In what potentially comes as a piece of good news for Hyderabad-based vaccine manufacturer Bharat Biotech, the World Health Organization (WHO) has indicated that it might just provide its much-awaited approval to Covaxin, the company's indigenous jab against the coronavirus disease (Covid-19).
Soumya Swaminathan, the chief scientist at WHO, told a Mumbai-based news organisation that the final phase trial data for Covaxin "looks good" and meets the safety profile of the international public health agency so far.
The pre-submission meeting between Bharat Biotech and WHO was held on June 23, Swaminathan told CNBC TV-18 in an interview, adding that the data packet is currently being assembled. She noted that although Covaxin's efficacy against the Delta variant of Covid-19 is a bit low, it is still not bad, while the overall efficacy is "quite high."
Bharat Biotech finally made public its findings from the Phase-3 efficacy analysis of Covaxin last Saturday, where it claimed an overall efficacy of 77.8% against symptomatic Covid-19 patients. The pre-print data from "India's largest efficacy trial" showed that Covaxin demonstrates 93.4% effectiveness against severe symptomatic Covid-19 cases. On the other hand, Covaxin provides 65.2% protection against the B.1.617.2 (Delta) strain, currently the most predominant Covid-19 variant in India, it said.
The World Health Organization keeps a close watch on all the vaccines which are on the pipeline for emergency listing, Swaminathan said, adding that the agency is awaiting more data for a final say on the matter.
Speaking on the Covid-19 situation in India, the WHO chief scientist said that the government should focus on primary immunisation of at least 60-70% of its population. The focus should not be on booster shots but on broadening the scope of primary vaccination, she said. Only after a sizeable population has been vaccinated can India draw inspiration from countries like the United Kingdom, which have moved on to focusing on booster doses.
Most of the world, except some districts in the United States, has recently seen a spurt in Covid-19 cases while there has been no reduction in the death toll, Swaminathan noted.
Notably, Bharat Biotech's Covid-19 vaccine Covaxin has till now not found a place in the World Health Organization's emergency-use listing (EUL) of vaccines. The lack of endorsement from WHO has been hampering travel plans for individuals as many countries are only accepting vaccines approved by the public health body.
Covaxin is one of the three vaccines which are currently being used in India for inoculation of people against the coronavirus disease (Covid-19). The vaccine is developed by Hyderabad-based pharmaceutical company Bharat Biotech in association with the Indian Council of Medical Research (ICMR).
Serum Institute of India's Covishield and Russia's Sputnik V are the other two vaccines that have been administered to Indian citizens so far. Moderna's Covid-19 messenger RNA (mRNA) vaccine is expected to reach India this week, reported news agencies. However, discussions are still going on over indemnity waivers.