WHO PQ listing for Remdesivir

A SHORT BLOG:

Questions are beginning to emerge as to why WHO proceeded to give a prequalification listing to Remdesivir, when it was aware of the results of its Solidarity Therapeutics trial on the drug’s lack of impact on the treatment for COVID-19.

At the bi-weekly presser (on 16.10) last week, WHO’s top officials discussed briefly the independent processes of the prequalification process for Remdesivir (officially announced on the 15th) and the results of the Solidarity trial (highlighted on the 16th.)(See Soumya Swaminathan and Mariangela Simão address this question, half way into the briefing)

It is also understood that the results from the Solidarity trial were confidential until the night of publication and the prequalification process had already been completed.

We sent queries to WHO to examine this further, when a source brought this to our attention.

Manufacturers of potential COVID-19 treatments (including remdesivir and dexamethasone) were first invited to submit their products for WHO prequalification in early July 2020.

According to WHO, this was done based on the best available evidence at the time as per interim results from the Recovery trial (for dexamethasone) and the NIAID-ACTT-1 (for remdesivir). The invitation was issued with a view to speed up regulatory assessment processes and ensure increased manufacturing capacity in case the final results proved that the medicines were both safe and efficacious. This approach has been used in previous emergencies. WHO says that the issuing of the EoI for Remdesivir was done as a preparedness measure, based on the interim results from the NIAID trials, allowing for increased generic production.

A WHO spokesperson told Geneva Health Files:

WHO prequalification can occur in 2 ways: 1) a full assessment where WHO evaluates all the evidence related to the quality, safety and efficacy of the products; and (2) an abridged assessment where WHO relies on evaluations carried out by stringent regulatory authorities. In the case of remdesivir, the abridged process was adopted, based on the EMA’s conditional approval of the product.

The Solidarity trial and Prequalification are separate processes: The prequalification procedure for remdesivir started long before the Solidarity trial results were analyzed and needed to be completed, despite the trial results that emerged.

Prequalification listings can be reviewed: Prequalification listings can, and have been reviewed based on any new information that might change the basis for the listing. In this case, the PQ listing of remdesivir will be reviewed immediately following the recommendations from the WHO Guidelines Review Panel, or review of the conditional approval of the product by EMA, which was the basis for the listing.

It was also pointed out that the prequalification of remdesivir was based on the EMA’s conditional approval of the product, as part of a collaborative agreement between EMA and WHO.

It gets more curious. Politico ran a story about European Commission’s position on this.

According to Politico [COMMISSION, EMA ASSESS WHO REMDESIVIR DATA]:

Excerpts:

“…WHO shared data with Gilead at least two weeks prior to signing the contract with the Commission, although the drugmaker said it was a “heavily redacted” manuscript…”

“…The WHO verbally shared the topline results from its study with the EMA on October 9 — a day after the Commission announced its latest deal with Gilead for the drug — an EMA spokesperson told POLITICO in an email Monday evening. The data was immediately shared with its pandemic task force, which includes a Commission rep. The agency noted the data are not yet peer reviewed, but it will assess them when they are made available…”

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