Does UKs Health & Safety Executive know that AstraZeneca's Vaxzevria is not being sold, but the supply chain is still active?

Control of Substances Hazardous to Health (COSHH) Regulations 2002 (as amended) apply

Yesterday, I posted this, with a promise of more to come

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

This is the next installment.

The document below was posted on the Government website:

SUMMARY OF PRODUCT CHARACTERISTICS: 1 NAME OF THE MEDICINAL PRODUCT - Vaxzevria, suspension for injection - COVID 19 Vaccine (ChAdOx1 S [recombinant])

If you worked in the NHS during COVID, or even if you have joined since, this is vitally important information for you. In summary, while AstraZeneca has stopped selling Vaxzevria, there is no assurance that potentially hazardous materials and products in its extensive supply chain are still out there.

The document states that “This product contains genetically modified organisms (GMOs).”

This is how the document begins (have you seen it previously?)

1 NAME OF THE MEDICINAL PRODUCT

Vaxzevria, suspension for injection. COVID 19 Vaccine (ChAdOx1 S [recombinant])

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S * recombinant), not less than 2.5 × 10 8 infectious units (Inf.U)

*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.

This product contains genetically modified organisms (GMOs).

Excipient with known effect

Each dose (0.5 ml) contains approximately 2 mg of ethanol.

For the full list of excipients, see section 6.1.

6.1 List of excipients

L-Histidine

L-Histidine hydrochloride monohydrate

Magnesium chloride hexahydrate

Polysorbate 80 (E 433)

Ethanol

Sucrose

Sodium chloride

Disodium edetate dihydrate

Water for injections

This is the whole of Section 6:

6 PHARMACEUTICAL PARTICULARS

This is the final paragraph in section 6, but I’ve put it at the top to emphasise how ridiculous this all is:

Disposal

Vaxzevria contains genetically modified organisms (GMOs). Any unused vaccine or waste material should be disposed of in accordance with local requirements. Spills should be disinfected using agents with activity against adenovirus.

[Note from Hedley: Now, where can I find an agent with activity against adenovirus? That’s lucky, I just happened to have found one in my pocket!]

6.2 Incompatibilities

This vaccine must not be mixed with other medicinal products or diluted.

6.3 Shelf life

Unopened multidose vial, 9 months.

The following information is intended to guide healthcare professionals only in case of an unforeseen temporary temperature excursion. It is not a recommended storage or shipping condition. The shelf-life of unopened vials includes the following unforeseen excursions from refrigerated storage (2°C – 8°C) for a single period of:

• 12 hours up to 30°C

• 72 hours down to -3°C

Unopened vials must always be returned to refrigerated storage (2ºC to 8ºC) following an unforeseen temperature excursion.

The occurrence of an unforeseen temperature excursion for unopened vials does not impact how the vials should be stored after first opening (first vial puncture).

After first use:

Use as soon as practically possible and within 6 hours. The vaccine may be stored between 2°C and 25°C during the in-use period.

6.4 Special precautions for storage

Unopened multidose vial

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep vials in outer carton to protect from light.

After first use

For storage conditions after first use of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Multidose vial

10-dose vial 5 ml of suspension in a 10-dose vial (clear type I glass) with a halobutyl rubber stopper and an aluminium overseal with a plastic flip-off cap. Pack sizes of 10 multidose vials.

8-dose vial 4 ml of suspension in an 8-dose vial (clear type I glass) with a halobutyl rubber stopper and an aluminium overseal with a plastic flip-off cap. Pack sizes of 10 multidose vials.

[Note from Hedley: 10 or 8 doses in a vial - what is the chance of someone drawing a single dose for patient administration will be accurate? Answer - zilch].

6.6 Special precautions for disposal

Handling instructions and administration

This vaccine should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose. The vaccine does not contain any preservative.

[Note from Hedley: aseptic techniques (sterile processing) are way outside the experience of healthcare professionals - another accident waiting to happen]

Do not use this vaccine after the expiry date which is stated on the label after EXP. Unopened multidose vial should be stored in a refrigerator (2°C – 8°C).

[Note from Hedley: The temperature range of the fridge should be validated periodically, otherwise the product could degrade]

Do not freeze. Keep the vials in outer carton in order to protect from light. Vaxzevria is a colourless to slightly brown, clear to slightly opaque suspension. The vaccine should be inspected visually prior to administration and discarded if particulate matter or differences in the described appearance are observed. Do not shake the vial. Do not dilute the suspension.

[Note from Hedley: particulate matter in a vial is a gross non-compliance and it should be investigated immediately, accompanied by corrective and preventative action (CAPA).

The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.

The vaccination course consists of two separate doses of 0.5 ml each. The second dose should be administered between 4 and 12 weeks after the first dose. Individuals who have received the first dose of Vaxzevria should receive the second dose of the same vaccine to complete the vaccination course.

Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection to be administered intramuscularly, preferably in the deltoid muscle of the upper arm. Use a separate sterile needle and syringe for each individual. Each vial contains at least the number of doses stated. It is normal for liquid to remain in the vial after withdrawing the final dose. When low dead volume syringes and/or needles are used, the amount remaining in the vial may be sufficient for an additional dose. Care should be taken to ensure a full 0.5 ml dose is administered. Where a full 0.5 ml dose cannot be extracted, the remaining volume should be discarded. Do not pool excess vaccine from multiple vials.

[Note from Hedley: This is the last note, as all this is clearly concerning to any sensible person].

After first dose withdrawal, use the vial as soon as practically possible and within 6 hours (stored at 2°C to 25°C). Discard any unused vaccine.

To facilitate the traceability of the vaccine, the name and the batch number of the administered product should be clearly recorded for each recipient.

Where is UKs Health & Safety Executive?

Control of substances hazardous to health (COSHH) is a legally binding set of regulations under UKs Health and Safety Executive:

This is what they say:

“What you must do

Control of Substances Hazardous to Health (COSHH) Regulations 2002 (as amended) requires employers to:

• assess the risks that arise from the use of hazardous substances. This will include any arrangements to deal with accidents, incidents or emergencies, such as those resulting from serious spillages. The assessment must also include the health and safety risks arising from storage, handling or disposal of any of the substances

• prevent, or if this is not reasonably practicable, control exposure to such substances

• provide staff with information, instruction and training about the risks, steps and precautions the employer has taken to control these risks, eg provision of appropriate rubber gloves or appropriate eye protection

What you should know

Substances can take many forms and include (relevant categories in bold):

• chemicals

• products containing chemicals

• fumes

• dusts

• vapours

• mists

• nanotechnology

• gases and asphyxiating gases

• biological agents (germs). If the packaging has any of the hazard symbols, it is classed as a hazardous substance

• germs that cause diseases such as leptospirosis or legionnaires disease and germs used in laboratories”

I’d be interested to hear what you think of this? Remember also, the AZ injections were sent to many countries other than the UK - if you live in one of them, it could be important to you too.

More to come tomorrow, my birthday…