American healthcare company Johnson & Johnson has received an Emergency Use Authorisation (EUA), paving the way for its single-dose Covid-19 vaccine to be available in India.

Health Minister Mansukh Mandaviya said with this, India had expanded its vaccine basket. “Now, India has 5 EUA vaccines,” he tweeted, referring to Bharat Biotech’s Covaxin, Serum Institute’s Covishield, Russian vaccine Sputnik V, Moderna’s vaccine (to be imported by Cipla) and now J&J.

Efficacy and safety

On the fast-track approval, J&J said the decision on EUA was based on efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated that J&J’s single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied. It also showed protection against Covid-related hospitalisation and death, beginning 28 days after the vaccination.

Both J&J and Moderna are early beneficiaries of the Centre’s fast-track approval process. Waiting in the wings is fellow-American company Novavax, which has a collaboration with Serum Institute.

Pfizer, the fourth US firm, was the first of the blocks in India. But talks on its vaccine seem to be deadlocked over indemnity. Even with J&J and Moderna, there is little clarity on how the indemnity issue has been addressed. Foreign vaccine-makers seek indemnity to protect them from local litigation.

J&J has an existing tie-up with Biological E for local manufacture of its vaccine, and reports indicated the latter would make 600 million doses annually. However, how many doses J&J will import, its distribution channels (through public or private hospitals) and its pricing remain unclear. J&J had globally indicated a $10 “non-profit” price for emergency use.

Side-effects

Last month, J&J had updated its Covid-19 vaccine factsheets to include information on the rare neurological case of Guillain-Barré syndrome. “Updates with this new information will be implemented in other regions of the world according to local regulatory procedures,”J&J said, after the United States Food and Drug Administration red-flagged the condition. Earlier, the European Medicines Agency had also warned about “very rare” instances of blood clots.

Anant Bhan, a researcher on global health, bioethics and health policy, said that doctors and vaccine recipients need to be told of these warnings, however small the risk may be. “India would have to look at all these data, as it’s the only data to go with,” he told BusinessLine .

While paving the way for fast-track approvals earlier this year, the Centre had outlined that the first 100 beneficiaries of the foreign vaccines would be assessed for seven days for safety outcomes before it is rolled out for further immunisation programmes.

 

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