All you need to know about India's COVID-19 vaccines
As the coronavirus outbreak continues to surge worldwide, efforts to develop a vaccine have been expedited. Even with reassuring recovery rates, the need for a vaccine is urgent given the contagiousness of SARS-CoV-2, the coronavirus that causes COVID-19. Amid a global race to develop a vaccine, India, too, is scrambling to launch its two vaccine candidates. Here's all you need to know about them.
COVAXIN has been created from an "inactivated" strain of the coronavirus by the Bharat Biotech and the Indian Council of Medical Research's National Institute of Virology (ICMR-NIV). An inactivated vaccine uses the killed version of the disease-causing pathogen to generate an immune response. Vaccines for polio and rabies are among those that utilize an inactivated strain.
The ICMR has roped in 12 institutes to conduct clinical trials for COVAXIN. The vaccine has been cleared for Phase-I and Phase-II trials by the Drug Controller General of India (DCGI). The process for trials began on Tuesday at Hyderabad's Nizam's Institute of Medical Sciences (NIMS). ICMR Director-General Dr. Balram Bhargava had asked all institutes to ensure that enrolment is initiated by July 7.
375 participants will take part in Phase-I trials. The participants will be split into three groups of 125 and administered two doses— one each of the candidate and control—14 days apart. After the Phase-I trial is completed successfully, 750 people will participate in Phase-II trials.
The ICMR has urged all institutes to fast-track the development of the vaccine and is aiming to "launch the vaccine for public health use latest by August 15 2020." Despite the accelerated timelines to develop a vaccine in the face of a worsening pandemic, researchers and experts say the ICMR's timeline is rushed and may have long-term adverse impacts.
Notably, Dr. Bhargava's letter dated July 2—that established the August 15 timeline—indicated that the preclinical testing for COVAXIN had not been completed at the time. According to the Clinical Trials Registry-India (CTRI) website, the trial was only registered on July 1. However, the ICMR defended itself saying that it was acting in accordance with the globally-accepted norms.
Separately, Zydus Cadila Healthcare has also been given the DGCI's nod to conduct Phase-I and Phase-II trials for its vaccine candidate, ZyCoV-D. The trials will be conducted on 1,000 volunteers across multiple sites, Mint reported. Zydus Cadila group Chairperson Pankaj Patel said the trials could take up to three months to finish. The trials were registered on July 4, as per the CTRI website.