NEW DELHI: With preparations underway for a possible vaccine rollout before January, an Indian drug regulator is looking at the UK, which sources believe could give the vaccine a nod. Oxford Covid-19 next week, before deciding to grant an emergency use permit to the Serum Institute which manufactures the images here.
As soon as the UK drug regulator approves the Oxford vaccine, the expert committee on Covid-19 at the CDSCO will hold their meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations carried out. abroad and in India before granting any emergency permit for the vaccine here, official sources said.
The process of authorizing emergency use for Covid-19 Bharat Biotech ‘Covaxin’ vaccine may take some time as its phase 3 testing is still ongoing, while Pfizer has yet to make a demonstration.
“Going with this, the‘ Covishield ’Oxford vaccine appears to be the first to be released in India,” a source said.
The Serum Institute of India (SII) last week also submitted some additional data required by the General Drug Controller of India (DCGI), the sources said.
Amid fears about the variable release of SARS-CoV-2 detected in the UK, government officials recently said it will have no impact on the potential of emerging vaccines being developed in the UK. -India and other countries.
Bharat Biotech, the Serum Institute of India (SII) and Pfizer had filed an appeal to the Drug Controller of India (DCGI) seeking emergency use permit for their Covid-19 vaccines early this month.
The subject expert committee (SEC) on Covid-19 of the General Drug Control Agency (CDSCO) on 9 December sought additional safety and efficacy data for Covid-19 vaccines of SII and Bharat Biotech after considering the claims aca.
The claim by Indian branch of US pharmaceutical company Pfizer was not brought in for consideration as the company had sought more time to make a presentation before the committee.
The Pfizer vaccine has already been approved by a number of countries including the UK, USA and Bahrain.
While considering the SII application, the SEC had recommended that the company should submit updated safety data of level 2 and 3 clinical trials in the country, immunogenicity data from the UK and UK clinical trial. -India, together with the outcome of the evaluation of the UK Medicines and Healthcare products Regulatory Agency (MHRA) to provide EUA.
As Bharat Biotech was based in Hyderabad, “after detailed consideration, the committee recommended that the company should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration”, the SEC had say.
The Pune-based SII, the world’s largest manufacturer of vaccines, has partnered with Oxford University and AstraZeneca to produce the vaccine.
The SII has already made 40 million doses of the vaccine, under the manufacturing license and collection of endangered stock from the DCGI, officials said recently.
As soon as the UK drug regulator approves the Oxford vaccine, the expert committee on Covid-19 at the CDSCO will hold their meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations carried out. abroad and in India before granting any emergency permit for the vaccine here, official sources said.
The process of authorizing emergency use for Covid-19 Bharat Biotech ‘Covaxin’ vaccine may take some time as its phase 3 testing is still ongoing, while Pfizer has yet to make a demonstration.
“Going with this, the‘ Covishield ’Oxford vaccine appears to be the first to be released in India,” a source said.
The Serum Institute of India (SII) last week also submitted some additional data required by the General Drug Controller of India (DCGI), the sources said.
Amid fears about the variable release of SARS-CoV-2 detected in the UK, government officials recently said it will have no impact on the potential of emerging vaccines being developed in the UK. -India and other countries.
Bharat Biotech, the Serum Institute of India (SII) and Pfizer had filed an appeal to the Drug Controller of India (DCGI) seeking emergency use permit for their Covid-19 vaccines early this month.
The subject expert committee (SEC) on Covid-19 of the General Drug Control Agency (CDSCO) on 9 December sought additional safety and efficacy data for Covid-19 vaccines of SII and Bharat Biotech after considering the claims aca.
The claim by Indian branch of US pharmaceutical company Pfizer was not brought in for consideration as the company had sought more time to make a presentation before the committee.
The Pfizer vaccine has already been approved by a number of countries including the UK, USA and Bahrain.
While considering the SII application, the SEC had recommended that the company should submit updated safety data of level 2 and 3 clinical trials in the country, immunogenicity data from the UK and UK clinical trial. -India, together with the outcome of the evaluation of the UK Medicines and Healthcare products Regulatory Agency (MHRA) to provide EUA.
As Bharat Biotech was based in Hyderabad, “after detailed consideration, the committee recommended that the company should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration”, the SEC had say.
The Pune-based SII, the world’s largest manufacturer of vaccines, has partnered with Oxford University and AstraZeneca to produce the vaccine.
The SII has already made 40 million doses of the vaccine, under the manufacturing license and collection of endangered stock from the DCGI, officials said recently.