Could a Proportion of the Adverse Reactions to the COVID Injections be Caused by Breakneck Speed in the Supply Chain?

This is the case in support

Could a Proportion of the Adverse Reactions to the COVID Injections be Caused by Breakneck Speed in the Supply Chain?

What is a supply chain and why is it important for the safety of a medicine?

For those not familiar with supply chains, they bring us the food we eat, the cars we drive and the mobile phones we use to communicate. In fact, every product we consume must come to us via a supply chain. It is the series of stages a product must go through to be converted from raw materials into a finished product. This applies to medicines as it does to any product we consume.

The added complication with medicines is that they go inside your body, but unlike food, they start off as an unknown substance. No-one knows what the medicine will do to you, or what your body will do to the medicine as it is broken down when inside you. It may come as a surprise to some, but the body can convert an apparently safe medicine into a toxic one if it collects in some vital organ(s).

What normally happens in a medicine supply chain to ensure safety?

A company developing a new medicine must first construct a supply chain to produce a known quantity of the medicine’s active ingredient, typically 10 kilograms or litres.

Nowadays, Big Pharma companies use contractors to develop and produce medicines, so it can take months, even a year or more, to get all the agreements in place. Once that is done and the supply chain is operational, the medicine under test is sent off to study safety in animal models. The average timescale to get all this done is three years.

If the medicine is proven safe enough to test in humans, then the company can apply for a licence to study that medicine in humans. If the clinical trial application is successful, then studies can be run, initially in human volunteers.

From this stage onwards, the supply chain must be closely regulated to ensure that the medicine will not harm the volunteers in any way. In the UK this is the responsibility of the MHRA. There are three main responsibilities in their remit:

1.    Issue licences that allow companies to place medicines on the market.

2.    Inspect and licence key manufacturers and distributors in the medicines supply chain.

3.    Monitor the safety of medicines

Evaluating a licence application to market a medicine is based on a document that has been mandated across the world for decades. It is known as the electronic Common Technical Document (eCTD). The company applying for a licence must use the eCTD to submit data aimed at proving that the supply chain will consistently produce safe and acceptably effective medicines. This is known as chemistry, manufacturing, and controls information (CMC). This is the pharmaceutical industry’s name for all the details of the supply chain from beginning to end.

The second responsibility is to physically inspect the companies producing and distributing the medicine. A site inspection normally takes 3 or 4 days, carried out by at least two experienced inspectors. Once the inspection is complete, a report must be written recording findings, highlighting any observations of critical of major deviations. It is not unusual for companies to have to remediate issues before a licence can be awarded, which can take months, even years.

The third responsibility, monitoring the safety of medicines, is the Yellow Card system, which may be familiar to some readers. However, the primary responsibility for the safety of medicines lay with the company holding the product licence, under its obligations to maintain a pharmacovigilance process.

What changed with Covid?

For the COVID injections, MHRA introduced a shortcut version of the above established authorisation process for new medicines, termed a temporary Authorisation. Along with that, conditions of authorisation were issued by MHRA to substitute for the normal process. These were woefully inadequate in relation to safety of the supply chain. There was no mention of the supply chain companies that physically developed and produced the COVID injections.

In the case of AstraZeneca (AZ), supply chain activities were outsourced to the companies in the press releases below, Oxford BioMedica, headquartered in Cowley, Oxford, and a Wockhardt facility located in Wrexham: 

Oxford Biomedica receives MHRA approval for the first two manufacturing suites in Oxbox

Wockhardt announces COVID-19 vaccine partnership with UK Government

To date, neither of these companies’ production facilities have been physically inspected by MHRA. Distance inspections (aka virtual) may have been carried out, but to coin a phrase, they are as useful as a chocolate teapot. Only when the production facilities for all the COVID injections have been visited and inspected will we know for definite if there are quality problems in the supply chain.

What risks and harms did this create?

The risks lie in defective and/or contaminated materials and products being created at any point or points in the supply chain. The injections are known as biologic products, which means they are produced using living organisms. They are extremely unpredictable, and every manufacturer produces a clinically different product, which is a cause for concern if there is chopping and changing of injections. The biggest challenge of all with these products is the cold chain and the associated activities such as freezing and thawing materials that can change molecular form and become toxic.

The potential for harm by the pharmaceutical supply chain is incalculable and there is compelling evidence of that. During 2007/8, a blood thinning agent, heparin, become toxic when the product license holder (Baxter) procured a substance that had been illegally substituted for the genuine material (100x cheaper).

The report: After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, authored by PEW Health Group, explained the horrible details, stating: the FDA examined a subset of 574 adverse events, including 68 deaths, submitted between January 1, 2008, and March 31, 2008.

Readers may not know, but the vast majority of pharmaceutical materials have been sourced offshore (low-cost countries, mainly China) since the early 1990s. This makes proper oversight of the supply chain impossible in many cases.

What needs to happen now?

In the light of the above, and the recently exposed infected blood products scandal that caused such tragic outcomes, there is not a moment to lose. The first step is to accept that this is a dangerous problem that calls for immediate action.

As a minimum, all products that have been authorised under the conditional authorisation process must have their licences revoked and sales should cease immediately.

The next step is a product recall by MHRAs Defective Medicines Report Centre (DMRC), according to its procedure titled: A Guide to Defective Medicinal Products.

This is an excellent document as it covers all the stakeholders involved—Patients, Healthcare Professionals, Manufacturers and Distributors—and provides guidelines for reporting, investigating, and recalling suspected Defective Medicinal Products.

Note the operative word suspected, so there is no presupposition of guilt at this stage.

Next steps will follow from the investigation.

Hedley Rees is recognised globally as an expert in biopharmaceutical supply chain management and author. He has over 40-years’ experience in big pharma, biotech, and consultancy, founding PharmaFlow in 2005. His Substack, Inside Pharma, has been publishing evidence of COVID supply chain malfeasance since January 2022.