Self-reliance has taken a backseat. The Centre has decided to allow entry of many foreign-made Covid-19 vaccines that have been listed by the World Health Organisation (WHO) or by other governments for restricted use.
Their import – which is expected to beef up the shortages -- was approved on Sunday by the National Expert Group of Vaccine Administration and accepted by the government on Tuesday.
Some of these vaccines have already been cleared by regulators in the US, Europe, Japan and the UK. These vaccines will now only require "post-approval bridging clinical trials. The idea is to build a “bridge” between a new region where a vaccine is introduced and the foreign place where it is already in use, and to ensure the vaccine’s safety and efficacy among the population in the new region.
So, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for mass immunization within the country.
The decision will facilitate quicker access to such foreign vaccines by India and would encourage imports, including import of bulk drug material. This will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability in the country, the ministry added.
On April 9, Congress leader Rahul Gandhi had shot off a 3-page letter to the Prime Minister for fast track approval of other vaccines as per norms and guidelines; Gandhi also wanted the state governments to have a greater say in vaccine procurement and distribution.
The Centre’s plan is to add to the basket of vaccines for domestic use and increase the pace and coverage of vaccination. Russian-made Covid vaccine, Sputnik V, has already been cleared for emergency use by the Drugs Controller General of India. Limited doses of the vaccine will be available by the end of this month or early next month.
Five more vaccines are expected to get approval this year. The list includes Johnson and Johnson (Bio E), Zydus Cadila, Serum's Novavax and a nasal vaccine from Bharat Biotech.
India had started the world's largest vaccination programme on January 16 and so far, more than 10 crore doses have been administered.
There are three vaccines in the WHO list —those by Oxford-AstraZeneca, Pfizer-BioNTech and Johnson & Johnson (J&J). The US FDA, too, has okayed three — those by J&J, Pfizer-BioNTech and Moderna. EMA has given four approvals — the three approved by the US and the one by Oxford-AstraZeneca. The UK has approved three — those by Pfizer-BioNTech, Moderna and Oxford-AstraZeneca. Japan has approved the one by Pfizer-BioNTech, while Oxford-AstraZeneca and Moderna have applied. So, India is looking at three new vaccines (those by Pfizer-BioNTech, Moderna and J&J).
