India fast-tracks emergency approval for foreign COVID-19 vaccines

In a big boost to India's fight against coronavirus pandemic, the Centre on Tuesday decided to grant emergency use approval to all COVID-19 vaccines which have been developed and manufactured in foreign countries and have been granted emergency approval for restricted use by drug regulators in US, UK, Japan and Europe.

The vaccines which are listed in World Health Organization's (WHO) emergency use listing will also be granted emergency use approval in India. However, the vaccine makers will have to conduct a parallel bridging clinical trial instead of local clinical trial after the approval of the vaccines.

The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) in its meeting on April 11 "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," the Ministry of Health and Family Welfare said in a release.

The Centre, after due consideration, has accepted the recommendation of NEGVAC, it said.

The first 100 beneficiaries of such foreign vaccines will be assessed for seven days for safety outcomes before they are rolled out for further immunisation programme within the country.

The decision will make more vaccines available in the country amidst a second wave of coronavirus cases. India reported over 1.61 lakh new COVID-19 cases in the preceding 24 hours as on Tuesday morning. The COVID-19 vaccines manufactured and developed by Pfizer, Moderna and Johnson & Johnson are among those that have been granted approval in many foreign countries.

"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 etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic," the government said.

In January, India gave emergency use authorisation to Covishield, manufactured by the Serum Institute of India, and Covaxin, which is being manufactured by Bharat Biotech. Both the vaccines are being used in the country's vaccination campaign against coronavirus. India has cumulatively administered over 10.85 crore doses of COVID-19 vaccine as on Tuesday morning.

On Monday, the drug regulator also granted permission for restricted use in emergency situation to Russian COVID-19 vaccine Sputnik V.

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