Johnson and Johnson's single-dose adenoviral COVID-19 vaccine has received emergency use authorisation by the Central Drugs Standard Control Organisation (CDSCO) in India on Saturday making it the fifth vaccine to receive approval in the country.
Along with Serum Institute of India's Covishield, Bharat Biotech's Covaxin, Dr. Reddy's Laboratories distributing the Russian vaccine Sputnik V, and Cipla receiving approval for importing the Moderna vaccine, Johnson and Johnson's Janssen Ad26.COV2.S COVID-19 vaccine will be the latest vaccine available to Indians. India has so far administered over 50 crore vaccine doses among its citizens.
The vaccine is one of the three vaccines produced by US manufacturers. Unlike Moderna and Pfizer that use mRNA technology, the Jannsen vaccine follows the technology of using an adenovirus as a vector to carry the spike protein of SARS-CoV-2. The Oxford-AstraZeneca/ Covishield vaccine and Sputnik V vaccine are also made using similar technology.
On Monday, August 2, the pharmaceutical was in the news for withdrawing its proposal for a bridging trial in India. The company had then stated that it was taking this step as the Indian government had removed the mandate for internationally approved vaccines (US FDA, EMA) to conduct bridging trials in the country. The manufacturer applied for EUA on August 5.
This single-dose vaccine was found to be 85 per cent effective against SARS-CoV-2 according to results of the Ensemble trial in the US. Results of a clinical trial conducted in South Africa show that the vaccine is effective against the Delta variant that is now rampant across the world. Only 0.5ml of the vaccine has to be administered through an intra-muscular injection.
The recent clinical trial also suggests that the Jannsen vaccine may not require a booster shot as was being discussed earlier.
Although approved and now widely in use in several countries, the Johnson and Johnson vaccine has had its fair share of controversies. In March 2021, there were reports of links between the vaccine and blood clots later followed by the US FDA asking a plant in Baltimore to stop production in April 2021. US FDA found that batches of the vaccine were contaminated with products used in the AstraZeneca vaccine that were also being manufactured at the same plant.
There were also reports of men reporting symptoms of Guillain-Barre syndrome after receiving the JnJ vaccine. The US CDC asked the producer to add a warning about the possibility of developing this paralysis even though there was no causal link between the vaccine and the disease.
Updated On: 2021-08-09T10:25:51+05:30