India fast-tracks Emergency Approvals for foreign-made & approved COVID-19 vaccines

Amid a record surge in the number of COVID-19 cases reported across India, the Centre has decided to fast-track the Emergency Approvals for COVID-19 vaccines produced outside India that have been granted Emergency Utilisation Authorisation (EUA) in other countries in order to expand the domestic vaccine basket and increase the pace of vaccination.

Centre's move to fast-track the EUAs for COVID-19 vaccines manufactured aborad comes after Russia's Sputnik V received the SEC & DCGI's nod earlier on Monday and Tuesday for emergency use. The matter of augmenting the Basket of Vaccines available for fighting the pandemic as well as to accelerate the pace & coverage of domestic vaccination programme was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) held on 11th April 2021, chaired by Dr. V K Paul, Member (Health), Niti Aayog. The decision is expected to facilitate quicker access to such foreign vaccines by India & 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 release said.

As per a top government source's word to ANI, India will receive vaccines from 4 additional manufacturers by the third quarter this year, apart from the three so far. These include Johnson & Johnson's vaccine (with Biological E), Novovax (with SII, as mentioned above), Zydus Cadila's vaccine and an intranasal vaccine by Bharat Biotech.

Centre fast-tracks EUA for foreign COVID-19 vaccines produced & approved abroad

"The NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID-19, which have been developed & 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 as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019." 

"Further, 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", the government's press release read. 

DCGI approves Russia's Sputnik V vaccine

After the Subject Expert Committee (SEC) on COVID-19 on Monday recommended granting approval to Sputnik V for restricted emergency use, the Drug Controller General of India (DCGI) has now approved the use of Russia's Sputnik V vaccine against the COVID-19 virus. As per sources, around 10 crore doses of the Sputnik V vaccine are likely to be imported for emergency use in the country in the next six to seven months. Before the Sputnik V vaccine was approved, the DCGI had already granted emergency use authorisation to two COVID-19 vaccines –  indigenously developed Covaxin from Bharat Biotech, and Oxford-AstraZeneca's Covishield, manufactured by Serum Institute of India.

India reports 1,61,736 COVID-19 cases in 24 hours

A total of 1,61,736 new coronavirus infections have been reported in a day pushing India's tally of cases to 1,36,89,453, while the national COVID-19 recovery rate dropped further to 89.51 per cent, according to data updated by the Union Health Ministry on Monday. The death toll increased to 1,71,058 with 879 new fatalities, the data updated at 8 am showed. Registering a steady increase for the 34th day in a row, the number of active cases rose to 12,64,698, or 9.24 per cent of the total infections. The active caseload was at its lowest at 1,35,926 on February 12, 2021 and it was at its highest at 10,17,754 on September 18, 2020. The number of people who have recuperated from the disease surged to 1,22,53,697, while the case fatality rate has dropped further to 1.25 per cent, the data stated. India's COVID-19 tally had crossed the 20-lakh mark on August 7; 30 lakh on August 23; 40 lakh on September 5; and 50 lakh on September 16. It went past  60 lakh on September 28; 70 lakh on October 11; 80 lakh on October 29; 90 lakh on November 20; and the one-crore mark on December 19. According to the Indian Council of Medical Research (ICMR), 25,92,07,108 samples have been tested up to April 12, of which 14,00,122 were done on Monday.