COVID-19 vaccines | Centre fast-tracks emergency approvals for foreign-made jabs

The Ministry of Health and Family Welfare announced on April 13 that it is fast-tracking approvals for foreign-produced COVID-19 vaccines that have been granted the Emergency Use Authorisation (EAU) in other countries. This is likely to help expand the basket of jabs available for domestic use and speed-up the nationwide vaccination exercise.

The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), in its meeting on April 11, recommended that vaccine candidates that have been developed and are being manufactured in foreign countries and which have been granted EUA by the USFDA, EMA, UK MHRA, PMDA Japan or those listed in the World Health Organisation (WHO)’s emergency use list, may be granted approval in India.

This recommendation by the NEGVAC was accepted after due consideration, the Union Government said.

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However, post-approval parallel bridging trial instead of conducting local clinical trials will be mandatory.

The first 100 beneficiaries of such foreign-made COVID-19 vaccines will be assessed for seven days before the doses are administered to others.

“This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilisation of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic,” the health ministry said in a statement.

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The Centre’s announcement came hours after the Drug Controller General of India (DCGI) approved the Sputnik V COVID-19 vaccine for emergency use. Russian-made Sputnik V is the third vaccine against the novel coronavirus to have been granted emergency use authorisation in the country after Covishield, developed by Oxford University-AstraZeneca and manufactured by the Serum Institute of India (SII), and Bharat Biotech’s Covaxin.

COVID-19 vaccines developed by Pfizer-BioNTech, Moderna and Johnson & Johnson, among others, currently do not hold an emergency use approval in India.

The decision is likely to attract these international vaccine makers to come to India as it offers a market of scale and a production hub for export to other countries. The move is especially likely to help Johnson & Johnson as its manufacturing facilities have already been identified and are ready.

This would allow Pfizer, Moderna and J&J to import vials or manufacture doses in India, according to a report by CNBC-TV18. However, foreign manufacturers will only be granted the EUA under this route and not the marketing authorisation.

As many as 10.85 crore doses had been administered in India as of April 13. However, several states have complained of supply shortage. The Centre and state governments have been pushing for eligible people to get vaccinated as soon as possible amid the second wave of COVID-19 cases in India.

The decision to grant emergency use approvals to foreign-made vaccines is likely to help speed-up the vaccination process as no clinical trial would be required. The bridging trial would happen concurrently with the vaccination exercise.