What Can Possibly Explain WHO's Delay In Approving Covaxin?

Since the announcement about Covaxin data submission by Bharat Biotech for the approval from World Health Organization (WHO), reports have been emerging, predicting the date for the final decision on the Indian Covid -19 vaccine.

According to WHO’s chief scientist Soumya Swaminathan, the agency’s technical advisory group will meet on 26 October to consider granting Emergency Use Listing (EUL) to the vaccine.

Many people in India are keeping an eye on it because their travel plans are dependent on the WHO's EUL for the vaccine. Young people who have taken Covaxin and want to study abroad are hoping for approval from the UN agency, as numerous nations, notably the United States, have declared they will recognise vaccines approved by the global health body.

Despite the fact that various public health organisations have spoken out against requiring vaccination as a condition of travel, the practice continues in a number of nations, including in Europe.

Earlier this week, the WHO said on Twitter that it understands that many people are waiting for its recommendation on whether Bharat Biotech's Covid vaccine Covaxin should be added to the EUL, but it can't rush it, adding that it needs more evidence from the Hyderabad-based vaccine maker.

WHO previously stated that Bharat Biotech has been supplying data to them on a rolling basis and that fresh material was submitted on 27 September after the global health authority requested further information.

The Approval

As per Mint, an unnamed scientist who has counselled companies on how to submit applications for WHO vaccine prequalification said: “WHO has a process and it has technical reports specific to each class of vaccines and the requirement from companies. The prequalification team (in this case, for EUL) also gives clear guidance on what is expected from companies.”

“Then there are clinical data requirements. Unless companies submit these data together to the scientific advisory group of experts, they cannot decide whether to grant EUL or not," the person added.

The person also said that “if that data is insufficient, the approval doesn’t go through"— this happened with Covaxin already; after the Brazilian authority, ANVISA declined to give a green signal to Bharat Biotech’s jab, apparently due to lack of data.

However, WHO in a Twitter thread on 18 October said that it is awaiting "one additional piece of information" from Bharat Biotech before deciding whether or not to award the EUL.

In the case of Bharat Biotech, the problem is not that the company is unfamiliar with the procedure. It has previously received prequalification for various other vaccinations, such as those for typhoid and rotavirus. Those vaccines, however, were developed on a different platform than Covaxin, which is developed using Whole-Virion Inactivated Vero Cell derived platform technology.

Though Covaxin was licenced by Indian regulators in January this year when the company began phase 2 studies, WHO requires evidence from the phase 3 trial. Bharat Biotech's phase 3 data was only released in July.

However, WHO's technical committee takes anywhere from three to five months to make a EUL decision considering several factors. According to Mint, an official at an Indian drugmaker said: “Now, as we compete on a global scale, we realise how difficult global processes are."

The UN agency said in the Twitter thread that the timeframe for the EUL method is determined by how soon a firm making the vaccine can deliver the data needed for WHO to evaluate the vaccine's quality, safety, efficacy and suitability for low and middle-income nations.

A senior official at Bharat Biotech told The Indian Express on 18 October that the WHO was following the standard review process and the company was sharing all information requested.

Meanwhile, WHO's chief scientist Swaminathan said in a Tweet: “The technical advisory group will meet on 26 October to consider EUL for #Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere.”