World Health Organisation version of the Pfizer package insert for Cominarty JN1

Important work done to access this here:

(100) I found the covid 19 vax WHO Package leaflet: Information for the user Comirnaty 30 micrograms/dose concentrate for dispersion for injection Adults and adolescents from 12 years COVID-19 mRNA Vaccine

I can’t access the leaflet if I put in United Kingdom, so I put in Denmark and translated it to English (I did not try Ireland):

Pfizer-BioNTech COVID-19 Vaccine | cvdvaccine.com

To get this in Danish:

twelve_years_and_older_denmark

And here’s a translation of the ingredients:

The information below is for healthcare professionals only:

Administer Comirnaty JN.1 intramuscularly as a single dose of 0.3 mL regardless of previous COVID-19 vaccination status.

If the person has previously been vaccinated with a COVID-19 vaccine, they should not receive a dose of Comirnaty JN.1 until at least 3 months after the last dose.

If the person is severely immunocompromised, they may be given additional doses.

Traceability

To improve the traceability of biologics, the name and batch number of the administered product must be clearly recorded.

Handling instructions prior to use Comirnaty JN.1 should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.

Instructions for pre-filled syringes

Pre-filled glass syringes

• Before use, the thawed pre-filled syringes may be stored for up to 12 hours at temperatures ranging from 8 °C to 30 °C. Thawed pre-filled syringes can be handled in normal room light conditions.

• Remove the needle cap by slowly turning the cap counterclockwise. Do not shake. Attach a cannula suitable for intramuscular injection and administer the entire volume.

Disposal

Unused product or waste material should be disposed of in accordance with local requirements. 6

5. Storage

Keep the medicine out of the reach of children.

The following information on storage, expiration date, and handling is for healthcare professionals.

Do not use this medicine after the expiry date which is stated on the carton and label after Exp. Store in a freezer at 2 °C to 8 °C. DO NOT FREEZE. Store in the original outer package in order to protect from light.

The vaccine will be received and stored at temperatures of 2 °C to 8 °C (refrigerated only). Before use, the pre-filled syringes can be stored for up to 12 hours at temperatures between 8 °C and 30 °C. Thawed pre-filled syringes can be handled in normal room light conditions.

Do not use this vaccine if you notice that it contains particles or that it is discoloured.

Ask your pharmacist how to dispose of any unused medicine. For the sake of the environment, do not throw pharmaceutical residues down the drain, toilet or rubbish bin.

4 6. Comirnaty JN.1 contains the active substance of COVID-19 mRNA vaccine (nucleoside modified): called bretovameran.

− Each pre-filled syringe contains 1 dose of 0.3 ml each, each containing 30 micrograms of bretovameran.

• The other ingredients are:

- ((4-hydroxybutyl)azandiyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) - - - - 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) cholesterol trometamol

trometamol hydrochloride

sucrose

water for injections

Appearance and contents of the pack.

The vaccine is a white to off-white dispersion (pH: 6.9-7.9) supplied in a pre-filled syringe (type 1 glass syringe) with a plunger stopper (synthetic bromobutyl rubber) and a needle cap (synthetic bromobutyl rubber) without needle.

Can’t see SV40 or any other contaminants/adulterations!

I am not sure there is anything we haven’t already seen, though I may be mistaken, what is important is that everyone receiving an injection should have been informed about these (and others I have omitted) BEFORE taking an injection – that should have been administered by a medical professional - ideally one that knows the medical history of the patient.

I can’t help but wonder how many developing countries – and even developed countries – properly disposed of expired or unused dose. Do all countries and States have adequate secure disposal facilities, or do they throw these down toilets, thus polluting any “sewage samples” taken by health regulators and authorities.

And here is some other stuff (I have not d of bretovameran before:

“Package leaflet: Information for the user Comirnaty JN.1 30 micrograms/dose of solution for injection, dispersion Adults and adolescents aged 12 years and older COVID-19 mRNA vaccine bretovameran. This medicinal product is subject to additional monitoring. This allows new information on safety to be obtained quickly. You can help by reporting all the side-effects you get.

See the end of section 4 on how to report side effects.

Read all of this leaflet carefully before you start receiving this vaccine as it contains important information for you.

• Save the package leaflet. You may need to read it again.

• Ask your doctor, pharmacist or nurse if there is anything else you want to know.

• Tell your doctor, pharmacist or nurse if you get any side effects, including those not listed in this leaflet. See point 4. See the latest package leaflet on www.indlaegsseddel.dk

Summary of the package leaflet 1. 2. 3. 4. 5. 6.

1. What you need to know before you are given Comirnaty JN.1

2. How Comirnaty JN.1 is given side effects Storage Contents of pack and other information

3. Forms of action and use

4. Comirnaty JN.1 is a vaccine used to prevent COVID-19 caused by SARS-CoV-2.

5. Comirnaty JN.1 30 micrograms/dose of dispersion for injection is given to adults and adolescents aged 12 years and older.

6. The vaccine causes the immune system (the body's natural defences) to produce antibodies and blood cells that counteract the virus to provide protection against COVID-19.

7. Since Comirnaty JN.1 does not contain virus to form immunity, the vaccine cannot give you COVID-19.

8. This vaccine should be used in accordance with official guidelines.

2. What you need to know before you are given Comirnaty JN.1 Comirnaty JN.1 must not be given • If you are allergic to the active substance or any of the other ingredients of Comirnaty (listed in section 6)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given the vaccine:

• you have ever had a severe allergic reaction or difficulty breathing after any other vaccine injections, or after you received this vaccine earlier.

• you are nervous about the vaccination process or have ever fainted after an injection of 1 needle.

• you have a serious illness or infection with a high fever. However, you can get your vaccination if you have a slight fever or …”

Copy and paste truncated at this point.

Presumably, in the US and UK, no packet insert is required while under EUA that has recently been extended for five years to end 2029?

Onwards!!!

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