Johnson & Johnson Friday said it has submitted an application to the Indian drug regulator to conduct a study of its COVID-19 vaccine in adolescents aged 12-17 years.
The US-based pharmaceutical company noted that it is committed to facilitating global equitable access to its COVID-19 vaccine and recognise the unmet needs of children.
“On 17 August, 2021, we submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of the Johnson & Johnson COVID-19 vaccine in India in adolescents aged 12-17 years,” a J&J India spokesperson said in a statement.
Why is this relevant?
If granted the due approval, this will be the third vaccine candidate to be tested on adolescents in India. However, Indian manufacturers Bharat Biotech and Zydus Cadila have already beat J&J in that race.
Earlier today, Zydus Cadila’s ZyCov-D was granted emergency use approval for vaccinating those aged 12 and above. Bharat Biotech’s Covaxin, on the other hand is also in the final stages of its clinical trial for children as young as 2 years of age, and has shown ‘promising results’. It expects to be ready for approval and roll out by next month.
To ultimately achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials continue to move forward not only in adults but in the adolescent and infant population as well.
Furthermore, J&J vaccine’s single-dose regimen and a higher tolerance for temperature could also boost the availability of the shots even in remote parts of the country. This gains in significance given that the country has recently been criticised for its slow pace of vaccination.
Is J&J vaccine also available for adults?
Earlier this month, the government had given Emergency Use approval to J&J’s single-dose COVID-19 vaccine in India.
While announcing the approval, Union Health Minister Mansukh Mandaviya had said the approval would further boost the country’s collective fight against the novel coronavirus infection.
The six vaccines granted Emergency Use Authorisation in India are Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Zydus Cadila’s ZyCov-D, Moderna, and J&J.
How is it different?
Unlike its US counterparts, Moderna and Pfizer vaccines, the Johnson & Johnson vaccine does not use messenger RNA (mRNA) to help the body build its defenses against the virus. Instead, it is an adenovector vaccine like the Oxford-AstraZeneca vaccine.
In this case, the gene of the coronavirus’ signature spike protein is added to an adenovirus, a common virus that causes colds or flu-like symptoms, which when introduced into the body, delivers the instructions that teach human cells to make the spike protein. That causes the immune system to react by making antibodies to attack the spike protein, so if the person is exposed to COVID-19, the immune system is ready to fight it. It must also be mentioned that the adenovirus is modified so it can enter cells but cannot replicate or cause illness.
How does it fare?
- Johnson & Johnson vaccine is currently the only vaccine, which is effective after only one dose. Authorities can use this vaccine on people who may be hard to reach or who are otherwise unlikely to get a second dose.
- Unlike all Indian vaccines, which have to be stored at 2-8 degrees Celsius, the Johnson & Johnson vaccine can be refrigerated for up to three months at normal temperatures. This would allow the government to send these stocks to rural parts of the country where the cold chain may not be well developed.
- Johnson & Johnson said a study showed the vaccine was 85 percent effective against “severe/critical disease and demonstrated protection against hospitalisation and death”.
- The vaccine was effective across regions studied globally, including in South Africa and Brazil, “where there was a high prevalence of rapidly emerging Beta and Zeta (P.2) variants during the study period”, according to the company.
- The vaccine was 66.3 percent effective in clinical trials (efficacy) at preventing laboratory-confirmed COVID-19 infection in people who received the vaccine and had no evidence of being previously infected.
- A single dose of the vaccine generated neutralising antibodies against a range of Sars-CoV-2 variants of concern, including against Delta (B.1.617.2), Beta (B.1.351), Gamma (P.1).
The vaccine was one of the early candidates to have been cleared by the US Centers for Disease Control, and Prevention (US CDC) and was said to have high efficacy at preventing hospitalisation and death in people. But the vaccine has run into one hurdle after another, notwithstanding the promising trial results.
For instance, On 13 April, the US government paused the administration of the vaccine to investigate a few cases in which people experienced blood clots after receiving the vaccine. All of the cases emerged within two weeks of vaccination. But on 23 April, US health officials lifted the pause after scientific advisers decided the vaccine’s benefits outweigh the risks.
Again, earlier in the month social media users shared posts, which claimed that the vaccine contains aborted fetal DNA as an ingredient, to which the Roman Catholic Archdiocese of New Orleans released a statement calling it “morally compromised”. It was later clarified that while the vaccine used lab-replicated fetal cells during its production process, the vaccine itself does not contain any fetal cells.
Besides, as per recent reports, the vaccine increases the risk of Guillain-Barré syndrome during the 42 days following the vaccination. While the vaccine has not been proven to be a causative effect of the disorder, influenza and shingles vaccines have been linked to an increased risk of contracting the syndrome.