COVID-19 vaccines in India: Pfizer, Moderna move a step closer to approval as govt waives need for local trials

FPJ Web DeskUpdated: Wednesday, June 02, 2021, 11:44 AM IST
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Foreign-made COVID-19 vaccines such as those manufactured by Pfizer and Moderna on Wednesday moved a step closer to being approved for emergency usage in India. The Drugs Controller General of India has now done away with the requirement of local bridging trials for foreign vaccines that have already been approved by certain other health bodies and governments. As per the earlier requirements, vaccines that had undertaken clinical studies outside of India were required to hold a local trial.

According to a letter by DCGI chief VG Somani that was shared by news agency ANI, this was prompted by 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". The decision was taken based on the recommendations of the the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).

"It has been decided that for approval of COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL) and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of Country of Origin," read an excerpt from the letter.

This in turn means that both Pfizer and Moderna are no longer required to hold trials in India. Keep in mind however that the companies' request for indemnity or liability from compensation for any severe side effects remains unaccepted by the Centre.

But while it may be some time yet before the vaccines are made available in India, an India Today report suggests that the government might now be in favour of granting indemnity to foreign vaccine makers. The report quoted sources in the government to say that Pfizer had indicated it would be able to make doses available by July 2021.

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