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Shot in the Arm for India's Vaccine Drive as DCGI Exempts Post-Approval Bridging Trials

A beneficiary receives Covid-19 vaccine shot at a Covid-19 centre.

A beneficiary receives Covid-19 vaccine shot at a Covid-19 centre.

The move will fast-track the import of doses needed to bolster vaccinations as well as clear the way for the entry of vaccines such as Pfizer and Moderna.

In what could prove to be a shot in the arm for India’s vaccination drive against Covid-19, foreign jabs approved by specific countries and WHO for emergency use will not need bridging trials in India, the Drug Controller General of India (DCGI) has said.

The move will fast-track the import of doses needed to bolster vaccinations as well as clear the way for the entry of vaccines such as Pfizer and Moderna, who had requested the government for waivers like indemnity and post-approval local trials.

The exemption will, however, be limited to COVID-19 vaccines approved in India for restricted use in emergency situation which are already approved for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or listed in WHO Emergency Use Listing (EUL) and which are well established vaccine from the stand point that millions of individuals have already been vaccinated with the said vaccines.

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The government earlier required local clinical trials or bridging studies that involves testing the vaccine in Indian participants to assess the safety and immunogencity in the local population for vaccines developed overseas.

VG Somani, DCGI said the exemptions were given based on recommendation of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC).

“In light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines to meet the national requirements," Somani said.

Facing accusations of delay in placing orders for vaccines, the government has defended its vaccine procurement policy saying it has been pursuing Pfizer, J&J and Moderna since mid-2020 for the earliest possible imports, and has even waived local trials for well-established foreign vaccine makers. “Buying vaccines internationally is not similar to buying ‘off-the-shelf’ items," the government said in a statement titled ‘Myths & Facts on India’s Vaccination Process’.

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On allegations by some states that the Centre is not giving enough vaccines to the states, it pointed out that the Centre is allotting enough vaccines to the states in a transparent manner as per agreed guidelines. “The behaviour of some of our leaders, who in spite of full knowledge of the facts on vaccine supply, appear on TV daily and create panic among the people is very unfortunate. This is not the time to play politics. We need everyone to unite in this fight," the statement said.

India is currently using mainly two ‘made-in India’ jabs Covishield manufactured by the Serum Institute and Covaxin of Bharat Biotech and Russian-made Sputnik V at a smaller scale to inoculate its population, all of which are approved only for those aged 18 years and above.

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first published:June 02, 2021, 09:39 IST