The subject expert committee (SEC) on coronavirus vaccines has approved Bharat Biotech to conduct the second phase of trials for Covaxin, Mint reported. As part of the trial participants will get a third shot of Covaxin six months after the second dose.
The trial will be used to test the immune response provided by the vaccine against a disease in a person. Bharat Biotech's vaccine had shown 81 per cent efficacy in preventing symptomatic Covid-19 in an interim analysis of a late-stage trial in India.
In its phase 2 trial, which the firm started in August, it divided 380 participants into two groups, where one was given two doses of 3 mcg and another 6 mcg. In both groups, the two doses were given one month apart, Mint reported. Hiwever, it is not clear now why Bharat Biotech has modified the trial to test for a third dose six months after the second dose.
"COVAXIN demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants," said Bharat Biotech Chairman Krishna Ella in a statement, referring to its vaccine.
Health Minister Harsh Vardhan said on Friday both Covaxin and Covishied are completely safe and immunogenic and as of now, there are no concerns about the safety of these vaccines being used in the country. He said this at the India Economic Conclave while responding to the growing concerns surrounding Covishield after reports emerged of the vaccine causing blood clots.
Such cases are being examined by the respective governments of the countries where those have emerged. In India, all cases of adverse events following immunisation (AEFI) are monitored through a well-structured and robust surveillance system, Vardhan said.
Meanwhile, the Brazilian health regulator Anvisa has denied permission to import Covaxin into the country after its authorities found that the plant in which the vaccine is being made did not meet the Good Manufacturing Practice (GMP) requirements. Reacting to it, the city-based vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.
National Health Surveillance Agency Anvisa in its website said it received a request from the Brazilian Health Ministry to import 20 million doses of Covaxin. However a decision on that was suspended by the regulator due to the absence of some key documents.
"...considering the non-compliance with the requirements of Good Manufacturing Practices for Medicines, or the non-compliance with the petition procedures submitted for analysis, advocatedby current legislation,resolves: Refuse the Request (s) for Certification of Good Manufacturing Practices for Medicines of the company (ies) contained in the ANNEX," a Brazilian government gazette said on March29.
Dear Reader,
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.
Digital Editor
RECOMMENDED FOR YOU