WHO Demands More Data for India’s Covaxin Before Global Approval
On the 18th of October, the World Health Organisation (WHO) pushed back on India’s Bharat Biotech to supply additional information before granting an emergency‑use listing for the Covaxin COVID‑19 vaccine. The WHO “could not cut corners,” declaring that a thorough review is essential.
Background: A Quick Bang & a Long Look
- Bharat Biotech, partnered with a state research arm, started sending data to the WHO in early July.
- In January, India fast‑forwarded the vaccine to emergency use, even before the final phase three trial wrapped up.
- That late‑stage study later showed Covaxin to be only 78% efficacious, not a blockbuster figure but still worth a flight ticket!
Why a WHO Nod Matters
Without WHO’s blessing, the two‑dose Covaxin may find its passport stamped “not globally accepted.” That means millions of Indians who have already stepped under the shot could see their travel plans hit a snag.
Covaxin makes up 11% of the 985.5 million doses</b administered in India and has even seen exports. Picture that: 10 out of every 100 exported doors!
WHO’s Stance & What They Want
On Twitter, the WHO said, “We’re aware many are waiting for a recommendation, but we can’t cut corners.” The organization was looking for “one additional piece of information from the company today,” though details were left to the imagination.
India’s Vaccine Production Powerhouse
India is the world’s biggest vaccine factory, capable of producing over three billion COVID shots per year, mainly the AstraZeneca model.
Next Steps
WHO chief scientist Soumya Swaminathan announced that the technical advisory group will convene on 26 Oct to finalize the Covaxin listing. The goal: “to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere.”
As for Bharat Biotech’s response—so far, they’ve stayed quiet, but the world’s looking for those extra data points.
