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SII vaccine gets nod, dry runs from today

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India was a step away from getting its first covid-19 vaccine after experts on Friday recommended granting emergency use authorization to Serum Institute of India’s (SII’s) Covishield, two people familiar with the development said, while the government prepared to roll out the shots as early as next week.

The independent subject expert committee (SEC) gave its recommendations to Drugs Controller General of India (DCGI) V.G. Somani for emergency licence for Covishield subject to certain conditions, the persons said, requesting anonymity. A formal clearance from the DCGI is likely to follow soon.

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Source: Company, govt announcement

As part of the conditions, SII has been asked for an updated factsheet, and the company can market the vaccine in two full doses at an interval of four to six weeks, according to one of the sources.

The approval for the mass use of the vaccine now turns the spotlight on the rollout, set to follow a priority list prepared by the Centre.

Health minister Harsh Vardhan on Friday chaired a high-level meeting to review preparedness at vaccination sites, and a trial run is set to take place on Saturday.

Health ministry officials briefed the minister on how they plan to make Saturday’s pan-India preparedness testing glitch-free. Vardhan said health officials should ensure that vaccination centres and those in-charge 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 comorbidities—by August. These groups are considered most at risk from covid.

Bharat Biotech International has also applied for an emergency licence for its indigenously developed Covaxin.

The SEC recommended “interim efficacy analysis for Covaxin”—developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), one of the persons said. The panel asked the Hyderabad-based drugmaker to expedite volunteer recruitment for its ongoing clinical trial.

While SII had submitted data from its phase 2 and 3 bridging study as well as that from AstraZeneca, it was not clear what data Bharat Biotech had submitted.

Bharat Biotech started its phase 3 study of 26,000 participants only in mid-November and, considering that the second dose is given 28 days later and the immune response happens two weeks after that, there is no clarity on the availability of its interim efficacy data.

The company’s phase 1 and 2 data involving a total of 680 participants showed Covaxin induced immunity against covid-19 through antibodies as well as T-cells and was safe with no serious adverse events related to the vaccine, as per pre-prints of the results that have not been peer-reviewed.

Covishield is SII’s version of the vaccine originally co-developed by AstraZeneca and the University of Oxford, while Covaxin is India’s first indigenously developed jab.

Both companies submitted their proposals to the DCGI for emergency licences early December, but the SEC had in its 9 December meeting asked the two companies to submit more data. SII was also asked by the panel to come after approval was granted by UK.

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