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With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is considering the united kingdom, which sources consider may give its nod to the Oxford COVID-19 vaccine following week, before deciding on giving emergency use authorisation to the Serum Institute that’s manufacturing the shots .
When the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the CDSCO will hold its assembly and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine, official sources said.
The practice of awarding emergency use approval for Bharat Biotech’s COVID-19 vaccine’Covaxin’ may take some time as its phase 3 trials are still underway, while Pfizer is yet to make a demonstration.
Serum Institute of India (SII) last week also had submitted some additional information required by the Drug Controller General of India (DCGI), the sources said.
Amid fears about the mutated variant of SARS-CoV-2 detected in the UK, government officials recently said that it will have no impact on the potential of emerging vaccines that are being developed in India and other countries.
The application by the Indian arm of US pharmaceutical company Pfizer wasn’t taken up for deliberation as the firm had sought more time for creating a presentation before the committee.
The Pfizer vaccine has already been approved by various countries including the UK, the US, and Bahrain.
While contemplating SII’s application, the SEC had recommended that the company should submit an updated safety data of period 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, in addition to the outcome of the evaluation of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for grant of EUA.
As for Hyderabad-based Bharat Biotech,”after detailed deliberation, 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 had said.
The SII has already manufactured 40 million doses of this vaccine, under the at-risk manufacturing and stockpiling licence from the DCGI, officials had stated.
