It will still be mandatory for companies to conduct a bridging trial in India after the individual vaccines are given EUA.
The Ministry of Health and Family Welfare announced on Tuesday that it will fast-track the emergency-use authorisations given to foreign COVID-19 vaccines that have already been given approval in other countries. This is being done to widen the choice of COVID-19 vaccines available in the country, especially considering the steep surge in case numbers recently.
This move could also do speed up India’s inoculation drive, which is currently facing issues with the limited number of doses and choices available for people.
The new strategy was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) held on 11 April 2021. This recommendation has now been accepted by the Central government.
“Vaccination is one of the critical pillars of COVID control and management,” the health ministry said in a statement.
Many of the vaccines being developed and manufactured in foreign countries have already been granted authorisation by either US FDA, EMA, UK’s MHRA and Japan’s PMDA. Many have also been listed in WHO’s Emergency Use Listing.
These have now been given de-facto approval for testing in India. The ‘bridging trials’ for even these pre-approved foreign COVID-19 vaccines will still need to be conducted, according to the Second Schedule of the New Drugs & Clinical Trials Rules 2019. These trials can now be conducted with one less procedural challenge, making it easier for them to enter clinical trials in the Indian population.
A bridging trial is a supplementary clinical trial that is conducted in a new region, country to provide clinical data on efficacy, safety, dosage and dose regimen in that region. This will allow the new region that will allow extrapolation of the foreign clinical data to the new region.
As per the new announcement, the first 100 volunteers in the bridging clinical trial will be assessed and observed for seven days to monitor for the more severe and immediate side effects, after which it will be rolled for the entire country. This push to speed up the rollout of foreign vaccines comes as better quality data from clinical trials that include more and more people.
The health ministry believes that by doing this, India will gain faster access to foreign vaccines and “encourage imports” including that of bulk drug material and vials, to meet the domestic demand. Indian companies can now respond with suitable targets for manufacturing capacity, and with time, make more doses of the vaccine available for use.
The news comes after another big break in the Indian vaccination drive – the DCGI granting Russia’s Sputnik V emergency use approval in India. This makes Sputnik V only the third vaccine to be opened up for use in the drive.
Hyderabad-based Dr Reddy’s Labratories is already in the process of conducting bridging trials in India for the vaccine. Following a successful trial, Reddy’s will take on manufacturing and distribution of the vaccine. Sputnik V was developed with funding by the Russian Direct Investment Fund, which has signed agreements with Reddy’s and other manufacturers in India to produce 852 million doses of the vaccine in India in the months to come.