After months of waiting for a vaccine against the coronavirus, it seems now we're almost there. With Pfizer and its German partner BioNTech applying to the US FDA for emergency use authorisation of their COVID-19 vaccine on November 21, there is a glimmer of hope to get back to our old normal soon. While here in India, Bharat Biotech, the developer of India's indigenous vaccine, Covaxin has said that it is planning to enrol about 2,000 participants each in metros for Phase-3 trials of its COVID-19 vaccine that began earlier this week. The announcement by the American pharmaceutical company for the application to the US FDA for emergency use comes just after Pfizer reported final trial results which showed that their vaccine has an efficacy rate of 95 per cent.
The US agency declined to predict how long it would take to study the vaccine data, although both Pfizer Inc and US Health Secretary Alex Azar have said the FDA could authorise the vaccine in the first two weeks of December.
Meanwhile, Bharat Biotech plans to enrol 1000-2000 participants each in four metro cities for its Phase 3 trials of Covaxin. The participants will be recruited from Delhi, Mumbai, Hyderabad and Kolkata.
Bharat Biotech said people below 18 years of age or those who tested COVID- positive will not be eligible for the clinical trial. The statement added that participation in the trial is voluntary and based on informed consent, participants will not be paid anything, other than travel fare.
The third phase human trial of Covaxin, the much-awaited indigenously developed COVID-19 vaccine, has begun at an institute in Odisha.
Earlier this week, the company said in a statement, "This is India's first Phase 3 efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in India."
The vaccine was administered to two recruits on Thursday at the Preventive and Therapeutic Clinical Trial Unit (PTCTU) at the Institute of Medical Sciences and SUM Hospital, the only institute in Odisha chosen by the Indian Council for Medical Research (ICMR) for the human trial of the vaccine.
The indigenous vaccine, which is being developed by Bharat Biotech and ICMR, has received the approval of the Central Drugs Standard Control Organisation (CDSCO) for initiating the third phase trial.
Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) for the Phrase 3 trials which will involve 26,000 volunteers across the country.