In clinical trial mode, Bharat Biotech vaccine got approval: ICMR.
Key points:
- On Tuesday, (ICMR), has said the Covid-19 vaccine from Bharat Biotech was cleared in clinical trial mode.
- Industry experts and also some opposition leaders have raised concerns about the lack of data on Covaxin from the Phase 3 trial.
- On Tuesday, the Union Ministry of Health said it was prepared to carry out the Covid-19 vaccine around 10 days.
- Rajesh Bhushan even said that healthcare, as well as frontline staff, do not need to register for the vaccination drive.
On Tuesday, Balram Bhargava, Chief of the Indian Council of Medical Research (ICMR), has said the Covid-19 vaccine from Bharat Biotech was cleared in clinical trial mode, which indicates that participants have to agree. He addressed the questions posed about the clearance given to Covaxin.
Balram Bhargava during Tuesday press conference:
“Permission for limited use in clinical trial format has been granted, which means that participant consent has to be taken as well as participants have to be followed up on a regular basis,” Bhargava said that at a Tuesday press conference.
“Explaining the method followed by the granting of a nod to the Covid-19 vaccine from AstraZeneca-Oxford University and the indigenous development of Covaxin, Bhargava added, “The current pandemic situation, high mortality, available science but lack of conclusive treatments were regarded by the CDSCO Subject Expert Committee (SEC) on Covid-19 for the granting of accelerated authorization for these vaccines, and that is in our case.
Covishield and Covaxin approved by WHO:
At Sunday, the Drugs Controller General of India (DCGI) authorized AstraZenca’s Covishield vaccine, developed by the Serum Institute, including Covaxin for the country’s limited emergency use, paving the way for a major inoculation campaign.
Industry experts and also some opposition leaders have raised concerns about the lack of data on Covaxin from the Phase 3 trial. The critics warned that in India, “sidestepping” procedures and giving “premature” clearance could endanger lives and fuel vaccine hesitation.
SEC guides the DCGI in the process of decision making:
In a pandemic scenario, minimal use is considered based on evidence on protection and immunogenicity, although the clinical route of phase three is still underway. A surrogate for efficacy is the immunogenicity data produced through phase two clinical trials.
To direct acceptance, the Clinical Trial Regulation, 2019, allows for phase two findings to be considered. The DCGI is now directed by the SEC in the decision-making process for restrictive use in emergency situations. We have 2 vaccines now,” said Bhargava.
Union Health Secretary Rajesh Bhushan stated:
When, on Tuesday, the Union Ministry of Health said it was prepared to carry out the Covid-19 vaccine around 10 days, however, a final decision on the date of launch has yet to be made.
“The Ministry of Health is prepared to launch the Covid-19 vaccine within 10 days of the date of the emergency use authorization, based on the feedback from the dry run of the vaccination project,” Union Health Secretary Rajesh Bhushan added.
He even said that healthcare, as well as frontline staff, do not need to register for the vaccination drive since their database was submitted in bulk to the Cowin vaccine distribution management system.
