The testing of the COVID-19 vaccine Covaxin developed by Bharat Biotech shows no side effects in its first trial and has entered the phase II trial. The trial is expected to be conducted on 380 volunteers.
This is to inform that the subject proposal was examined in consultation with SEC (Covid-19) experts held through virtual meeting on September 3, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised in 4 days, – said the Directorate General of Health Service
In the first phase of COVID-19 vaccine, blood samples of volunteers were collected to ascertain how effectively antibodies are developed, showing positive signs.
Dr. E Venkata Rao, Principal Investigator of the trial at Institute of Medical Sciences (IMS) and SUM Hospital, faculty of medical sciences, also mentioned that as soon as the volunteers were injected with the vaccine, a spike in the production of antigens was observed. Lab samples, too, did not record any adverse effects.
Each stage of development of a vaccine is crucial as it tests the safety and immune response ability. While Phase I is about safety and testing small dosage with a small group of healthy volunteers, Phase II tests the effectiveness. Phase III is a step ahead with a larger population representing a broader demographic.
We are expecting vaccines to be ready by the end of the year. It is because of the farsightedness of Prime Minister Narendra Modi that we could reach until here, said Dr. Harsh Vardhan, Health Minister of India
Government officials have also conducted meetings with important stakeholders to prioritize the production, marketing, and administration of vaccines in the coming months, he added.
Apart from Bharat Biotech, Zydus Cadila is another company that has begun human trials for COVID-19 vaccine, and another vaccine developed by Oxford University and Swedish-British drugmaker AstraZeneca is reportedly under Phase II trial at BJ Medical College.
As cases are increasing in India and globally, there is an urgent need for COVID-19 vaccine. Covaxin raises hopes, but it is still early to speculate its effectiveness for mass inoculation. The successful phase II will clarify the advantages and disadvantages of the vaccine.