Johnson & Johnson seeks nod to conduct trials of its COVID vaccine in kids aged 12-17

In a crucial development, US-based pharmaceutical firm Johnson & Johnson has applied to the Central Drugs Standard Control Organisation seeking permission to conduct clinical trials of its COVID-19 vaccine on children. The study participants will be chosen from adolescents aged 12-17 years. At present, Bharat Biotech and Zydus Cadila are testing their respective novel coronavirus vaccines for children.

Earlier on August 7, the Drugs Controller General of India approved the emergency use of this single-dose vaccine in adults. However, not even a single dose of the Johnson & Johnson vaccine has been administered so far amid an impasse over issues such as indemnity which has not been granted to either Serum Institute of India or Bharat Biotech. Notably, the Centre has already constituted a team to engage with vaccine makers Pfizer, Moderna and Johnson & Johnson for a speedy resolution.

The single-dose vaccine

While the Janssen vaccine 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 hospitalization 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. Besides the Janssen vaccine, the DCGI has also accorded emergency use authorization to Covishield, Covaxin, Sputnik V, and Moderna. 

COVID-19 vaccination in India

The vaccination drive is gaining pace with 13.45 crore jabs administered in July- a 12.5% increase against June's 11.96 crore inoculations. As per sources, 40 crore doses of COVID-19 vaccines will be available per month by October. This will be possible as a total of 7 vaccines are set to be available by October with Biological E's Corbevax, Zydus Cadila's DNA vaccine and Gennova's mRNA vaccine likely to get approval soon. A total of 44,49,37,560 persons have been inoculated whereas 12,66,57,103 of them have received the second dose of the vaccine too.