India was set to get its first vaccine against covid-19 after experts on Friday recommended granting emergency use authorization to Covishield from the Serum Institute of India (SII), two said. people familiar with the development, while the government prepared to roll out the vaccines as from next week.
The Independent Committee of Subject Matter Experts (SEC) has given its recommendations to Comptroller General of Medicines of India (DCGI) VG Somani for an emergency license for Covishield under certain conditions, the people said, asking for the ‘anonymity. A formal authorization from DCGI will probably follow soon.
As part of the conditions, SII has been asked for an updated information sheet, and the company may market the vaccine in two full doses at an interval of four to six weeks, according to one of the sources.
The approval of the massive use of the vaccine now highlights the rollout, which will follow a list of priorities established by the Center.
Health Minister Harsh Vardhan chaired a high-level meeting to review the readiness of vaccination sites on Friday, and a trial is scheduled for Saturday.
Health ministry officials have briefed the minister on how they plan to make Saturday’s pan-Indian preparation tests trouble-free. Vardhan said health officials should ensure that immunization centers and officials follow the detailed checklist and standard operating procedure prepared for them.
The government plans to inoculate 300 million people – 10 million healthcare workers, 20 million frontline workers and 270 million elderly and people with co-morbidities – by August. These groups are considered to be the most at risk for covid.
Bharat Biotech International has also applied for an emergency license for its locally developed Covaxin.
The SEC has recommended a “Interim Analysis of the Effectiveness of Covaxin” – developed by Bharat Biotech in conjunction with the Indian Council for Medical Research (ICMR), one of the people said. trial.
While SII had submitted data from its Phase 2 and 3 transition study as well as that of AstraZeneca, it was not clear what data Bharat Biotech had submitted.
Bharat Biotech began its Phase 3 study with 26,000 participants only in mid-November and, since the second dose is given 28 days later and the immune response occurs two weeks after that, there is no clarity on the availability of its intermediate efficacy data.
The company’s Phase 1 and 2 data for a total of 680 participants showed Covaxin-induced immunity to covid-19 through antibodies as well as T cells and were safe with no serious adverse events related vaccine, based on pre-impressions of results that have not been peer reviewed.
Covishield is the IBS version of the vaccine initially co-developed by AstraZeneca and the University of Oxford, while Covaxin is the first vaccine developed locally in India.
The two companies submitted their proposals to DCGI for emergency licenses in early December, but the SEC had, at its December 9 meeting, asked the two companies to provide more data. The panel also asked the SII to come after the UK approval.