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Centre set to fast-track approvals for foreign-made Covid-19 vaccines

Our Bureau New Delhi | Updated on April 13, 2021

This government’s decision will help India to quickly access foreign-made vaccines   -  Dado Ruvic

Could benefit jabs from J&J, Novavax, Pfizer and others

With Covid showing no signs of receding and States reporting vaccine shortages, several foreign-made shots could be in line to get regulatory approval quickly as the government has decided to fast-track approvals.

The Union Health Ministry said on Tuesday that the Centre has decided to give emergency use approval to vaccines developed or manufactured overseas if they have a clearance for restricted use from regulatory authorities in the US, the UK, the European Union and Japan, besides those listed by the World Health Organization.

The vaccines waiting in the wings would include those from Johnson & Johnson (that has a tie-up with India’s Biological E), Novavax (with a tie-up with Serum Institute) and Pfizer. The other globally approved vaccine is from Moderna, but it does not have an alliance partner or a presence in India. Such is also the case with Chinese vaccines.

“This decision will help in facilitating quicker access to such foreign vaccines by India and would encourage imports including 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,” the Health Ministry said.

US pause on J&J vaccine

The decision to fast-track approvals comes even as the US health authorities have recommended a pause on J&J’s vaccine, following reports of rare blood clots in young recipients.

The first 100 beneficiaries of the foreign (approved) vaccines would be assessed for seven days for safety outcomes before they are rolled out for further immunisation programmes within the country, the Ministry said in a statement.

The decision comes after the Drugs Controller General of India (DCGI) approved Russia’s Sputnik V for emergency use on Monday.

Responding to the government fast-tracking decision, a Pfizer company spokesperson said, “We have noted the recent announcement with regard to the regulatory pathway for global vaccines. We remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government’s immunisation programme in the country.” Pfizer had taken itself out of the process to get an emergency approval, after the government wanted it to undertake local trials.

NEGVAC recommendation

The Centre’s latest decision comes after the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), chaired by VK Paul, Member (Health), NITI Aayog, recommended that vaccines for Covid-19, which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by the USFDA, the EMA, the UK MHRA, the PMDA Japan or which are listed in WHO (Emergency Use Listing) be granted emergency use approval in India.

Meanwhile, the Department of Biotechnology has approved additional funding for clinical studies of India’s ‘first of its kind’ mRNA-based Covid-19 vaccine, HGCO19.This vaccine has been developed by Pune-based Gennova Biopharmaceuticals Ltd.

Published on April 13, 2021

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