J&J set to begin India trial of its single-shot vaccine
US pharmaceutical giant Johnson & Johnson is in talks with the Indian government to soon begin clinical trials of its single-shot COVID-19 vaccine in the country, the company said on Friday. J&J has sent a letter to the Central Drugs Standard Control Organisation (CDSCO) saying it would shortly apply for permission to conduct trials in India, The Indian Express reported. Here are more details.
We are in discussions with government, confirms J&J representative
"We are in discussions with the (Indian 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 J&J representative said through email, according to Reuters. A bridging trial is where a country's regulator asks the firm to enroll around 1,000 participants to establish the safety and immunogenicity of a vaccine.
Development comes as India faces shortage of vaccines
The development is significant to India's COVID-19 vaccination program as the country struggles to battle a second wave of infections. Moreover, several Indian states including the worst-hit Maharashtra and the National Capital Delhi have been flagging a shortage of vaccines. However, the central government has repeatedly denied those claims saying that plenty of vaccine doses are still available.
J&J vaccine currently approved in the US, EU
The Johnson & Johnson single-dose vaccine is currently approved for use in the United States, the European Union (EU), and other countries like Thailand and South Africa. In India, the company has a deal with Biological E to manufacture its vaccine.
India currently has two approved vaccines in use
India currently has two approved vaccines in use - one developed by the Oxford University and the firm AstraZeneca and another developed by the Indian firm Bharat Biotech. Several other vaccine candidates are also undergoing trials in India including Russia's Sputnik-V and the vaccine developed by Cadila Healthcare Ltd. India has so far administered over 9 crore doses of the coronavirus vaccines.
The COVID-19 situation in India
India is facing an unprecedented second wave of the COVID-19 pandemic. The third worst-affected country in the outbreak on Thursday reported more than 1.31 lakh fresh infections, its biggest single-day surge, taking the nationwide tally to over 1.30 crore. India's death toll currently stands at over 1.67 lakh. Experts have blamed mutated coronavirus strains and laxity among people in following protocols for the resurgence.
