NEW DELHI: The drug regulator’s Subject Matter Expert Committee (SEC) on the Covid-19 vaccine sought more time to analyze updated data submitted by the Serum Institute of India and Bharat Biotech for emergency use authorization (USA ) for their respective SARS vaccine candidates. CoV2. The committee will meet again on January 1 and is likely to take one last call to approve the vaccines, authorities said.
The development came on the heels of the UK Medicines and Healthcare Products Regulatory Authority (MHRA), which on Wednesday granted emergency use approval to Oxford-AstraZeneca’s Covishield vaccine, for which SII is a manufacturing and partner it is also conducting bridging studies in India. The UK approval raised hopes in India as it increased the chances of the vaccine being approved in India. Expectations rose even further after an urgent meeting of the SEC was called to consider US applications for Covid-19 vaccines.
“The committee has to analyze the data on the basis of which the company has received UK approval. In a situation like this, the regulator will have to make sure that the data presented in India is correlated with the global data, ”said an official.
“The additional data and information submitted by SII and Bharat Biotech was reviewed and analyzed by the SEC. Analysis of additional data and information is ongoing. The SEC will meet again on January 1, 2021 (Friday), ”said the government.
The government hopes to implement the vaccination campaign in January to inoculate around 30 million people in the first phase in July. IBS has stockpiled 40-50 million doses of Covidshield, the majority of which will likely initially arrive in India in the absence of the WHO prequalification required to export the vaccine to other countries.
The government is also conducting drills to ensure there are no gaps in the implementation of its mega vaccine management plan once the vaccine is approved and available for use.
In addition to SII and Bharat Biotech, the committee also considered Pfizer’s request for the US, but the company has requested more time.
The UK on Wednesday approved the Covid-19 vaccine developed by Oxford University scientists and produced by AstraZeneca for human use, the second coronavirus vaccine licensed for release in Britain after the Pfizer / BioNTech vaccine.
The development came on the heels of the UK Medicines and Healthcare Products Regulatory Authority (MHRA), which on Wednesday granted emergency use approval to Oxford-AstraZeneca’s Covishield vaccine, for which SII is a manufacturing and partner it is also conducting bridging studies in India. The UK approval raised hopes in India as it increased the chances of the vaccine being approved in India. Expectations rose even further after an urgent meeting of the SEC was called to consider US applications for Covid-19 vaccines.
“The committee has to analyze the data on the basis of which the company has received UK approval. In a situation like this, the regulator will have to make sure that the data presented in India is correlated with the global data, ”said an official.
“The additional data and information submitted by SII and Bharat Biotech was reviewed and analyzed by the SEC. Analysis of additional data and information is ongoing. The SEC will meet again on January 1, 2021 (Friday), ”said the government.
The government hopes to implement the vaccination campaign in January to inoculate around 30 million people in the first phase in July. IBS has stockpiled 40-50 million doses of Covidshield, the majority of which will likely initially arrive in India in the absence of the WHO prequalification required to export the vaccine to other countries.
The government is also conducting drills to ensure there are no gaps in the implementation of its mega vaccine management plan once the vaccine is approved and available for use.
In addition to SII and Bharat Biotech, the committee also considered Pfizer’s request for the US, but the company has requested more time.
The UK on Wednesday approved the Covid-19 vaccine developed by Oxford University scientists and produced by AstraZeneca for human use, the second coronavirus vaccine licensed for release in Britain after the Pfizer / BioNTech vaccine.
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