New Delhi, April 09:
Johnson & Johnson is in touch with the central government to start clinical trial of its much awaited single-dose COVID-19 vaccine in India, the company said on Friday, according to news agency Reuters. “We are in discussions with the (government) with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals,” a local J&J representative said, Reuters reported.
The COVID-19 vaccine developed US healthcare giant, has already been approved in United States, the European Union and other nations including Thailand and South Africa.
The news came amid some parts of India had faced a shortage of vaccine supplies. The central government, however, said there is no shortage of shots. At present, India is witnessing a second wave of COVID-19 infection.
On safety and effectiveness of J&J’s COVID-19 vaccine
Johnson & Johnson’s one-shot vaccine is ‘safe and effective’ against COVID-19 infection, US regulator earlier said. The vaccine was 72% effective in a US clinical trial, the USFDA mentioned. There were no COVID-19 related deaths in the vaccinated group, according to USFDA. The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA.
“The vaccine candidate was 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older,” Johnson & Johnson said earlier. The vaccine prevented 66% of moderate to severe cases of COVID-19, according to a company statement released earlier. Over 44,000 participants took part in the late stage trial of Johnson & Johnson’s coronavirus vaccine.
The phase III study of 45,000 people across 80 countries potentially included cases of new strains identified in South Africa and Brazil, US pharmaceutical’s chief financial officer said.
Will it be a game-changer for India’s COVID-19 vaccine drive?
The J&J shot delivers genetic instructions for human cells to create a specific protein of the coronavirus, in order to train the immune system for the live virus. The single-shot vaccine could go a long way toward ending the pandemic, experts said.
“A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance,” said Paul Stoffels, M.D., vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.
Separately, Johnson & Johnson has a deal with Indian firm Biological E Ltd to contract-manufacture its vaccine.
India currently has two approved vaccines in use, one developed by Oxford University and AstraZeneca and the other, a shot from local player Bharat Biotech. There are other vaccine candidates in trials in India including Russia’s Sputnik-V and a shot developed by Cadila Healthcare Ltd.