Bharat Biotech’s Covaxin gets nod for Thrid phase clinical trial.

India’s indigenous COVID-19 vaccine candidate, COVAXIN, has received the nod for Phase-3 clinical trials in the country on October 23, 2020. The vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) .

Key Facts

  • The vaccine was given approval by the Subject Expert Committee which functions under the drug regulator Drug Controller General of India (DCGI).
  • In the Third Phase of trials, the potential vaccine candidate will be tested on over 28 thousand people aged 18 years and above.
  • The tests will be conducted across 10 states and 19 sites including Delhi, Mumbai, Patna and Lucknow.

Background

The vaccine has been generating robust immune responses in primates who have been exposed to COVID-19 infections. The vaccine was tested in 12 hospitals on volunteers between ages 18 and 55 years in phase one and two of the trials. The trials were conducted in states including Delhi, Hyderabad, Kancheepuram, Rohtak, Goa, Patna and Bhubaneshwar.

About COVAXIN

The COVAXIN vaccine was derived from a strain of the virus which was isolated by the National Institute of virology in Pune. In the process, firstly, an inactivated vaccine is developed that comprise of dead virus. After that, the vaccine is injected into the human body. He vaccine does not harm the body rather induces the immune system. The immune system then create antibodies against the virus. In this way, human body becomes immune to the infection without being infected. It was recently decided that COVAXIN will use Alhydroxiquim-II in order to boost immune response. This was decided to enhance the action of inducing antibody responses to vaccine antigens.

Other Vaccines in India

Three vaccines are currently under trial in India namely- COVAXIN, ZyCoV-D vacines by Zydus Cadila and the Oxford University Vaccine. The ZyCoV-D vaccine is also in Phase -2 of human clinical trials.