Johnson & Johnson’s single-shot Covid-19 vaccine to have its trial commenced in India
World’s only manufacturer with the single-dose vaccine against Covid-19, US-based pharma giant Johnson & Johnson, has communicated to Indian regulators that it would soon be commencing its ‘bridging’ trials in India. The move can boost vaccine availability in India.
India is facing a massive surge of Covid-19 cases amid the second wave of coronavirus infections. As multiple states are reporting a shortage of vaccines, the country can really benefit from this move.
“Johnson & Johnson has sent a letter to the CDSCO (Central Drugs Standard Control Organization) that they will very shortly apply for permission to conduct clinical bridging trials in India,” the government sources said.
‘Bridging’ trial can be understood as a clinical trial where the country’s regulator permits the company to enroll a small group of participants (approximately 1000) in order to establish the immunogenicity and safety of the vaccine. It is to be noted that efficacy is not established during the bridging trial as it has already been established during the clinical trial. The trial by Johnson & Johnson in India would be similar to the one going on currently of Sputnik V by Dr Reddy’s.
Biological E has tied up with J&J to carry out its manufacturing in India.
The US regulators have already issued the EUA (Emergency Use Authorization) to Johnson & Johnson’s single dose vaccine for Covid-19 in February. The authorization was given based on Phase 3 study that showed 85% efficacy in preventing severe disease across all study regions. Also, the vaccine is 66-72% efficient in preventing severe to moderate Covid-19 cases. The vaccine also shows protection against hospitalization and death related to Covid-19, starting 28 days after administering the vaccine.
At present, India is witnessing over 1 lakh cases, with maximum new Covid-19 cases being reported by Maharashtra. States of Maharashtra, Gujarat and Rajasthan are each administering maximum doses of vaccine amid the surge.