SEC clears Serum Institute vaccine with riders

  • Serum Institute had submitted its proposal for emergency licensure for the vaccine in early December, but the SEC had asked the company to return with updated data

Leroy Leo
Updated1 Jan 2021, 05:48 PM IST
Covishield is Serum Institute’s version of the vaccine originally co-developed by AstraZeneca and the University of Oxford.
Covishield is Serum Institute’s version of the vaccine originally co-developed by AstraZeneca and the University of Oxford.

NEW DELHI: A subject expert committee, tasked with vetting covid-19 vaccine proposals, has recommended emergency licensure for Serum Institute of India's Covishield, but subject to certain conditions, a source in the know told Mint.

A formal clearance from the Drugs Controller General of India (DCGI) V.G. Somani is likely to follow soon, the source said.

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Typically, the DCGI clears a proposal for approval or emergency licence only when it is recommended by the SEC.

However, Mint could not immediately ascertain the conditions that were placed on the company for marketing of the vaccine, and those are likely to be detailed only when a formal announcement is made.

Covishield is Serum Institute’s version of the vaccine originally co-developed by AstraZeneca and the University of Oxford.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) had on Wednesday given an emergency authorisation to AstraZeneca’s covid-19 vaccine for immunising people that are 18 years or older. The authorisation recommends two full doses administered with an interval of between four and 12 weeks, the Anglo-Swedish firm said.

Serum Institute had submitted its proposal for emergency licensure for the vaccine in early December, but the SEC had asked the company to return with updated data and after an approval was given by the UK MHRA to AstraZeneca for the original version.

The original version was co-developed by AstraZeneca and the University of Oxford, with AstraZeneca having the commercial rights.

At the time of publishing, there was no clarity on the SEC's decision on Bharat Biotech's and Pfizer's proposal, which are also under consideration for emergency licensure.

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First Published:1 Jan 2021, 05:48 PM IST
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