09 Dec, 2020 6:57p.m.

Bharat Biotech & Serum Institute vaccines not considered for emergency use for lack of data


The expert committee of the Central Drugs Standard Control Organization has not cleared the COVID 19 vaccines of Serum institute and Bharat Biotech for emergency use in India. The applications were rejected on the grounds that there were not enough documents regarding safety and effectiveness. The companies were companies asked to submit more data on the trials.  Sources told that it was it was too early to say whether they would be rejected or accepted. The application for the Pfizer vaccine, which got approval in the UK was not considered today. 

The subject expert committee (SEC) of the CDSCO is learnt to have asked for updated safety data of phase-2 and phase-3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA).

However, the Serum Institute commented that this was just a normal procedure for the approval and the process could take another week or two. AstraZeneca which is developing the vaccine have told that the vaccine was 90 per cent effective in trials in the UK and Brazil.

It was on Monday, that the Hyderabad-based Bharat Biotech submitted its application for approval of the first Indian made vaccine, Covaxin, which is being indigenously developed in collaboration with the Indian Council of Medical Research (ICMR). Haryana Health Minister Anil Vij, who had received a first dose of the two doses of the Bharat Biotech's covaxin was tested +ve for the COVID 19. However the company clarified that that effectiveness can only be achieved if one takes two doses within 28 days.

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