Following months of speculation, the World Health Organization (WHO) has granted Emergency Use Listing (EUL) to Covaxin , manufactured by Bharat Biotech. This now allows the vaccine’s better availability in many more countries, particularly via global groupings such as Covax. One of WHO’s key aims is to have at least 40% of people in all countries vaccinated by the year-end — a tall order as the latest estimates suggest that only around 1% of people in low-income countries have received their jabs. Seventy countries are yet to vaccinate 10% of their populations, and 30 countries — including much of Africa — have vaccinated fewer than 2%. In Latin America, only one in four of the population has received a vaccine dose, according to The British Medical Journal . Covaxin is an indigenous, inactivated whole-virion vaccine that has been developed based on well-established protocols. This has meant that it was put on the regulatory speed belt at nearly every stage, the most significant being its emergency approval by India’s drug regulators without any published phase-3 efficacy data. The ostensible reason for the haste was that India needed a low-cost indigenous vaccine that could be quickly administered to many.
Though Bharat Biotech has years of experience in producing crores of vaccines, the scale of quickly ramping up Covaxin supply has so far been beyond its capacity. In no month, since July, has Bharat Biotech actually delivered on its promised supply of vaccine, and even after over 107 crore shots have been administered, only around 12% have received Covaxin; many in India have been vaccinated with Covishield. Moreover, before the Centre agreed to take over 75% of the public supply, Covaxin offered no cost advantage — and in some instances was costlier — than Covishield. Bharat Biotech however moved to quickly get WHO’s approval for its vaccine under its emergency listing process, in July. But unlike the rapid-fire clearance by India’s Central Drugs Standard Control Organization, WHO’s evaluation process has turned out to be considerably more involved. WHO cleared the AstraZeneca (Covishield) vaccine in four weeks but that Covaxin has required over 20 weeks — especially in a climate where much of the world is desperate — raises several questions. Bharat Biotech is no novice to WHO’s clearance process and would surely be aware of all the requirements. While Covaxin’s EUL may now ease foreign travel for a fraction of Indians, there is a real need to know why, in spite of Bharat Biotech’s claims that it had furnished the required data whenever demanded, this approval took the time it did. With Covaxin close to being approved for children there will be significant demand now for this population segment; however, the company must work to improve its manufacturing supply and contribute to a larger share of the vaccines globally administered.