Bharat Biotech submits COVAXIN phase 3 trial data to DGCI before WHO's meet: Reports

Ahead of the scheduled pre-submission meeting on June 23 with the WHO, Hyderabad-based pharmaceutical company Bharat Biotech has reportedly submitted Phase 3 clinical trials data of COVAXIN to the Drugs Controller General of India (DCGI) over the weekend, as reported by ANI. Recently, the WHO had accepted Bharat Biotech's Expression of Interest (EoI) for COVID-19 vaccine COVAXIN and scheduled a pre-submission meeting, a step that will take the vaccine maker closer to a WHO Emergency Use Listing (EUL). COVAXIN is among three vaccines currently being administered in India against the COVID-19 pandemic.

Though the meeting will not be a detailed review of the product, the vaccine maker will have an opportunity to submit a summary of the overall quality of the jab, according to the WHO. The information was provided on the WHO website in the Status of COVID-19 Vaccines within WHO EUL-PQ evaluation process document. 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.

Last week, Bharat Biotech had said that it will publish the phase 3 trial data in July, and following that the company will be applying for the full licensure for COVAXIN. In a press release, the Hyderabad-based vaccine manufacturer said, "It is critical to understand, and further emphasise the Phase-3 data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier COVAXIN phase 3 results full trial data will be made public during July. Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN."

The COVAXIN phase 3 trial

In March, Bharat Biotech said that its COVID-19 vaccine - COVAXIN - a Whole Virion Inactivated Corona Virus Vaccine - has shown an interim clinical efficacy of 81% in its Phase 3 trials. The phase 3 trials involved 25,800 subjects and is the largest ever trial conducted in India. COVAXIN has been granted permission for restricted use in an emergency situation by the DGCI in January 3. Union Health Minister Dr. Harsh Vardhan explained that COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) and the recent double mutation (Indian variant). The participants enrolled were between the age of 18-98 years old including 2,433 over the age of 60 and 4,500 with comorbidities. Amid heavy politicisation, Centre roped in several PSUs to produce COVAXIN and approved an advance payment of Rs 1500 crores to BBL to ramp up COVID-19 vaccine production.

(Image Credits: PTI)