Bharat Biotech International Ltd will publish its COVID-19 vaccine Covaxin's phase-3 trial results within a week, the government said. "I have been told that the company's phase-3 study will be published in the next seven to eight days. The data will be beyond what it had shared with the DCGI. It will be then peer-reviewed," Niti Aayog member (health) V.K Paul said at a briefing today.
Paul said that the government respects the US Food and Drug Administration's decision to reject the company's emergency-use authorisation proposal for Covaxin, and added that it does not have any impact on India's vaccine programme. "We are doing good on the regulatory front. There could be variations in scientific nuances among countries. We are satisfied with the vaccine, and it has no bearing on our programme," he said.
The US regulator rejected the company's proposal for emergency-use authorisation of Covaxin. It asked Ocugen Inc, the company's US partner, to apply for a biologics licence instead, which is a full approval. In a statement today, Bharat Biotech said that for a full licence approval, data from an additional clinical trial will be required to support the marketing application submission for Covaxin, which will extend the company's timelines for its launch in the US.
The company has been facing criticism from health experts for not making its Indian phase-3 trial data public. Its earlier deadline for sharing the results was June. According to a report by news agency Asian News International on Wednesday, the company had said that it would publish phase-3 trial results in July, and submit it to the Central Drugs Standard Control Organisation for a full licence application.
In April, the company had announced that the vaccine demonstrates overall interim efficacy of 78% against COVID-19. The company's vaccine is pending approval from the World Health Organization. Owing to this, Indian travellers who have been administered with Covaxin are being regarded as unvaccinated in several countries, as per reports. The company has sought the global health body's approval for emergency-use listing of Covaxin.US FDA rejects emergency use approval for Bharat Biotech's Covaxin - All you need to know
(To receive our E-paper on whatsapp daily, please click here. We permit sharing of the paper's PDF on WhatsApp and other social media platforms.)