Amid the exponential surge in Covid-19 cases, India is mulling to allow vaccines manufactured in countries like the US, the UK, Japan or which are listed in the WHO’s emergency use listing.
The aim is to augment the basket of vaccines available for fighting Covid-19 pandemic as well as to accelerate the coverage of domestic vaccination programme started on January 16.
The decision will facilitate quicker access to such foreign vaccines and would encourage imports, including of bulk drug material, and optimal utilisation of domestic fill and finish capacity, which will, in turn, provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic use.
The matter was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) chaired by Niti Aayog’s Member (Health) Dr V.K. Paul, on Sunday amid the surge in Covid cases in the country which so far has infected 1,36,89,453 people and claimed 1,71,058 lives.
After comprehensive deliberation, the NEGVAC recommended that vaccines for Covid-19 being manufactured in foreign countries as well as those which are already have received approval for “restricted use by USFDA, EMA, UK MHRA, PMDA Japan may be granted emergency use approval in India”.
It is learnt that the “vaccines, which are listed in World Health Orgnisation’s (WHOs) emergency use listing, may also be granted emergency use approval in India”.
The approval may be granted 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 and Clinical Trials Rules 2019”.
Further, it is decided in the meeting, 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 programme within the country.
The Central government, after due consideration, has accepted the recommendation of NEGVAC, said a statement from Ministry of Health and Family Welfare.
In its approach to tackle Covid-19 pandemic in a proactive and pre-emptive manner, India set up a task force headed by the Principal Scientific Advisor to encourage research and development for vaccine manufacture as early as May 2020. In August last year, an Expert Group headed by Paul was also established to assist in roll out of the Covid vaccination programme.
The countrywide vaccination drive started from January 16. Two “Made in India” vaccines have been approved for Emergency Use Authorisation (EUA) by national regulator, the Drugs Controller General of India (DCGI). These are “Covishield”, developed by Oxford University-AstraZeneca and manufactured by Serum Institute of India (SII) and “Covaxin” developed and manufactured by Bharat Biotech International Ltd (BBIL).
Earlier in the day, India also granted permission for third Covid-19 vaccine ‘Gam-COVID-Vac’ combined vector vaccine, popularly called Sputnik-V, in emergency situations.
The DCGI gave its nod for the emergency use of the vaccine based on recommendations of the Subject Expert Committee.