Johnson & Johnson applies for Emergency Use Authorization of its COVID-19 vaccine in India

In a crucial development on Friday, Johnson & Johnson applied to the Drugs Controller General of India seeking the Emergency Use Approval of its single-dose COVID-19 vaccine in India. This comes days after it withdrew an application to conduct clinical trials after the DCGI rescinded a requirement in this regard. Notably, the Central Government has already constituted a team to engage with vaccine makers Pfizer, Moderna and Johnson & Johnson to address various issues such as indemnity which has not been granted to either the Serum Institute of India or Bharat Biotech. 

Single-shot vaccine

While the vaccine of Johnson & Johnson received the Emergency Use Authorization from the US Food and Drug Administration on February 27, it was included in the WHO's Emergency Use Listing on March 11. It has leveraged the Advac technology which was also used to develop and manufacture the company's Ebola vaccine. As per the phase 3 trials, it demonstrated an overall efficacy of 66.3% and 85% in preventing severe disease. Besides this, it showed protection against hospitalisation and death 28 days after vaccination.

Moreover, recent data indicated that the single-shot vaccine generated stronger neutralizing antibody activity against the Delta variant (B.1.617.2) than the Beta variant (B.1.351). Also, another study observed that the Johnson & Johnson COVID-19 vaccine provides immunity for at least 8 months. It is also effective against the Gamma (P.1), Alpha (B.1.1.7), Epsilon (B.1.429), Kappa (B.1.617.1) and D614G variants. This vaccine can be stored at 2°- 8° Celsius for a maximum of 4.5 months. 

However, the US has cautioned about a plausible causal relationship between this COVID-19 vaccine and a serious adverse event- blood clots with low platelets. So far, Johnson & Johnson is yet to request full approval for its vaccine from the US FDA, unlike Pfizer, BioNTech and Moderna. In India, the DCGI has accorded emergency use authorization to Covishield, Covaxin, Sputnik V, and Moderna. 

COVID-19 vaccination in India

After the rollback of the decentralized vaccine procurement policy, the Centre has started procuring 75% of the vaccine stock and distributing it to the states for free from June 21 onwards. Most importantly, this stock is now be used for all adults and not just those aged above 45. Without giving a specific deadline, the Centre has hinted that all adults might be vaccinated by December 2021. A total of 38,46,25,362 persons have been inoculated whereas 10,88,27,942 of them have received the second dose of the vaccine too.