Hyderabad: Bharat Biotech, the company manufacturing Covaxin in India, is expected to attend a “pre-submission” meeting with the World Health Organisation (WHO) today. The world health body had on June 18 accepted the Hyderabad-based company’s Expression of Interest (EoI) for Covid-19 vaccine Covaxin and scheduled a “pre-submission” meeting on June 23.Also Read - Covaxin For Children Above 2 Years Will Be Available In By September, Says AIIMS Chief Randeep Guleria

All you need to know about the meeting:

  1. The development assumes significance as the step will take the vaccine maker closer to a WHO emergency use listing (EUL).
  2. As per WHO guidelines, EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
  3. The meeting will not be a detailed review on the product but the vaccine maker will have an opportunity to submit a summary on overall quality of the jab.
  4. Bharat Biotech had said last month that it expects approval for its COVID-19 vaccine Covaxin from the World Health Organisation for emergency use listing during July-September.
  5. According to WHO, pre-submission meetings provide an opportunity for advice and guidance before submission of a medicines dossier, as well as an opportunity for the applicant to meet WHO medicine assessors who will be involved in assessing their product.
  6. Sources had earlier indicated that Bharat Biotech International Limited (BBIL) has conveyed to the Centre that it has already submitted 90 per cent of documents to WHO for obtaining EUL for Covaxin.
  7. The remaining documents are expected to be submitted by June, the city-based vaccine maker had told the Central government during a discussion last month on obtaining theWHO’s authorisation for EUL for Covaxin.
  8. Meanwhile, an expert panel of the country’s central drugs authority has reviewed and accepted the phase-3 trial data of Bharat Biotech’s Covaxin. The indigenously developed vaccine has shown 77.8 per cent efficacy in the trial conducted on 25,800 subjects.