Bharat Biotech officials to meet WHO assessors next week

The World Health Organization (WHO) will hold a ‘pre-submission’ meeting with Hyderabad based Bharat Biotech regarding the approval of its Covid-19 vaccine Covaxin on June 23.

In May, Bharat Biotech said its Emergency Use Listing (EUL) application had been submitted to WHO, Geneva, and regulatory approvals are expected between July and September.

A pre-submission meeting provides an opportunity to the company for advice and guidance before submission of the final dossier, as well as an opportunity for them to meet WHO assessors who will be involved in assessing their product.


The WHO Emergency Use Listing/Pre qualification evaluation process guidance document dated May 18 posted on the WHO website said Bharat Biotech had submitted its Expression of Interest on April 19 and that more information is required.

“The final dossier and the results of Phase III will be submitted after next week’s meeting,” a person aware of the development told ET.

Submission of Phase III data along with data on manufacturing quality is mandatory for Emergency Use Listing (EUL). The EUL pathway involves a rigorous assessment of clinical trial data as well as additional data on safety, efficacy, quality, and a risk management plan.

Bharat Biotech has released an interim analysis of its phase 3 data, but it has not yet published full results from phase 3 study in an internationally recognised peer review journal.

Bharat Biotech had earlier said it will make Covaxin's Phase-3 trial data public during July, following which the company will be applying for full licensure of the Covid-19 vaccine in India. It also said it was conducting Phase-4 trials to check the “real-world effectiveness” of the vaccines and to meet scientifically approved standards for safety and efficacy.

An emergency approval from the WHO will allow the company to export its vaccines, and enable easy international travel of Indian citizens who have been administered Covaxin.

The EU and some countries like Saudi Arabia have made it mandatory for travelers to take approved vaccines (those cleared by WHO or the US, UK, and EU regulators) before they can step foot on their shores.

At present, several countries have imposed restrictions on international travel from India but this can become a thorny issue for those who have taken the Covaxin jab once these restrictions are lifted.