The first Indian indigenous vaccine is underway for public health use. ICMR targets the COVID-19 vaccine to be ready by August 15.
COVID-19 Vaccine to be Ready by August 15
Balram Bhargava, director-general of the ICMR wrote to research groups about the launch of the COVID-19 vaccine by 15th August. The drug is manufactured by Hyderabad-based drugmaker Bharat Biotech (BB). He sent a letter to several institutions around the country, asking them to begin the clinical trials for a COVID-19 vaccine named COVAXIN. Further, he added that the project is the topmost priority of the government.
The apex medical institute has identified twelve clinical trial sites and has asked principal investigators to initiate the subject of enrolment by 7th July. Bharat Biotech stated that the researchers would fully adhere to the quality standards and safety guidelines while developing the vaccine. Ahmedabad-based Zydus Cadila has also received approval for conducting Phase I and II human clinical trials.
Experts Doubt the Time Frame Announced
Health experts have expressed their concern for the time given to develop the vaccine. They say that Phase 1 of vaccine development, which focuses on checking the toxicity of a vaccine on a small population, takes around a month. After that, the second phase, looking at efficacy and determining the dosage, takes six months. After that, the researchers carry out Phase 3, which takes into account the safety of the vaccine on a large population. Phase 3 requires another six to nine months. Moreover, of the 12 institutions marked for clinical trials, only five ethical committees approved of the trials. However, the government approves the launch of the COVID-19 vaccine after two trials subject to its promising results and submission of additional data.
Currently, Oxford University-AstraZeneca’s and Moderna’s COVID-19 vaccine are the frontrunners and in advanced stages of development. Even then, they have a longer time frame to conclude all three phases.
In all, the decision to conduct human trails and manufacture vaccine within five weeks has raised questions. The deadline for making the vaccine available to public health use seems arbitrary, if not unethical.