India fast-tracks approval to foreign-made COVID-19 vaccines
The Indian government on Tuesday decided to fast-track the grant of Emergency Use Authorization (EUA) to COVID-19 vaccines that have been approved in other countries.
The government accepted recommendations made by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) during a meeting on Sunday to augment the "basket of vaccines" and accelerate the pace and coverage of India's vaccination drive.
Fast-tracked EUAs for vaccines approved by US, Europe, WHO, Japan
The NEGVAC recommended that COVID-19 vaccines developed in foreign countries that have been granted EUA by the USFDA, EMA, UK MHRA, PMDA Japan or have been listed in the WHO (Emergency Use Listing) may be granted emergency use approval in India, the Health Ministry said on Tuesday.
The NEGVAC mandated the requirement of post-approval parallel bridging clinical trials in place of local clinical trials.
'First 100 beneficiaries to undergo 7-day assessment before roll-out'
The Ministry said, "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 program within the country. The Union Government, after due consideration, has accepted the recommendation of NEGVAC."
'Move will facilitate quicker access to vaccines, encourage imports'
The Ministry described vaccination as "one of the critical pillars of COVID-19 control and management strategy."
"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."
India approves third vaccine: Russia's Sputnik V
On Tuesday, the Health Ministry also announced that the Drugs Controller General of India (DCGI) approved Russia's COVID-19 vaccine Sputnik V for restricted use in emergency situations.
Hyderabad-based Dr. Reddy's Laboratories—which has partnered with the Russian Direct Investment Fund (RDIF)—had applied for Sputnik V's EUA in India.
Limited doses of the vaccine—which is 91.6% effective—are going to be available by the end of April.
India saw marginal dip in infections today
According to the Union Health Ministry, as of Tuesday morning, India reported a total of 1,36,89,453 COVID-19 cases, including 1,71,058 deaths, 12,64,698 active cases, and 1,22,53,697 recoveries.
Over a single day, India added 1,61,736 new cases and 879 more fatalities, a day after a record single-day spike.
India is now recording more infections than any country, replacing Brazil as the second-worst-hit country on Monday.
10.8 crore vaccine doses administered across India
India had launched its vaccination drive on January 16 with two vaccines: Covishield (manufactured by the Serum Institute of India and developed by Oxford University and AstraZeneca) and Bharat Biotech's COVAXIN.
Only people aged over 45 are allowed to be vaccinated in India. Earlier, healthcare/frontline workers were also allowed to be vaccinated.
10,85,33,085 vaccine doses have been administered across India so far.