Corona Vaccine: Refusal on January 1, Two Ready! How did the expert panel decide on covaxine at the last minute?
In fact, last week, within 24 hours, an expert committee of the Drug Controller General of India changed its decision regarding cocaine. The Expert Committee approved the use of this biotech vaccine of Bharat Biotech by emergency without evidence of efficacy on humans. This big decision was taken in this meeting of the expert committee held on 1 and 2 January.
‘Indian Express’ Has published a detail report regarding the subject expert committee (SEC) meeting. According to the report, the SEC passed the prohibited use of covaxin on 2 January. The very next day i.e. on January 3, Dr. VK Somani, CDSCO of the Drug Controller General of India, approved the use of emergency on the candidate of covaxine.
Bharat Biotech Chairman and MD Dr. Krishna Alla on Monday amidst the ongoing politics on covaxine. Alla said that the politics is being done on the vaccine. He said that some people are gossiping about our vaccine. It should not happen. We are not just an Indian company but a global company.
Dr Krishna Alla criticized the critics, asking – ‘Why were such questions not raised on the data of the global trial of AZD1222, a version of the Covishield vaccine produced by Pune-based Serum Institute of India.’
In the SEC meeting on 1 January, it was told by Bharat Biotech that its covicin is capable of targeting the mutation of strains of corona virus. However, the company could not present enough data to substantiate its claim in the meeting. Therefore, the panel could not agree to approve the emergency use of this vaccine. However, on January 2, the SEC changed its decision and covaxine was approved to use emergency. The SEC recommended the emergency use of covaxine, citing efficacy data from a study on non-human heads.
The minutes of the SEC meeting in the public domain stated, ‘The data generated so far reflect a strong immune response (both antibodies as well as T cells) and in-vitro viral neutralization. A clinical trial running on 25,800 Indians is a big trial. It has already nominated 22,000 candidates with some conditions, which are still safe.
It was further stated in the meeting, ‘However, efficacy data is yet to come.’ In the meeting, the SEC panel said, ‘After detailed deliberations, the panel suggests Bharat Biotech to further accelerate the data of its vaccine. Also, in the already ongoing 3-stage hyun trial, more candidates are being asked to be included. The panel also recommended that the company have to file an interim efficacy analysis report on its application for approval of restricted emergency use.
However, in a re-convened meeting a day later, the SEC panel approved the emergency use of covacine made by Hyderabad-based company Bharat Biotech. The panel said that in view of the increasing incidence of newly muted corona virus infection, the Bharat Biotech vaccine could be used on a clinical trial mode of emergency.
The SEC said, ‘After the above deliberations, the committee has approved the emergency use of covicin as a comprehensive precaution and in public interest. Covaxin will be used in clinical trial mode. So that given the coronation mutations, we have more options for vaccination. Apart from this, Bharat Biotech will also continue the clinical trial of the third phase and will present it before the panel as soon as the final data is collected. ‘
However, Bharat Biotech head Dr Alla made it clear in his briefing on Monday that he had not yet submitted the interim efficacy data report to the panel. Alla said, ‘We have just given the data for the highest antibody response. In which long term immunogenicity and neutralization protection have been described.