vaccine available to the public. Under normal circumstances, it takes about a decade to bring a new vaccine to market.

Pharmaceutical companies around the world are racing to develop a vaccine for the novel coronavirus. Some companies are collaborating to minimise the development time of the vaccine. For example, GlaxoSmithKline and Sanofi are working together to develop an adjuvanted COVID-19 vaccine. According to the World Health Organisation, as of the end of April 2020, there were 77 vaccines in development.

This is very good news, but we should temper our expectations. Vaccine development is a long and complex process. Like other pharmaceutical products, vaccines undergo extensive testing and review for safety, efficacy and immunogenicity.

Research & Development

It starts with the exploratory stage which involves basic laboratory research where natural or synthetic antigens that might help prevent or treat a disease will be identified. After that, comes the pre-clinical stage which involves the use of tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity or ability to provoke an immune response.

Next is the clinical stage, which is a three-phase process and is conducted with human subjects. During phase I, small groups of people receive the trial vaccine to assess the safety of the candidate vaccine and to determine the type and extent of immune response that the vaccine provokes at different doses. In phase II, the clinical study is expanded to a larger group of several hundred individuals to study the candidate vaccine’s safety, immunogenicity, proposed doses, schedule of immunisations and method of delivery. In phase III, the vaccine is given to thousands of individuals to test for efficacy and safety. The results of the phase III testing will be determining for the vaccine to get approval and market authorisation.

Apart from the World Health Organization, other institutions such as the European Medicines Agency and the United States Food and Drug Administration oversee vaccine safety and regulation. These entities will evaluate safety and efficacy data from the trials before giving approval for a vaccine and making it available to the public. Vaccines undergo phase IV ongoing studies after the vaccine is approved and licensed to ensure continuing safety. These studies monitor effectiveness in real-world conditions.

Challenges

The issue is that we need to have enough validated data to prove that a vaccine is safe and effective. And that takes time. All stakeholders are working to compress the typical 10-year time frame for normal vaccine development, approval and market availability. The health authorities are speeding up administrative processes for the vaccines currently in development. Some pharmaceutical companies are using the knowledge already available from previous coronavirus research to cut down the time to develop a new vaccine. The World Health Organization (WHO) is considering combination trials of phase 2/3 which are expected to give faster results. Some companies are considering skipping one of the trial phases to get a vaccine out faster. Others have begun testing on humans disregarding the completion of pre-clinical trials (source: livescience.com). It is very risky to proceed to a clinical trial before knowing whether a vaccine triggers an immune response in animals. We should not forget that vaccines are given to healthy people to prevent disease. While a COVID-19 vaccine is very much needed, a rush to market without appropriate testing could put healthy people at risk. The safety of the people should prevail above all.

The challenge does not end with clinical trials. Albeit, a vaccine is rapidly developed and approved, the subsequent step is making it available to millions of people around the world. It will take time to manufacture the vaccine doses, to send them around the world and to make the vaccine available to everyone. A vaccine will be more effective if it is available before the vast majority of the global population gets infected. The worry is that by the time a vaccine is produced, we might have a completely new version of the virus. Another issue will be the availability of the vaccine to the world population. Will the vaccine be fairly and equitably distributed to all countries of the world? Will it be easily available to poor countries? Will they be able to afford it?

The pharmaceutical company that is first to bring a vaccine to market will surely grab the world’s attention and that means making more than a few headlines. For human life to become ‘normal’ again, the only permanent solution is a vaccine that will protect us from the virus, saving lives and helping society return to functioning as usual. While waiting for a vaccine, let us adopt a new way of life and do things differently…