MUMBAI: US major Johnson & Johnson reiterated on Monday that it remains committed to bringing its single-dose Covid-19 vaccine to the country, and is still in talks with the government, dispelling confusion on its India plans.
The Subject Expert Committee (SEC) under India’s drug controller had noted in its meeting held on July 29 that the company had withdrawn its proposal, according to minutes of the meeting accessed by TOI.
When contacted, the company clarified that it has withdrawn its application from Drugs Controller General of India (DCGI) for conducting local studies as there is no requirement to do so any longer. It is, in fact, close to a decision on finalising its plans, it added.
“We look forward to ongoing discussions with the government of India and will continue to explore how to accelerate availability of the Johnson & Johnson Covid-19 vaccine in India,” the company official told TOI.
Though the policy tweak to facilitate the entry of imported vaccines was announced in April, there has not been progress in the launch of any foreign-made vaccines, so far.
Talks with foreign companies — Pfizer, Moderna and Johnson & Johnson, have been on for months, but there is no decision by the government yet on granting the manufacturers indemnity from lawsuits.
Around 11% of the country’s adult population has been immunised with both doses of the vaccine till July.
Faced with huge vaccine shortages in the midst of a massive surge in Covid-19 cases, the government had decided in April to fast track approvals for foreign-produced Covid-19 vaccines authorised by major global regulators.
According to the new policy, vaccines approved by Western regulators including the USFDA, UK’s MHRA & WHO will be granted emergency authorisation, with the company conducting post-approval parallel bridging studies, in place of prior local clinical trials.
Last year, the US company had tied up with Hyderabad-based Bio E for manufacturing the Covid-19 vaccine.
“We are exploring how best to accelerate our ability to deliver our vaccine to the people of India through our global Covid-19 vaccine supply network, including our partnership with Biological E Limited. We believe Biological E will be an important part of our network, where multiple manufacturing sites are involved in the production of our vaccine across different facilities, sometimes in different countries and continents, before the vaccine can be distributed,” the official added.
There is not much clarity yet on the launch of the vaccines.