Serum Institute of India (SII) and Bharat Biotech have applied to the Central Drugs Standard Organization for emergency authorization of Covid vaccines.
Several mainstream media outlets reported that this emergency authorization was rejected by the Central Government.
The reports claimed that this was "decided in the meeting of the Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO) today."
The committee reviewed the applications of Pfizer, Serum Institute of India and Bharat Biotech. The Serum Institute of India had filed for emergency use authorization on Monday (December 7, 2020), while Bharat Biotech filed for the same on Tuesday (December 8, 2020).
The claim that the emergency authorization of COVID vaccines by SII, Bharat Biotech was rejected is MISLEADING.
Ministry of Health and Family Welfare, Government of India, took to its Twitter to reject this claim. Ministry rubbished the reports as fake.
According to the officials, an expert committee of the Central Drugs Standard Control Organization (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute of India and Bharat Biotech after deliberating upon their applications seeking emergency use authorization for the shots.
The emergency authorization of the COVID vaccine was not rejected, but additional data was sought in both cases.
While considering the Serum Institute's application, the subject expert committee (SEC) on COVID-19 has recommended that the firm should submit an updated safety data of phases 2 and 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) for grant of emergency use authorization.
For Hyderabad-based Bharat Biotech, the committee recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration.
"The SEC on COVID-19 of the CDSCO held a detailed deliberation on both the applications for around four hours. The recommendations by the SEC have been approved by the Drugs Controller General of India (DCGI)," an official source told PTI.
The committee reviewing the requests for emergency authorization of the COVID vaccines by SII and Bharat Biotech sought additional data about the vaccines, but has NOT rejected the request.
Hence, the claim is MISLEADING.