The Hyderabad-based drug manufacturer Bharat Biotech has shared the data of the phase 3 trials of the COVID19 vaccine Covaxin with the Drug Controller General of India (DCGI).
Covaxin vaccine was granted emergency use authorisation in India in January although the data of phase 3 trials were not available.
Also, Bharat Biotech is expected to hold a ‘pre-submission’ meeting today, June 23, with the World Health Organization for international emergency use listing (EUL) of its vaccine.
An EUL approval from the WHO will enable Bharat Biotech to supply its vaccines to more countries and ensure easier international travel for Indian citizens vaccinated with Covaxin, which is not yet recognised as an approved COVID19 vaccine by foreign governments including the European Union and the United States.
Why is Covaxin not approved by WHO?
The process for approval of a vaccine by WHO consists of four steps: an acceptance of the manufacturer’s expression of interest (EOI), a pre-submission meeting between WHO and the manufacturer, acceptance of the dossier for review by WHO, decision on status of assessment, and the final decision on approval.
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In case of Bharat Biotech’s Covaxin, the first step itself i.e. it’s EOI has not been accepted yet and in its status report, WHO remarks that ‘more information is required’.
So far, only Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved the Covaxin.
The Hyderabad-based biotech company had submitted its EOI on April 19. The second step, the pre-submission meeting is scheduled for this month (June 2021).
Meanwhile, Pune-based Serum Institute of India (SII), which manufactures Astrazeneca’s Covishield vaccine, was approved by WHO on February 15 after clearing the same four steps.
