COVAXIN: Covid-19 Vaccine What No One Is Talking About

COVAXIN: Covid-19 Vaccine What No One Is Talking About

Recently, in June 2020, India based biotechnology company Bharat Biotech has secured regulatory approval from the Drug Controller General of India (DCGI) to carry out its human clinical trials for the advancement study of its Covid-19 vaccine, COVAXIN.

COVAXIN: Covid-19 Vaccine What No One Is Talking About

Origin of Vaccine

If we look back sometimes earlier, around 15^th century, both Chinese and Turks used dried crusts of small pox lesions either by inhalation and insertion into cut methods to induce immunity against small pox. That was the crude initial attempt towards immunization. Afterwards till the end of 18^th century, the method that was followed during this time span is known as inoculation means ‘to graft’. The inoculator usually used a lancet wet with fresh matter collected from a ripe pustule of some person who suffered from smallpox and it was then subcutaneously introduced into the nonimmune person’s body. However, this inoculation procedure led to the spreading of other blood borne diseases including clotting of blood and reached to the level of threat towards another epidemic. The procedure, thereafter named as variolation. Followed by Edward Jenner’s experiments (1796) with cowpox led to improved smallpox immunity towards the step of immunization and development of vaccination (1). Hence, vaccination can be considered as descendant of inoculation or variolation towards immunization. The  vaccine for smallpox contains vaccinia virus (Variolei Vaccinae) from cow and hence the naming.

COVAXIN: Covid-19 Vaccine What No One Is Talking About

Vaccine Development Clinical Trials

Here are the stages followed methodically from the exploration to the advancement of a new vaccine for clinical approval (2).

Stage 1 trial is a preclinical trial that includes exploration, animal testing and submission of the application for the investigational new drug (IND) to FDA (Food and Drug Administration). It takes approximately 2-4 years for this first stage of clinical trial.

Stage 2 trial comprises testing of the investigational drug on humans and it relies on three phases. Phase 1 is a kind of trial on a very small group of people who knows whether or not the vaccine has been administered on them. On success of phase 1, phase 2 comprises trials on randomly chosen groups with control groups. Phase 3 is trial targeting completely towards safety of mankind monitoring for the occurrence of side effects in long term (if any). Therefore, it can take even more than 2 years. On success, FDA allows license for the production of the IND but keeps an eye on its production and efficacy in many ways. The drug company producing the drug may call for a phase 4 trial also to check its effectiveness on general people.

COVAXIN: Covid-19 Vaccine What No One Is Talking About

COVAXIN development

COVAXIN has been developed by Bharat Biotech India in collaboration with National Institute of Virology (NIV) of ICMR (Indian Council of Medical Research). NIV scientists are already working on three different vaccines against SARS-CoV-2. One of the vaccines has been named as COVAXIN which is an inactivated vaccine with killed pathogens (viruses in this case). Hence, these availabilities have already saved time for exploration of a new vaccine against Covid-19. Recently, Bharat Biotech MD has already confirmed about animal testing (on rat, mice, rabit) of COVAXIN and thus enforced about animal safety as well (3). Hence, it is on the verge of initializing Stage 2 trial.

COVAXIN: Covid-19 Vaccine

COVAXIN: Covid-19 Vaccine What No One Is Talking About

COVAXIN advancement

Earlier ICMR had to launch COVAXIN by August 15 as indicated by DG-ICMR (4). However, what it seemed that the groups behind COVAXIN would not be going to follow the stage 2 trial in methodical way, rather they would follow randomised controlled clinical trials (5). That meant the human trials would be conducted in randomly chosen groups and controls with the incorporation of different institutes (6). The efficacy and safety of COVAXIN are still a matter of question that are needed to be addressed within this short period of time. Hence, the launching of COVAXIN is yet to be decided would be delayed as per the latest news (7).

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Dr. Supriya