Description

Date - 22nd Jun 2021

Amid concerns about the effectiveness of Bharat Biotech's COVAXIN, a vaccine manufacturer made in India has submitted phase 3 trial data to the Drugs General Controller of India (DGCI). The drug regulator's subject expert committee (SEC) is expected to meet on June 22, 2021 to discuss the results. Bharat Biotech data is not yet fully published in a recognized peer-reviewed journal.

Bharat Biotech's COVAXIN, the only COVID-19 vaccine developed in India, is among three vaccines that have been approved for administration in India to vaccinate people against infection. The other two approved vaccines are COVISHIELD and Russia's Sputnik V.

In April 2021, Bharat Biotech announced that COVAXIN showed 78% efficacy against mild, moderate and severe COVID-19 infections, according to an interim phase 3 analysis.

Bharat Biotech has published the first interim analysis of the Phase III COVAXIN results. The data showed 81% intermediate efficacy in preventing COVID-19 infection in those who had no prior infection after the second dose.

Data from a Phase 3 clinical trial also showed a 100% reduction in the likelihood of hospitalization in the event of infection.

Why was Bharat Biotech criticized?

An Indian vaccine manufacturer has been heavily criticized for delaying the release of data from Phase 3 clinical trials of the COVID vaccine. COVAXIN was approved by the DGCI for Limited Emergency Use in India in January 2021 based on data from Phase 1 and 2 clinical trials.

However, an early study recently showed that the Covishield vaccine produces more antibodies against COVID-19 infection than COVAXIN. The study also claims that after two injections of the vaccine, 98% of COVISHIELD recipients showed an antibody response, while 80% of COVAXIN recipients did.

Phase 3 COVAXIN data has also previously been questioned. Phase 3 vaccine data are critical as they establish the effectiveness of the vaccine.

Bharat Biotech's Response

The Hyderabad-based vaccine maker downplayed the study and said the preliminary study had "many flaws" and was done on a one-off basis. He also added that the study was not peer-reviewed or scientifically developed.

The preliminary meeting of Bharat Biotech with WHO

Bharat Biotech is also expected to hold a preliminary meeting with the World Health Organization (WHO) on June 23, 2021. The meeting will focus on the International Emergency Use List (EUL). It will also provide an opportunity to obtain advice from WHO authorities prior to final submission.

The EUL from the global health authority will allow Bharat Biotech to export COVAXIN, as well as facilitate international travel for Indian citizens who have been vaccinated with COVAXIN, which is not yet recognized as a valid vaccine by other governments.

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