AstraZeneca abandons Vaxzevria for commercial reasons—sorry, it's not that simple—there's a supply chain to consider

Materials and components will still be located all over the globe; some hazardous!

AstraZeneca abandons Vaxzevria for commercial reasons

Below is an announcement from the European Commission on AstraZeneca’s withdrawal of its SARS-CoV-2 sterile injectable ‘Vaxzevria’:

Vaxzevria1 (COVID 19 Vaccine (ChAdOx1 S [recombinant])): Withdrawal of the marketing authorisation in the European Union

It begins: “On 27 March 2024, the European Commission withdrew the marketing authorisation for Vaxzevria (COVID 19 Vaccine (ChAdOx1 S [recombinant])) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.”

Sorry, but it’s not that simple

Unfortunately, it is not that simple. A fully functioning supply chain was constructed for the development, manufacture and distribution of Vaxzevria sterile injectables.

MHRAs own Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The MHRA Orange Guide) 2022, Edited by MHRA state that the Marketing Authorisation Holder (MAH - AstraZeneca), is wholly responsible for the safety, quality and efficacy of its licenced products, as detailed on page 438 of the Orange Guide below.

This is the key extract: “It should be noted that, as indicated in Annex 16 of the GMP Guide, the ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the MAH.”

Supply Chain Production Stages

These are the production stages in the supply chain for a biologic product (this applies to all the SARS-CoV-2 injectables) - the quality element:

Starting materials are the animal cell-lines produced to make the drug substance (DS), known in the industry as upstream processing. DS is the bulk liquid containing the spike protein. Drug Product is the bulk DS filled into vials and capped, known as upstream processing.

What do we know about the Vaxzevria supply chain?

We don’t know an awful lot about the entire supply chain, but we do know a key contract manufacturer involved. Below is the DS supplier visited by Boris Johnson in January 2021:

This is the crucial point

Oxford BioMedica will be contracting to AstraZeneca on a fee-for-service basis, underpinned by a supply agreement and a technical agreement (AZ must supply the technical licence details to all it’s contractors).

This principle applies right across the end-to-end (E2E) supply chain (from raw materials to product in vaccination centres being administered to people). It is for AstraZeneca to ensure every scrap of material, component and product in the E2E supply chain is properly traced, identified, assessed for disposition, and disposed of in a safe manner.

The scale of the task at hand

Subscribers may now be wondering about the scale of the task AstraZeneca (AZ) is faced with. Using OXB above as a working example, we can begin to get an idea.

AZ will need to get all the records that trace every supplier batch of raw and starting material received by OXB during the life of the supply contract. Not only that, but this must go right upstream to original sources.

Then they will need to know what batches of raw and starting material were used in manufacture of the DS to be shipped to the next stage. Finally, shipments out of the plant will need to be tracked to shipment destinations from the plant, by batch number.

That is just one small part of making sure there are no loose ends when a company exits its marketing authorisation responsibilities.

There is more to come

There is more to come on this topic, only I want to take it in small steps. The thing to bear in mind is that this is all common sense in any other industry sector—we just take it for granted that a company selling physical products will have the overriding handle on its supply chain.