Virus World

NEW DELHI: The Drugs Controller General of India (DCGI) approved Bharat Biotech's Covid-19 recombinant nasal vaccine, health minister Mansukh Mandaviya tweeted on Tuesday. Notably, this will be India's first nasal vaccine for coronavirus. He took to Twitter, the health minister said, "Big Boost to India's Fight Against Covid-19! Bharat Biotech's ChAd36-SARS-CoV-S Covid-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against Covid-19 in 18+ age group for restricted use in emergency situation." "This step will further strengthen our collective fight against the pandemic. India has harnessed its science, R&D, and human resources in the fight against Covid-19 under PM @NarendraModi Ji's leadership," he added. He also said that we will defeat Covid-19 with a science-driven approach. "With the science-driven approach and Sabka Prayas, we will defeat Covid-19," he said. The regulator approved the vaccine for primary immunisation of those aged 18 years and above, for restricted use in emergency situations, Mandaviya added. The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had said.

It aims to inoculate some 300m people this year in one of the world's largest vaccination campaigns. The drugs regulatory authority gave the green light to the jabs developed by AstraZeneca with Oxford University and by local firm Bharat Biotech. Prime Minister Narendra Modi called it "a decisive turning point". India plans to inoculate some 300 million people on a priority list this year. It has recorded the second-highest number of infections in the world, with more than 10.3 million confirmed cases to date. Nearly 150,000 people have died. On Saturday India held nationwide drills to prepare more than 90,000 health care workers to administer vaccines across the country, which has a population of 1.3 billion people.  The Drugs Controller General of India said both manufacturers had submitted data showing their vaccines were safe to use. However, opposition politicians and some doctors have criticised a lack of transparency in the approval process.

Bharat Biotech's vaccine showed 81% efficacy in preventing symptomatic COVID-19 in an interim analysis of a late-stage trial in India, it said on Wednesday, a major boost for the shot shunned by some due to a lack of such data.  The positive result also brightens prospects for sales overseas, with the vaccine, India’s first successful homemade COVID-19 shot, already attracting interest from more than 40 countries, according to the firm. “COVAXIN demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” Bharat Biotech Chairman Krishna Ella said in a statement, referring to its vaccine. It said the analysis is based on 43 cases of COVID-19 patients who showed symptoms ranging from mild to moderate and severe, and of the total cases, 36 were from a placebo group, while seven were from those who received the vaccine. The results come as India struggles to convince its health and front-line workers to take the Bharat Biotech shot, which was approved in January without late-stage efficacy data.

Only about 11% of the more than 10 million Indians vaccinated had taken the Bharat Biotech shot as of last week, Reuters had reported. Many politicians in India, including Prime Minister Narendra Modi, have been inoculated with COVAXIN this week instead of a rival one developed by AstraZeneca Plc and Oxford University, as they seek to boost confidence in the locally developed vaccine. With more than 11 million infections so far, India is battling the world’s largest COVID-19 outbreak outside the United States. COVAXIN, which can be stored at normal refrigerator temperatures, is likely to be effective against the UK strain of the coronavirus, a study said in late January. The shot is an inactivated vaccine that introduces dead virus into the body to trigger an immune response.

Bharat Biotech is based in the southern Indian city of Hyderabad, a hub for drug and vaccine makers. It began operations in 1996, and has delivered over 3 billion doses globally of various types of vaccines, including ones for Hepatitis-B and typhoid. It is aiming to produce about 700 million doses of COVAXIN this year. The company, which signed a deal with Brazil to supply 20 million doses of the shot, said the next interim analysis will target 87 cases and the final analysis will be based on 130 cases. Its first interim analysis was based on a Phase III clinical trial involving 25,800 participants which was conducted with the Indian Council for Medical Research (ICMR), a federal government body. The trial included 2,433 participants who were older than 60, and 4,500 participants with co-morbidities. The trial results were evaluated by an independent data safety and monitoring board, the ICMR said in a separate statement.