With surging Covid-19 cases fuelling calls for faster vaccination, the Centre enabled faster access to foreign-made vaccines by doing away with bridging trial studies prior to grant of emergency authorisation for shots approved by recognised regulators like the US FDA or UK’s MHRA.
The changes in regulatory approvals are intended to increase availability of jabs amid a steep second wave of the infection. The vaccines can be imported in ready-touse vials or in a fill-and-use form, health secretary Rajesh Bhushan said. Vaccines granted emergency approval by drug regulators of the US, the EU, Japan and the UK or those listed with WHO for emergency use will be given the exemption.
There will, however, be post-approval parallel bridging clinical trials in the Indian population for such foreign vaccines. Further, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before a wider rollout for the immunisation programme, the health ministry said. The government said it would carry out price and supply negotiations with vaccine makers.
The decision to facilitate quicker access to foreign vaccines is expected to encourage imports, including import of bulk drug material, optimal utilisation of domestic fill and finish capacity which will, in turn, provide a fillip to vaccine manufacturing capacities and availability for domestic use, the government said. The decision to do away with pre-approval bridging studies is understood to reflect both the urgency of the situation and evaluation of evidence that many vaccines are doing well with millions of people having received the shots.
“The National Expert Group on Vaccine Administration for Covid-19, after comprehensive deliberation, 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 USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019,” the health ministry said.
“The decision has created an enabling regulatory provision to enable those foreign-made Covid vaccines that have been approved by credible foreign regulators,” the ministry said, underlining that it denotes streamlining and fast-tracking of the regulatory system to increase availability and accessibility. Meanwhile, makers of Russian vaccine Sputnik V welcomed emergency use approval by India, saying 60 countries had allowed use of the shot that is seen to deliver 91% efficacy. Russian sovereign wealth fund RDIF said deals were in place with Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech for manufacture.
So far, India has granted emergency approval to three vaccines for restricted use. While Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield are part of the national vaccination drive, the recently approved Sputnik V will be initially imported for distribution before local manufacturing begins.
While Covaxin, being a locally developed vaccine, is undergoing full clinical trials in India, bridging studies to check safety, efficacy and immunogenicity in local population were conducted on both Covishield and Sputnik V before grant of emergency use authorisation.