The World Health Organisation (WHO), which is reviewing Indian manufacturer Bharat Biotech's COVID-19 vaccine Covaxin for Emergency Use Listing, is likely to meet today. The world body may even come up with a decision today as top officials had said last week that only a final piece of information was required from the pharma company.
Why is the WHO's nod so important?
Without the EUA, Covaxin will not be considered an accepted vaccine by most countries around the world, making it difficult for Indians who have taken the dose to travel internationally.
The WHO has so far approved Covid vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China's Sinopharm and Oxford-AstraZeneca for emergency use.
As per Bharat Biotech, Phase III clinical trials of Covaxin had demonstrated an efficacy rate of 77.8 percent. The vaccine accounts for roughly 11 percent of the doses administered in the country.
Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V.
When did Covaxin apply for global approval?
Bharat Biotech, the Hyderabad-based pharmaceutical company which developed Covaxin, has now been waiting for months for the agency to provide a formal nod to its Covid-19 vaccine. It had submitted the Expression of Interest (EOI) for the emergency use approval as far back as in April, but WHO has said it needs more data from the company before giving the go-ahead.
The WHO said it began rolling data of the vaccine on 6 July. Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.
Why is it taking so long?
WHO has said the timeframe for its EUL procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for the global health body to evaluate the vaccine's quality, safety, efficacy and suitability for low- and middle-income countries.
When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation on whether to grant Emergency Use Listing to the vaccine, it has said.
Clarifying the reasons for the slightly longer authorisation process, a WHO official had said that the organisation's go-ahead to a vaccine candidate is like a global endorsement. So, it is very important that WHO, when it makes a recommendation like that, is absolutely sure that it has examined every shred of evidence available before telling the world that they deem the vaccine safe for use.
Commenting on the delay, a top official of the organistaion had told PTI, "It's a hugely important task. It's extremely involved and measured, and the outputs of this process have been of very high quality right...through this pandemic. And if it takes another week or two, that's what we'll have to take to ensure that the dossier is complete to ensure that the committee has a chance to look at that and then WHO can make the right determination and give the right advice to the world."
What's the process of approval?
WHO Health Emergencies Programme Executive Director Dr Mike Ryan explained that the vaccine manufacturers, first of all, have to request and respond and say that they want their vaccines to be put for EUL and then provide documentation on the whole process -- the efficacy studies and the manufacturing process.
Sometimes that requires visits to look at and examine the manufacturing practices and all of that has to come together into a dossier that's presented within this advisory group mechanism, and then it's from there that WHO can make a recommendation," Ryan said.
He emphasised that the entire process, even if people cannot see it day to day is very measured" because we're having to say to the world we've looked at this carefully, we've looked at every piece of data, we've looked at the whole production cycle and we can say with our hands on our hearts, having looked at all that data, here is a safe, effective, and well-produced product that you as our member state or you as a citizen of the world can take with confidence'.
That's very, very important and that sometimes takes longer and it is frustrating. And it is particularly frustrating if you've had a certain vaccine that is not recognised by another country and you can't travel. That becomes an issue, Ryan said.
He said the work done by the advisory group and its members has been of the highest quality, and it takes time to do that".