BHARAT BIOTECH LIKELY TO MEET W.H.O. FOR NOD
The WHO accepted Hyderabad-based firm’s Expression of Interest (EoI) for Covaxin on June 18
NEW DELHI: Bharat Biotech, manufacturer of India’s homegrown vaccine against Covid-19 Covaxin, may attend a pre-submission meeting with World Health Organization on Wednesday, a step that will push the vaccine producer closer to WHO emergency use listing (EUL).
As per the WHO, the vaccine manufacturer will have an opportunity to submit a summary on the overall quality of the shot.
In a major boost to the Hyderabad-based firm, the WHO on June 18 accepted its Expression of Interest (EoI) for Covaxin and scheduled a presubmission meeting for Wednesday.
Last month, Bharat Biotech said that it expects approval for its Covid vaccine from the health organisation for emergency use listing during July to September.
EUL is the procedure to streamline the process by which new of unlicensed products can be used during public health emergencies like the coronavirus pandemic.
NEW DELHI : Bharat Biotech, manufacturer of India’s homegrown vaccine against Covid-19 Covaxin, may attend a pre-submission meeting with World Health Organization on Wednesday, a step that will push the vaccine producer closer to WHO emergency use listing (EUL).
As per the WHO, the vaccine manufacturer will have an opportunity to submit a summary on the overall quality of the shot.
In a major boost to the Hyderabad-based firm, the WHO on June 18 accepted its Expression of Interest (EoI) for Covaxin and scheduled a pre-submission meeting for Wednesday.
Last month, Bharat Biotech said that it expects approval for its Covid vaccine from the health organisation for emergency use listing during July to September.
EUL is the procedure to streamline the process by which new of unlicensed products can be used during public health emergencies like the coronavirus pandemic, according to the WHO.
The pre-submission meetings do not require the manufacturer to submit a detailed report about the jab but provide an opportunity for advice and guidance before the submission of a medicines dossier. It also offers an opportunity for the applicant to meet WHO medicine assessors who will be involved in assessing their product, as per the organisation.
“The pre-submission meeting does not include a detailed review of data or full study reports. However, an essential aspect of the meeting is the submission (at least two weeks in advance of the pre-submission meeting) of a completed QOS-PD (Quality overall summary product dossiers),” WHO explained the process of the pre-scheduled meeting, reported news agency PTI.
Bharat Biotech has conveyed to the Centre, as per previous reports, that it has already submitted 90 per cent of the documents to WHO for the getting EUL for Covaxin vaccine. The company said that it expects to submit the remaining documents by June.
Meanwhile, an expert panel of the country’s central drugs authority reviewed and accepted the phase 3 trial data of Covaxin on Tuesday.
“The required data was submitted by the company, and the subject expert committee went though it today. The experts were satisfied with the results presented, and the vaccine efficacy is confirmed at 77.8%,” said an official in the government aware of the development, on condition of anonymity.
The firm had submitted the results of its phase-3 trial efficacy data of Covaxin to the Drugs Controller General of India (DCGI) over the weekend.
The efficacy rate is similar to interim trial analyses, but the company is yet to release data regarding the multiple analyses it has carried out at different points in time. The trial was carried out in 25,800 volunteers.
The vaccine was approved for emergency use in the Indian population in January, and the Hyderabad-based company had then said it would release phase III data by March. The release has since been pushed back on several occasions.