All You Need To Know About Johnson & Johnson’s Covid-19 Vaccine Trial In India
American pharma giant Johnson & Johnson is in talks with the Indian government to conduct an early-stage clinical trial of its single-dose Covid-19 vaccine in the country.
According to Reuters, the company said: "We are in discussions with the Government of India with the objective of starting a bridging clinical study of our Janssen Covid-19 vaccine candidate in India, subject to local regulatory approvals."
The news comes at a time when India is wrestling with time to boost its vaccine distribution program, which has received worldwide appreciation. But due to the current surge in Covid-19 cases, the vaccine demand is rising.
Recently, a spokesperson from J&J said that the company wants to bring a safe and effective Covid-19 vaccine for the people around the world if authorised for use by local health officials.
This vaccine—developed by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson—is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein found on novel coronavirus.
J&J said that the jab showed protection against the Covid-19 related hospitalization and death, beginning 28 days after the inoculation.
In February the Food and Drug Administration in the United States has issued an emergency use authorization (EUA) for the vaccine.
USFDA said that the vaccine was about 77 per cent effective in preventing severe or critical Covid-19 occurring at least 14 days after vaccination. But it becomes 85 per cent effective, in terms of preventing the disease, occurring at least 28 days after the inoculation.
According to the federal agency, the most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea.
In March, the World Health Organization (WHO) issued EUA for the vaccine, while the European Union also approved the use of the J&J vaccine for its inoculation program.
So far, the pharmaceutical company AstraZeneca's Covishield and homegrown Covaxin are being used in India's vaccine drive. But any approval to begin a clinical trial in India has not been granted to J&J.
According to early reports, the American company has partnered with Hyderabad-based company Biological E to manufacture its vaccine and India agreed to this as part of the first Quad vaccine initiative.
The managing director and chief executive of Biological E, Mahima Datla previously said that J&J was hoping to produce 500 million doses from its facility.
However, if J&J receives the green light to start its vaccine trial in India, drug regulators will check the efficacy rate and health-related safety issues before allowing Indians to get the shot.
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