J&J In Talks With Centre For Trial of Single-dose Vaccine: Report
Johnson & Johnson has sent a letter to the CDSCO over initiating clinical bridging trials in India.
Amid some Indian states indicating an imminent vaccine shortage, US pharma giant, Johnson & Johnson on Friday, 9 April, confirmed that it is in talks with the Indian government to initiate a clinical bridging trial of its single-dose COVID-19 vaccine.
“We are in discussions with the Government of India to start a bridging study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals,” quoted ANI.
Johnson & Johnson has sent a letter to the Central Drugs Standard Control Organisation noting that it will soon conduct clinical bridging trials that would help the US giant market the vaccine in India, reported The Indian Express.
It has tied up with Hyderabad-based biopharmaceutical firm Biological E to expand manufacturing capabilities, added the report.
In a clinical bridging trial, there is a smaller participation ratio – usually around 1,000 –to test the safety and immunogenicity of the vaccine. India’s regulatory body needs the vaccine maker to conduct a clinical bridging trial for immunisation approval.
Johnson & Johnson has already tested the efficacy of the vaccine, which is reportedly 66 percent effective in preventing COVID-19. The vaccine was proven to be 72 percent effective against moderate and severe disease in the United States, the company said.
The vaccine, however, was found to be 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults. It has been approved for use in South Africa, Thailand, USA and Europe.
At least six states – Andhra Pradesh, Chhattisgarh, Haryana, Odisha, Telangana, and Maharashtra – have reported shortage of the Covishield vaccine, which is one of two COVID vaccines approved by the Ministry of Health and Family Welfare. Rajasthan CM, Ashok Gehlot, on 9 April, penned a letter to PM Modi indicating that the vaccine stock will finish within 2 days, and asked for another 30 lakh doses to be provided immediately.
Earlier, on Thursday, 8 April, ahead of PM Narendra Modi’s meet with chief ministers, Union Health Minister Harsh Vardhan tweeted that the Centre is continuously monitoring and enhancing vaccine supply, and there is no shortage of the vaccine, and nearly 2.4 crore doses are still available.
'Complete Protection Against Severe COVID'
J&J’s vaccine uses a common cold virus to introduce coronavirus proteins into cells and trigger an immune response, whereas the Pfizer/BioNTech and Moderna vaccines use a technology called messenger RNA, reported Reuters.
In the trial of nearly 44,000 volunteers, the vaccine was tested against multiple variants, and public health officials have recommended the use of it considering the vast spread of the pandemic.
The study showed the level of protection against COVID-19 varied from 72 percent in the United States, to 66 percent in Latin America. The concerning issue is that the efficacy has been proven to be only 57 percent in South Africa.
The vaccine was found to be 85 percent effective in preventing severe disease across all regions studied 28 days after vaccination in all adults. Efficacy against severe disease increased over time with no cases were reported among vaccinated participants after day 49.
The COVID-19 vaccine candidates demonstrated complete protection against COVID-related hospitalisation and death 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalisation, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO), with no reported cases among participants who had received the Janssen COVID-19 vaccine, 28 days post-vaccination, a statement on their website read.
(With inputs from The Indian Express and Reuters.)
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