Centre fast-tracks approval for foreign-made Covid vaccines
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country.
Published: 13th April 2021 02:08 PM | Last Updated: 13th April 2021 08:16 PM | A+A A-
NEW DELHI: In a major decision that will pave the way for quicker access of a number of Covid-19 vaccines in the country, India has decided to fast track emergency approvals for foreign-produced coronavirus vaccines that have been granted restricted use permission in other countries.
The decision comes amidst a massive surge of Covid-19 infections in the country that has now surpassed the first peak of the pandemic India witnessed last year.
The emergency decision by the government however still maintained the fig leaf of bridging trial, as experts pointed out, by maintaining that the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programmes within the country.
Nonetheless, the relaxation in existing rules makes it easier for Covid-19 vaccines by Pfizer, Moderna, Johnson & Johnson and Novavax to apply for emergency use in India even though those have not been tested in the Indian population.
The announcement on foreign-made vaccines comes after the National Expert Group on Vaccine Administration for COVID-19, recommended that vaccines, which have been developed & are being manufactured in foreign countries and which have been granted emergency approval for restricted use in the USA, UK, European Union or Japan or which are listed in World Health Agency emergency use listing may be granted emergency use approval in India.
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The panel however also mandated the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under the second schedule of the New Drugs & Clinical Trials Rules 2019.
The matter related to fast tracking the emergency approvals for foreign-produced Covid-19 was discussed in the 23rd NEGVAC meeting on Saturday, chaired by V K Paul, member (health), Niti Aayog, said the Union health ministry
“This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity,” ministry added in a statement.
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Authorities however maintained that it may be several weeks before any of the foreign-made vaccines are available for public use in the country and will also depend on interest shown by international vaccine makers.
Many experts have long been saying that Covid-19 vaccines being used by developed elsewhere that have completed efficacy trials should be included in the country’s Covid immunisation drive.
“The Indian regulator should consider approving other vaccines that have finished efficacy trials elsewhere and have partnerships with Indian vaccine companies – for example, Johnson & Johnson, Sputnik V and Novavax,” virologist Shahid Jameel had said a couple of weeks back.