The DCGI Subject Matter Expert Committee has asked Bharat Biotech to provide more information on its Covaxin vaccine candidate.
Covishield, the Pune-based Serum Institute of India’s vaccine candidate, was approved by a Subject Matter Expert Committee (SEC) of the Controller General of Drugs of India (DCGI) on Friday night. Bharat Biotech has been asked to provide more data proving the efficacy of its candidate, Covaxin, as confirmed by an informed source. The Hindu.
The assent for Covishield came at the end of a marathon SEC meeting that began in the morning and lasted until late at night. The SEC makes its recommendation to the DCGI, which is the drug and vaccine approval authority.
“Covishield is likely to be practically available for use within the next week,” the source said. “As in the UK, we have approved the vaccine to be given in two doses 4 to 12 weeks apart.”
Covishield, which is similar to the ‘Oxford vaccine’ developed by the University of Oxford Vaccine Group and marketed by AstraZeneca, was approved by the UK health regulator under conditions of emergency use on Thursday. By virtue of this, the company is able to roll out its vaccines to priority groups and then to the general public, even if a full safety assessment has not been completed.
For Covishield’s assessment, the source said, the UK regulator’s assent and data from a phase 2 trial in 100 volunteers in India, antibody levels generated in volunteers in response to the vaccine, and safety data of phase 1 studies were based on agreeing to emergency use approval.
In the UK, it has been recommended that the vaccine be given in two doses 4 to 12 weeks apart. This, despite the fact that the performance of the vaccine was evaluated 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 allowed this after an increase in cases in recent weeks and decided to ensure that the maximum number of people receive at least one dose of a vaccine.
SII officials have said that India will have a reserve of 100 million doses from the first week of January, but it is unclear how many of these will be available to Indians. A longer dose interval means that potentially more Indians could receive at least a single dose of the vaccine.
Covishield is currently being tested in 1,600 volunteers as part of its phase 2/3 trial. However, the results of these trials have not been published or publicized in scientific journals.
“The phase 3 trial is ongoing and we will continue to review the data,” the person added. “Apart from the Chennai case of a reported serious adverse event from the vaccine, no other safety events have been reported. We also conclusively ruled out that this reaction was directly related to the vaccine. “
Preliminary efficacy data from India seemed to suggest that it was “similar” to what was observed in the UK and Brazil, which made up the bulk of the data set that the UK relied on for approval of the deal.
The Health Ministry had yet to comment on the approval granted, but a series of conditions under which the approval was granted will likely be specified on Saturday.
This is the second time in three days that the committee has met to review requests for emergency use approval from SII, BB and Pfizer India. The latter has reportedly searched longer, but the company’s mRNA vaccine has already been approved, under emergency use conditions, in the United States, United Kingdom, and prequalified by the World Health Organization.
Expectations that one of the candidate vaccines would be approved soon rose on Thursday after DCGI chief VG Somani indicated that a “New Year’s gift” was coming.
