COVID-19 vaccine – Clinical considerations
This guidance includes the latest clinical advice on the COVID-19 vaccine rollout including advice from the Australian Technical Advisory Group on Immunisation.
Updated ATAGI advice on AstraZeneca vaccine
On Thursday 8 April 2021, the Australian Government received advice and recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI) about the AstraZeneca vaccine.
There is evidence of a link between the AstraZeneca vaccine and a syndrome called thrombosis with thrombocytopenia. This is an extremely rare blood clotting syndrome. It is very serious and can cause long-term disability and death.
For more information about the AstraZeneca vaccine and the syndrome see the ATAGI statement.
Drawing up the AstraZeneca COVID-19 vaccine
When drawing up doses from a multidose COVID-19 vaccine vial, ATAGI strongly recommends using a 19-21 gauge bevelled needle to reduce the risk of coring. If entering the vial multiple times, ensure that each re-puncture occurs at a different site on the bung.
You may carry a dose/s that you’ve just withdrawn from a multi-dose vial that is in a syringe with a capped administration needle, from the vaccine preparation area to the vaccine administration area within the clinic (noting these areas may be within the same treatment room). The room temperature should be less than 30°C.
Where vaccine doses will be administered immediately one after another (for example, in dedicated immunisation clinics with multiple patients, including within general practice), you can withdraw multiple doses consecutively from one vial in the preparation area. Each filled syringe (with a capped administration needle) must be:
- appropriately labelled
- stored at the appropriate temperature
- protected from light.
Each dose should be used as soon as practical once withdrawn from the vial. You may pre-draw multiple doses from one vial and use within one hour if stored at room temperature, or within six hours if stored at 2-8°C. Although there are data supporting stability of vaccine doses after withdrawal into a syringe for up to 6 hours at room temperature (as reflected in the Astra Zeneca vaccine product information [PI], ATAGI recommends that, as much as possible, pre-drawn doses be used within an hour in order to minimise any remote potential risk of infection.
If any doses remain in the vial, refrigerate the multi-dose vial between +2°C and +8°C immediately after you finish the vaccine draw-up.
If you will not be administering a vaccine dose one after another (for example, in many general practices), each dose should be withdrawn and then administered to a recipient before another dose is withdrawn from the vial for the next recipient later when required.
For home visits, there are 2 options:
- where possible, you should transport the vial and draw up the dose at the site of administration
- if you can appropriately store the vaccine dose in a syringe/s (protect from light and maintain appropriate cold chain) and deliver it promptly, you can transport pre-drawn doses for a home visit. If you cannot ensure these conditions, you should transport the vial and draw up the doses at the administration (e.g. home visit) site.
You must ensure that each vial or dose is stored at the recommended temperature and does not exceed the total maximum storage period specified in the Product Information.
Interruption to COVID19 vaccination and advice for re-vaccination
If the process of administering a vaccine intramuscularly is interrupted (such as by syringe-needle disconnection) and most of the dose has not been given, repeat the whole dose as soon as practicable. If most of the dose has been given, repeat dosing is not required. If there is uncertainty, it is acceptable to administer a repeat whole dose.
Leakage of diluent when reconstituting Pfizer vial
When reconstituting a Pfizer vial, if there is leakage of the diluent while injecting into the vial, the vaccine may be used if most of the diluent has been injected into the vial. Where there is uncertainty about how much of the diluent has been injected into the vial, if sufficient diluent has been added to be able to draw up 4 doses, then the vaccine may be used. Ensure that there has been no breach of infection control.
AstraZeneca excess dose policy
This AstraZeneca excess dose policy is for general practice, including GP-led respiratory clinics and Aboriginal Community Controlled Health Services
Excess doses are those doses of COVID-19 vaccine which will expire before the next scheduled vaccination clinic/patients booked for COVID-19 vaccine.
Please note that storage advice differs for AstraZeneca vaccine depending on whether it has been pre-drawn into a syringe or remains in the vial.
Where possible, practices should aim to minimise excess doses. This can be through batching bookings within a vaccination session to match the number of doses available in a vial.
However, sometimes excess doses will remain at the end of a session, and these doses might expire before the next session is scheduled. For example, this could happen because of cancelled appointments or no-shows.
In this case, it is recommend that clinics use the following strategies to prioritise others for vaccination in order to minimise vaccine wastage.
- Maintain a reserve list of eligible patients. These may be patients who have not been able to secure a vaccine appointment, or have booked later but could come in at short notice. (Note: If a vial is opened but refrigerated, then the vaccine can still be administered up to 48 hours post opening. Clinics may identify and vaccinate eligible patients within that timeframe, regardless of when they have booked their next vaccination clinic).
- Use identified excess doses for other patients or staff who fit the eligibility criteria and who are present in the practice.
Where these options are not available, practices should use identified excess doses for other patients or staff who fit the 2A or 2B eligibility criteria. This could include those present around the practice when excess doses are identified, such as those working in other businesses in the same building.
Practices should note and plan for people receiving the excess doses to be able to receive the second dose of the vaccine in due course.
Vaccine for patients with a history of anaphylaxis or multiple allergies
Patients with a history of anaphylaxis or multiple allergies do not need to be vaccinated in a hospital. However, there are some specific considerations for patients with a history of anaphylaxis or multiple allergies. Find out more about COVID-19 vaccine guidance from the Australian Technical Advisory Group on Immunisation (ATAGI).
AstraZeneca vaccine and immunocompromised people
The AstraZeneca vaccine does not contain any live SARS-CoV-2 virus. It cannot give you COVID-19.
The AstraZeneca vaccine uses a modified adenovirus carrier that brings the SARS-CoV-2 spike protein into your cells. The vaccine does not behave like a ‘live vaccine’. The adenovirus carrier has been modified so that it cannot replicate or spread to other cells, and it cannot cause infection. It is safe in people who are immunocompromised.
The Australian Government strongly recommends people who are immunocompromised receive the COVID-19 vaccination.
Find out more about the AstraZeneca vaccine.
Timing for administration of the second dose of COVID-19 vaccine when COVID-19 is contracted between the first and second dose
Where an individual contracts COVID-19 between the first and second dose of the COVID-19 vaccine, in general the following is recommended:
- The second dose of Comirnaty (Pfizer) vaccine should be given a minimum of 8 weeks after the individual has recovered from their acute illness
- The second dose of AstraZeneca COVID-19 vaccine should be given a minimum of 12 weeks after the individual has recovered from their acute illness
Where an individual is very likely to be in contact with cases of COVID-19 (e.g. an individual working in quarantine), consideration may be given to shortening the above recommended intervals. In this instance, clinicians may wish to seek advice from a specialist immunisation service.
Reporting adverse reactions
The TGA encourages health professionals to report all potential adverse events following COVID-19 vaccination. This is particularly important if the adverse reaction is unexpected or serious. Robust data supports effective monitoring of vaccine safety.
In most states and territories there is also a legislative requirement to report adverse events following immunisation with the COVID-19 vaccine.
For more information on how and what to report, see: Reporting suspected side effects associated with a COVID-19 vaccine on TGA's website.
Co-administration of COVID-19 vaccine and other vaccines
ATAGI advises that co-administration of COVID-19 vaccine with other vaccines is not routinely recommended.
There are no studies on the co-administration of COVID-19 vaccines with other vaccines. However, there are no theoretical concerns of interference, except with live vaccines. In the absence of data, and to minimise confusion with any associated reactions, ATAGI generally recommends ideally at least a 14 day gap. This is between giving COVID-19 vaccines and any other non-live vaccine. This is further described in the ATAGI clinical guidance on COVID-19 vaccine in Australia.
It is recognised that in some cases there may be a clinical need for co-administration or a shorter interval than 14 days between administration of different vaccines. In this situation, consider several principles, including:
- the likely onset of protection against disease from the vaccine (protection from COVID-19 vaccines starts around 14-21 days after the first dose)
- level of current immunity in the individual to diseases being vaccinated against
- the individual’s risk of exposure to diseases being vaccinated against
When requiring an interval of less than 14 days, where possible and appropriate, provide the COVID-19 vaccine after the other vaccines.
The interval between COVID-19 vaccines and live attenuated vaccines (including MMR and yellow fever) requires further consideration. Currently, ATAGI recommends a 14 day interval.
Scheduling influenza and COVID-19 vaccinations
This year both influenza and COVID-19 vaccines will be available to protect people in Australia from these potentially serious diseases. It is important that both vaccinations are planned to ensure the best possible protection against COVID‑19 and influenza.
In 2021, the National Immunisation Program (NIP) influenza vaccines will be available from April, subject to local vaccine supply arrangements. This timing is consistent with:
- previous years
- expert advice on optimal timing of influenza vaccination to ensure the best possible protection ahead of the peak influenza season. (This usually occurs from June to September in most parts of Australia).
Consider these principles when scheduling influenza and COVID-19 vaccinations:
- people in earlier phases for COVID-19 vaccination should ensure they receive the COVID-19 vaccine as soon as it is available to them, and then receive their influenza vaccine.
- people in later phases for COVID-19 vaccination should receive their influenza vaccine as soon as it is available, and then receive their COVID-19 vaccine when it becomes available to them.
Your practice is responsible for ensuring appropriate spacing between COVID-19 and influenza vaccinations.
Clinical advice is changing rapidly. Your practice should keep up to date with the latest ATAGI advice available at health.gov.au.
Note: under the Australian Immunisation Register Act 2015, it is now mandatory to report influenza vaccinations administered to the AIR.