Bharat Biotech and the World Health Organization held a 'pre-submission' meeting on Wednesday for international emergency use listing (EUL) of Covaxin, its COVID-19 vaccine. The meeting was to give the company a chance to receive guidance from WHO authorities before the final submission.
No details have emerged about how the meeting went.
Last month Bharat Biotech said it had already submitted 90 per cent of the required paperwork. The Hyderabad-based manufacturer also said it was confident of getting the nod "given its experience of getting its other vaccines pre-qualified by WHO".
The vaccine is 77.8 per cent effective in protecting against COVID-19, according to data studied and recommended on Tuesday by the national drug regulator's Subject Expert Committee.
What Is An EUL?
WHO's emergency use listing, or EUL, is a risk-based procedure for assessing and listing new, or unlicensed, products that can be used during public health emergencies.
As of now only seven vaccines have been given EULs, including the AstraZeneca-Oxford University shot produced and sold in India as Covishield. Also on the list are the Pfizer and Moderna shots that the government has said it is working to bring to India.
What Data Does Bharat Biotech Need To Submit?
Grant of an EUL involves rigorous assessment of clinical trial data - as well as data on safety, efficacy and quality - and a risk management plan.
The WHO's website says submission for a vaccine EUL needs to follow a specific format that must include information on manufacturing quality data, and non-clinical data and clinical data.
It must also include a plan to monitor quality, safety and efficacy in the field and an undertaking to submit any new data to WHO as soon as it is available.
What Is The Evaluation Procedure?
To grant an EUL the WHO will determine if Covaxin demonstrates a "reasonable likelihood (of) quality, safety and effectiveness... and (if) the benefits outweigh the foreseeable risks and uncertainties in the context of a PHEIC (public health emergency of international concern).
According to the WHO website, criteria for grant of EUL for vaccines includes the following criteria:
- The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic
- Existing products have been unable to eradicate the disease or prevent outbreaks
- Product manufacturing is compliant with current Good Manufacturing Practices (GMP).
Importantly, according to a WHO document on 'Consideration For Evaluation Of COVID-19 Vaccines' released in November last year, "...primary efficacy endpoint estimate should be at least 50 per cent".
This means any vaccine looking to get an EUL from WHO must be at least 50 per cent effective.
Why Is The EUL Crucial?
An EUL will allow Bharat Biotech to export the vaccine and easier international travel for Indians vaccinated with Covaxin, which is so far unrecognised as a COVID-19 vaccine by some nations.
Countries that do not, as yet, have Covaxin on a list of approved vaccines include the US, Canada, Australia and the EU - all popular travel destinations for Indians, whether for work, leisure or study.
This means Indians who have received Covaxin - and there are already around 3.54 crore - may not be able to freely travel to these countries until their governments approve Bharat Biotech's drug.
Indians who have been vaccinated with Covaxin - and this includes a large number of students - will likely have to carry negative RT-PCR tests and follow quarantine rules at their destination.
The EUL is also critical from a global perspective.
As the virus that causes COVID-19 continues to mutate (and potentially acquire mutations to evade vaccines) it is necessary to ensure a significant percentage of the world's population is vaccinated.
Given the imbalance in vaccine supply across the world - some countries are struggling to provide enough doses for their people - having one more vaccine to produce and distribute is good news.