On 3 November, Covaxin has been granted Emergancy USe Listing by the WHO.
What this means is that Bharat Biotech's COVID-19 Vaccine, Covaxin is now officially recognised by the World Health Organisation as being safe and efficous in protecting against COVID-19.
The announcement by the WHO comes after a long wait, and several rounds of review of the information submitted by the company to the WHO.
Bharat Biotech's Covaxin is India's first homegrown vaccine to make it to the list of COVID vaccines recognised by the WHO. Other COVID-19 vaccines on the list include Covishield, Pfizer and Moderna among others.
It must be noted that an EUL from the WHO is different from an EUA granted by individual countries.
Why is the WHO Authorisation Important?
While the latter applies only within the said country, an EUL from WHO means that the particular vaccine is being recognised by the WHO and anyone who has received the complete dosage of the vaccine will be considered fully vaccinated.
The decision is made after a rigorous review of the vaccine's quality based on the data submitted to the WHO by the company.
An EUL will allow countries to expedite their own regulatory approval to import and administer Covaxin, like other WHO approved COVID-19 vaccines.
This will also be a welcome respite for Indians travelling abroad who have taken Covaxin, as WHO's approval will facilitate the recognition of the vaccine by more and more countries.
This also means that Covaxin can now be supplied to poorer countries as part of the COVAX initiative.
But, for Covaxin, the road to the WHO list has been one fraught with bumps and blocks. Let's trace the timeline of Covaxin's journey, from announcement to WHO approval.
Covaxin's Journey to WHO Approval
Covaxin's journey begins where all COVID-19 vaccines' journeys begin—the start of the COVID pandemic in December 2019.
But it wasn't until May 2020 that it was announced that an indigenous COVID vaccine was being developed in India.
On 9 May Indian Council of Medical Research (ICMR) made an official announcement that they were partnering with Hyderabad based Bharat Biotech to develop an indigenous COVID-19 vaccine.
They also said that they will attempt to fast track its approval in the light of the raging pandemic.
On 30 June, India's Drugs regulatory body, DGCI (Drugs Controller General of India) gave Covaxin the go ahead for human trials.
On 15 July, phase 1 clinical trials of the vaccine began. The announcement was made on 17 July.
Bharat Biotech, at that point, had also announced that they aimed to produce 300 million doses of the vaccine if the trials were successful.
On 11 September, Bharat Biotech announced that results of animal trials have found that Covaxin is safe and effective.
On 16 November, the company announced that they were beginning phase 3 trials for the vaccine.
In the meantime, a few different announcements were made regarding the expected date of the vaccine's launch.
On 22 November, the company made the announcement that Covaxin has an efficacy of at least 60 percent based on data from earlier trials. However, the company did not release any of this data.
Lack of transparency when it comes to the clinic trials, and publicly available data, has in fact, haunted Covaxin's credibility all through the way.
On 7 December Bharat Biotech officially applied for Emergency Use Authorisation for Covaxin. This announcement came close on the heels of India's other COVID vaccine contender Covishield applying for an EUA.
On 9 December, However, the DGCI asked Bharat biotech to submit more data for Covaxin before it could be granted an EUA.
On 2 January 2021, Covaxin received EUA from the DGCI for restricted use "in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains”.
At this point, the company was still in the process of recruiting volunteers for its phase 3 clinical trials.
At the same time, the actual efficacy of the vaccine was still a big question mark.
On 5 January, it was announced that the first batch of Covaxin had been dispatched to the Central Research Institute in Kasauli. Although, exactly how many units were sent was not disclosed.
On 3 March, it was then announced that interim results of the phase 3 clinical trials for Covaxin showed an 81% efficacy in preventing COVID.
On 8 March, results of the vaccine's phase 2 trials were finally made public. The study results were published in the journal Lancet, which declared it to be "safe, immunogenic with no serious side effects".
Quickly, following this, on 11 March, the Drugs Controller General of India (DGCI), announced that Bharat Biotech’s Covaxin was no longer in 'clinical trial mode', although it remains approved under an EUA.
On 21 April, a second interim result of the phase 3 trials were announced which showed a drop in the efficacy of the vaccine from the initial 81 percent to a 78 percent.
On 3 July, the final safety and efficacy analysis data for the phase 3 clinical trials of the vaccine was announced by Bharat Biotech in a preprint paper.
The data found Covaxin to have an overall efficacy of 77.8 percent.
The peer reviewed findings of this study are yet to be made public.
Covaxin's recognition by the WHO (World Health Authority) has been in a limbo since.
According to the WHO, Bharat Biotech has been submitting data from their clinical trials to the WHO on a rolling basis for a EUL, the last of which was submitted on 27 September.
On 5 October, WHO announced via a tweet that they were reviewing all the data and evidence provided to them by Bharat Biotech and that based on these, they were going to take a final call in the coming week.
On 18 October, WHO asked Bharat Biotech to submit more data, adding that the process would need to take it's due time and that they couldn't 'cut corners' when it comes to making this decision.
On 26 October, in response to the anstiness at the delay in announcing their decision, WHO's advisory committee asked for more 'clarification' and time to deliberate over Bharat Biotech's application to include Covaxin a spot on it's EUL, adding that it isn't a decision that can be made hastily.
This brings us to 3 November when WHO officially announced that Covaxin has finally been added to it's list of recognised and recommended vaccines.
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