No, PM Modi – WHO Vaccine Approval Process Doesn’t Need Reform

  • Vaccines are developed from scratch and are administered to healthy people, so the WHO’s approval process for COVID-19 vaccines is more stringent and time-consuming.
  • Prime Minister Narendra Modi pitched on May 12 to reform the WHO’s vaccine approval procedure “to keep supply chains stable and predictable”.
  • However, companies that manufacture vaccines factor in the time taken for regulatory bodies and/or the WHO to approve their products while planning their supply chains.
  • Prime Minister Modi also hasn’t produced evidence to question the judgment of the WHO’s technical advisory groups.

New Delhi: Prime Minister Narendra Modi made a headline-grabbing pitch to reform the WHO when he addressed the second ‘Global COVID Virtual Summit’ on May 12. In his brief speech, Modi said, “We also call for streamlining the WHO’s approval process for vaccines and therapeutics to keep supply chains stable and predictable.”

Many countries have expressed a desire to ‘reform’ the WHO in different ways – but it was rare to see a prime minister calling for changes in the WHO’s approval process. The latter is a high-level and rigorous scientific exercise.

Prime Minister Modi’s statement has two implications:

  1. The approval process has to be improved or streamlined in some way, and
  2. The current process is being perceived as an obstacle to keeping the supply chains of vaccines and therapeutics “stable and predictable”.

Both of them are problematic because of what we already know about the WHO’s approval.

The WHO website has a detailed document addressed to vaccine manufacturers, policymakers and other stakeholders that describes its approval process.

Vaccines and drugs are treated differently. All drugs that the WHO has approved against COVID-19 are repurposed: they were and are being used to treat a different disease and which have been found to be efficacious to varying degrees against COVID-19 as well.

On the other hand, vaccines are developed from scratch and are administered to healthy people, not sick people. So the approval process for COVID-19 vaccines has been more stringent and, as a result, more time-consuming.

“The WHO functions through technical advisory groups for approvals,” virologist Shahid Jameel explained. “These groups are made of individuals of multiple expertise and those individuals come from different regions.”

He added that if we are to question their judgment, we need “solid evidence”. And “unless you produce that, you have to trust it”.

In addition, Neeta Sanghi, an expert in pharmaceutical supply chains, said all companies that manufacture vaccines and drugs factor in the time taken for regulatory bodies and/or the WHO to approve their products while planning their supply chains. “They do it right from the stage of [vaccine or drug] development,” she said.

These facts, taken together, throw the spotlight back on Prime Minister Modi’s statement implying that the WHO’s approval process is in need of streamlining.

As Sanghi said, “It is hard to conclude that [the process] is over-designed or has unnecessary steps that create an uncertainty in supply-chain management.”

Both Jameel and Sanghi also said that the WHO can’t cut corners in science just to see that there is a smooth supply chain. Ensuring the latter is not its job but that of the pharmaceutical companies, according to them.

Prime Minister Modi’s comment is also unfair because it points the finger solely at the WHO when in fact many entities are involved in quality control. Pharmaceutical firms are supposed to test every batch, followed by independent tests conducted by regulatory agencies – both according to laws specified by the governments of each country.

So “the supply chain actually gets affected when a certain batch or batches are rejected at these levels of scrutiny,” Sanghi said. “The approval process per se doesn’t lead to an impediment.”

Modi’s statement comes against the backdrop of two raging disputes between India and the WHO. The latest was over the number of COVID-19 excess deaths in India. The WHO estimated India’s actual death toll due to the epidemic to be 4.7 million but the Modi government stood by its tally of 0.5 million.

The second issue which created friction between India and the WHO was the latter suspending the supply of Covaxin, co-developed by Bharat Biotech, Hyderabad, and the Indian Council of Medical Research, to UN agencies in April 2022. The WHO cited “deficiencies in the good manufacturing process” at a Bharat Biotech facility. It is the first and only COVID-19 vaccine thus far to face this penalty.

In response to queries from The Wire Science, the WHO had said, “Problems were detected in some parts of the manufacturing process. Some changes were made after the [emergency-use license] was granted but were not submitted to the national drug regulator and WHO for evaluation and validation.”

These issues together were far from resolved when Modi made his statement about the WHO. They added to the friction leftover between the two entities when experts at the WHO took six months to grant their license to Covaxin – and after a lot of back and forth and requests for additional information.

Bharat Biotech MD Krishna Ella later blamed the delay in approval on negative coverage by the media, however.

The latest remarks by Modi assume greater importance today because of the stature of their origin: the prime minister himself – that too within a month of an exaggerated display of bonhomie between him and the WHO director-general at an event in Ahmedabad. While diplomacy could explain these contradictions, they remain inexplicable through the lens of science.