After India granted permission to Russia made Sputnik V vaccine for emergency use, moves are afoot to widen the ambit of Covid-19 vaccine basket by giving approval to more jabs manufactured in countries like the US, the UK, Japan.
Meanwhile, the Centre on Tuesday maintained that there was no vaccine shortage given that over 1.67 crore Covid-19 vaccine doses were still available with States and UTs and the main problem was that of better planning.
Addressing a Press conference here, Union Health Secretary Rajesh Bhushan said so far States and UTs have received 13,10,90,370 vaccine doses, out of which the total consumption, including wastage, has been 11,43,69,677. “As per 11 am data, unutilised doses available with States and Union Territories for administration is 1,67,20,693. From now till April end, 2,01,22,960 doses are in supply pipeline to states and UTs,” he said.
Vaccines on the WHO’s emergency use list will also be part of this opening up with an aim to meet the growing demand for Covid-19 surge following a surge in infections in the country.
Presently, Covishield and Covaxin developed by Oxford University-AstraZeneca and manufactured by Serum Institute of India (SII) and Bharat Biotech International Ltd (BBIL) respectively are provided under the nationwide vaccination programme launched on January 16.
Now the Government has accepted the recommendation of an expert panel which said that Covid-19 vaccines which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by authorities in the US, Europe, the UK, Japan or which are listed in the WHO Emergency Use Listing, may be granted emergency use approval in India.
The expert panel also mandated the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial.
According to the Union Health Ministry, 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 DCGI gave its nod for the emergency use of Sputnik vaccine based on recommendations of the Subject Expert Committee. The interim results of safety immunogenicity and efficacy from Russian Phase-III clinical trial have been published in Lancet journal.
The decision to give nod to more jabs aims to facilitate quicker access to such foreign vaccines. It would also encourage imports, including that of bulk drug material, and help in 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, said sources in the Union Health Ministry.
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 VK 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 have already received approval for “restricted use by USFDA, EMA, UK MHRA, PMDA Japan may be granted emergency use approval in India”.
It is understood that the “vaccines, which are listed in the World Health Organization’s (WHOs) emergency use listing, may also be granted emergency use approval in India”.
The Central Government, after due consideration, has accepted the recommendation of NEGVAC, said a statement from the Ministry of Health and Family Welfare.
