AstraZeneca COVID-19 Vaccine Formulation information

John Minshull, Deputy Director, London Medicines Information Service, Specialist Pharmacy ServicePublished

Formulation information such as latex content, diluent, sodium content and stability, is provided for AstraZeneca COVID-19 Vaccine.

Latex content

Public Health England’s COVID-19 Vaccination Programme Information for Healthcare Professionals states that the rubber stopper of each multidose vial of AstraZeneca vaccine consists of halobutyl, and does not contain latex.

In the context of the information included in The Green Book (chapter 6), which provides advice on managing vaccine choice in patients with severe (i.e. anaphylactic) allergy to latex, the AstraZeneca vaccine can be considered not to contain latex.

However, even if the components of an injection do not contain latex, or latex is not used as a raw material during manufacturing, most manufacturers of injectable products advise they cannot guarantee minute amounts of latex are not contained in raw materials obtained from their suppliers or the product has not come into contact with latex during the manufacturing process. As this is true of all injectable medicines it is the SPS view that the risk for people with latex allergy is the same as with other injectable medicines presented in vials with a halobutyl rubber stopper.

Therefore there seems to be no reason to regard this vaccine as unsafe for patients with known latex allergy.

Patients with an allergy to latex can be directed to the Anaphylaxis Campaign website for information.

Sodium content

The MHRA Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca states that the vaccine contains less than 1 mmol sodium (23mg) per dose and is considered to be essentially ‘sodium-free’.

Stability

Stability of vaccine

The MHRA Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca states that unopened multidose vials have a shelf life of 6 months when stored at 2°C to 8°C.

MHRA Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca states that after first dose withdrawal, the multidose vial should be used as soon as is practically possible and within 6 hours. The multidose vials can be stored at 2°C to 25°C during their in-use period. After 6 hours, any unused vaccine left in the vial should be discarded.

Other excipients

Further excipient information for AstraZeneca COVID-19 vaccine can be found here.