Updated: September 16, 2021 7:14:06 am
TEST BATCHES of US pharma giant Johnson & Johnson’s single-dose Covid-19 vaccine have been sent to the country’s top testing laboratory in Himachal Pradesh by its Indian partner Biological E Limited, to pave the way for commercial production, The Indian Express has learnt.
However, top government sources said the government has still not granted indemnity against the cost of compensation for adverse side effects due to vaccination, as sought by Johnson & Johnson.
According to sources, talks on the indemnity issue are still pending, and commercial rollout of the single-dose vaccine is likely to place after a final decision is taken.
“Biological E had imported the bulk drug material, which they have made into test batches. These test batches need to be approved by the Central Drugs Laboratory, Kasauli. If the test batch gets approved, they will be ready for commercial production,” said a top government source.
On August 7, Johnson & Johnson was granted emergency use authorisation, paving the way for its Indian subsidiary to introduce the first single-dose Covid-19 vaccine in the country for commercial use.
Johnson & Johnson’s vaccine, developed by its subsidiary Janssen Pharmaceutical, recorded 85 per cent efficacy in its Phase 3 clinical trials. It was the second vaccine to be granted emergency use authorisation through a fast-track approval route by the Indian drug regulator.
On April 13, India changed its policy on regulatory approvals for foreign manufacturers to commercially market their Covid-19 vaccine, by waiving the pre-condition on conducting phase 2-3 clinical trials for vaccines that have been granted emergency approval by the US, EU, UK, Japanese regulators, including those listed by the WHO.
On June 29, US’s Moderna became the first foreign company to be granted emergency use approval for its mRNA vaccine under the liberalised regulatory regime.
There have been multiple rounds of discussions with Pfizer, Moderna and J&J on the supply of their vaccines in India.
However, the pharma giants, globally, have supplied their Covid-19 vaccines only after indemnities were given against the costs of compensation for adverse effects due to vaccination. In India, negotiations on the contentious indemnity clause are now in the final stages.
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