Social media was set ablaze on July 12th with the hashtag #CoronavirusVaccine reaching number one on Twitter’s trending topics. The hysteria comes as a result of the Russian institute conducting COVID-19 clinical trials, announcing that they have completed phase-I of the clinical trials.

In true social media sensationalism, the majority of Twitter users only read the headline and assumed that the vaccine was complete. But the truth is that more tests are needed before the vaccine can reach the masses. Even at completion, the vaccine will most likely be administered to those who are at high risk first. So here are the crucial facts that you need to note about the global Coronavirus vaccine trials.

What do are the vaccine testing phases, and what do they mean? 

Traditionally, vaccine development and testing have various stages, and it’s essential to understand these so we can better anticipate the possible availability date of said Coronavirus vaccine.

The first steps are done in the laboratory and typically on animals: 

Exploratory Stage: basic lab research

Pre-Clinical Stage: this is usually conducted on animals to assess the safety of the candidate vaccine

Apply to the clinical trial regulatory board: provide details on the implementation of the said study, and once the board has approved, the study goes forward to the three phases of testing.

The next step is clinical studies with human subjects:

Phase I Vaccine Trials: the safety and tolerability of the vaccine is tested on a small group of volunteers

Phase II Vaccine Trials: a larger group of individuals participate to test vaccine’s safety, immunogenicity, proposed doses, schedule of immunisations, and method of delivery

Phase III Vaccine Trials: bigger trials are conducted to test the vaccine against a placebo; the goal is to assess safety, side effects and efficacy.

The next steps are approval and licensing. After a successful Phase III, the vaccine developer needs to submit to the regulatory board; and the board will monitor production, inspect facilities, and review potency and safety of the vaccine. After approval, vaccines continue to be closely monitored through Phase IV Trials.

Phase IV Trials: continue to test the vaccine for safety and efficacy. 

The Russian COVID-19 vaccine is currently at Phase II trial stage. Even with the success of these trials, the World Health Organization states that it will be at least 12 to 18 months before a Coronavirus vaccine will hit the market.

 South Africa also announced Coronavirus vaccine clinical trials on June 23rd. The reason for conducting our trials as explained by Professor Shabir Madhi, who leads the clinical trials is because:

“The legacy of vaccines shows that they don’t necessarily work similarly across different populations. So if we want to be one of the early adopters, in terms of implementing vaccination against COVID-19 as part of our immunisation programme, we really need to generate data applicable to the local context.”

When will we have a COVID-19 vaccine?

If trials go well; Sciencefocus.com states that as early as the first half of 2021. There is no certainty that the trials will be successful so, no-one can definitively say. All we can do now as a nation is adhere to the lockdown rules and COVID-19 safety regulations


Sources:

https://indianexpress.com/article/explained/why-russian-coronavirus-covid-19-vaccine-is-far-from-ready-6503583/

https://www.iol.co.za/news/world/russian-institute-claims-success-in-human-trial-of-covid-19-vaccine-50933122

https://www.iol.co.za/sunday-tribune/news/sas-first-covid-19-vaccine-trial-brings-hope-50874726

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

https://clinregs.niaid.nih.gov/country/south-africa#regulatory_authority

https://www.samrc.ac.za/news/first-covid-19-vaccine-trial-south-africa-begins

https://www.iol.co.za/news/south-africa/gauteng/covid-19-vaccine-trial-in-south-africa-everything-you-need-to-know-50676093

https://www.sciencefocus.com/news/covid-19-vaccine-ready-in-first-half-of-2021-if-trials-go-really-well/

https://www.nationalgeographic.com/science/2020/06/how-we-will-know-when-coronavirus-vaccine-is-ready-cvd/

https://www.gov.za/coronavirus/guidelines