The Pune-based Serum Institute of India (SII), a global frontrunner seeking to develop a safe and effective COVID vaccine, has registered its second and third phase trials of the Oxford-AstraZeneca Coronavirus (Covid-19) vaccine candidate – ‘Covishield’- with the Clinical Trials Registry of India (CTRI). The trails will be conducted on 1,600 healthy participants across India.
New Delhi’s prestigious All India Institute of Medical Sciences (AIIMS) is one of the seventeen sites selected to conduct Phase II and III, observer-blind, randomized, controlled study, to check the safety and immune response of the vaccine in healthy Indian adults. Planned as a 7-month study, the first enrolment is scheduled for the 24th of August, 2020, as per the CTRI.
The world’s largest vaccine manufacturer by the number of doses produced and sold globally, the SII shares a manufacturing partnership with AstraZeneca to produce the Oxford-AstraZeneca vaccine. Dr. Prasad Kulkarni the principal investigator for SII, will spearhead the trials at the seventeen hospitals pan-India, including Andhra Medical College (Visakhapatnam); JSS Academy of Higher Education and Research (Mysore); Seth G. S. Medical College and KEM Hospital (Mumbai); KEM Hospital Research Centre (Vadu), B J Medical College and Sassoon General Hospital (Pune). While the KEM Hospital Research Centre’s Ethics Committee has received the mandatory approval for the trials, the approval for the rest of the 16 hospitals is under process.
Covishield will be administered as a two-dose schedule on days 1 and 29 as 0.5 ml dose intramuscularly. Placebo will be administered as a two-dose schedule on days 1 and 29 as 0.5 ml dose intramuscularly. Healthy participants, both men and women, selected for the trials are above the age of 18. Those, who are ineligible, include people with acute illnesses with or without fever at the time of study vaccine administration, history of laboratory-confirmed Covid-19 disease in household contact or close workplace contact, etc.
Earlier on 7th August, 2020, SII announced that it would receive $150 million in funding from the Bill and Melinda Gates Foundation and the GAVI vaccines alliance to make 100 million COVID-19 vaccine doses for India and other emerging economies as early as 2021.
Global Updates on the Development of Coronavirus Vaccine:
The Oxford-AstraZeneca vaccine candidate could well be the first to be available to India, provided it gets the required clearances by the year-end. SII has already received a nod from for India’s top drug regulatory body for conducting phase-II and III clinical trials on the Oxford Covid-19 vaccine.
The World Health Organization (WHO) has called for a global pact aimed at providing easy and equitable access to Covid-19 vaccine. The COVAX global vaccines facility will drive funds from wealthier countries and non-profits to develop the vaccine and distribute it equitably around the world. The programme is aimed at delivering 2 billion doses of effective, approved Covid-19 vaccines by the end of 2021.
American biotechnology organisation, Moderna, the first US company to conduct the third phase of clinical trials of the potential vaccine, aims to enrol 30,000 volunteers for its trials (as per a CNN report).
As per PM Scott Morrison, Australia has secured access to a “promising” vaccine. Australia recently sealed a deal with Swedish-British pharmaceutical company, AstraZeneca to receive the vaccine it is developing with Oxford University. Morrison said that country would manufacture it and offer free doses to the entire population.
The state-owned Chinese pharmaceutical company, SinoPharm also said its vaccine will be commercially available by the end-2020. As per a Chinese daily, Chairman Liu Jingzhen assured that the vaccine would cost less than 1,000 yuan ($140) and would be administered in two shots with a 28-day gap.