The Committee of Experts on DCGI Affairs asked Bharat Biotech to provide more data on its candidate vaccine Covaxin.
Covishield, the vaccine candidate for the Serum Institute of India, based in Pune, was approved by a Committee of Experts on the Subject (SEC) of the General Controller of Medicines of India (DCGI) on Friday night. Bharat Biotech has been asked to provide more data demonstrating the effectiveness of its candidate, Covaxin, an informed source confirmed to the The Hindu.
The nod to Covishield came at the end of a SEC meeting marathon that started in the morning and lasted until late at night. The SEC gives its recommendation to the DCGI, which is the drug and vaccine approval authority.
“Covishield is likely to be practically available for use next week,” said the source. “Similar to what happens in the United Kingdom, we approve the vaccine to be administered in two doses with an interval of 4-12 weeks.”
Covishield, which is similar to the ‘Oxford vaccine’ developed by the Oxford University vaccine group and marketed by AstraZeneca, was approved by the UK health regulator under conditions of emergency use on Thursday. As a result, the company is allowed to distribute its vaccines to priority groups and then to the general public, although a full safety assessment has not been completed.
For the Covishield assessment, the source said, the UK regulator’s assent and data from a phase 2 trial in 100 volunteers in India, the levels of antibodies generated in the volunteers in response to the vaccine and the safety data from the studies Phase 1 were considered to grant approval for emergency use.
In the United Kingdom, the vaccine has been recommended to be administered in two doses with an interval of 4-12 weeks. This, although the vaccine’s performance has been assessed in volunteers who received doses four weeks apart and it is still unclear how long the protective effect of a single first dose lasts. The UK regulator has allowed this after an increase in cases in recent weeks and has decided to ensure that the maximum number of people receive at least one dose of a vaccine.
SII officials said India will have a stockpile of 100 million doses from the first week of January, but it is unclear how many of them will be available to Indians. A longer dosage interval means that potentially more Indians could receive at least a single injection of the vaccine.
Covishield is being tested on 1,600 volunteers as part of its phase 2/3 trial. However, the results of these trials have not been published or published in scientific journals.
“Phase 3 testing is ongoing and we will continue to review the data on an ongoing basis,” added the person. “Apart from the Chennai case of a serious adverse event reported from the vaccine, no other safety events have been reported. We also conclusively excluded that this reaction was directly linked to the vaccine. “
Preliminary efficacy data from India seemed to suggest that it was “similar” to what was seen in the UK and Brazil, which formed the bulk of the data set that the UK depended on for approval of the agreement.
The Ministry of Health has not yet commented on the approval granted, but a set of conditions under which the approval was granted is likely to be defined on Saturday.
This is the second time in three days that the committee has met to review applications for emergency use approval by SII, BB and Pfizer India. The latter would have asked for more time, but the company’s m-RNA vaccine has already been approved, under conditions of emergency use, in the United States, United Kingdom and pre-qualified by the World Health Organization.
Expectations that one of the candidate vaccines would be released soon soared on Thursday after DCGI chief VG Somani indicated that a “New Year’s gift” was about to happen.