No approvals for Sputnik-V vaccine from SEC; seeks additional data

Sputnik-V: On Thursday, an expert panel from the Indian central drug authority seeks additional information from Dr. Reddy’s Laboratories. Earlier this month, the company seeks emergency use authorization for its COVID-19 vaccine Sputnik V.  The committee will take the decision after the company submitted the data related to the efficacy and interim safety of the vaccine in the next meet.

Moreover, the company on February 24th met the Subject Expert Committee (SEC) for emergency use of its COVID-19 vaccine. Whereas the company submitted the interim safety and immunogenicity data of its Gam-COVID-Vaccine, which is a combined vector vaccine generated in the country. Besides, the company also submitted the interim data from the ongoing Russian vaccine.

As per the sources, the Subject Expert Committee (SEC) was examined the reports for emergency use of authorization (EUA). After examining, the panel recommended submitting all immunogenicity parameters, unblinded data of serious adverse events, and RT-PCR positive cases, along with causality analysis reported till-date for further examination.

On the other side, the panel also asked the company to submit comparative results of Indian and Russian studies in Phase-III immunogenicity trails at various time points. It has also asked the company to submit the factsheet, as per the source.

“We had a meeting with the SEC for EUA recommendations and also awaits for the approvals from the central drug standard control organization (CDSCO). We will let you know once we received feedback from the organizations,” said Dr. Reddy’s Laboratories in a statement.

On February 19, the company approached the drug regulator (DCGI) for emergency use authorization (EUA) for Sputnik V. Last year, the drug-making company Dr. Reddy’s Labs made an agreement with the Russian Direct Investment Fund (RDIF) for conducting clinical trials of Sputnik-V in India.

Covid-19 Vaccines:

In India, the Drug Controller General of India (DCGI) approved two Covid-19 vaccines. Covaxin from Bharat Biotech and Covishield from Oxford-AstraZeneca manufactured by Serum Institute of India.

Whereas the Sputnik-V vaccine showed 91.60% efficacy in the phase-III clinical trials.

However, the shares of Dr.Reddy’s Laboratories Limited reported a bullish trend in the stock market. It gained 69.05 points with a 1.53% increase and reached 4,585.05 INR. While in BSE, the company gained 72.25 points with a 1.60% increase and reached 4,587.85 INR.