COVID-19

What

COVID-19 is an infectious disease caused by the severe acute respiratory coronavirus 2 (SARS-CoV-2) virus. It affects people of all ages. Older adults and people with certain medical conditions have an increased risk of severe disease or death from COVID-19.

Who

COVID-19 vaccination is recommended for all people aged 18 years and older. It is also recommended for children aged 6 months to less than 18 years with medical conditions that may increase their risk of severe disease or death from COVID-19.

How

Primary course vaccination is recommended for all people aged 18 years or older, and for children aged 6 months to less than 18 years with medical conditions that may increase their risk of severe disease or death from COVID-19. 

Most people require 1 dose for their primary course. People with severe immunocompromise are recommended 2 primary doses and can consider a 3rd. 

Further doses every 6 or 12 months are recommended, or can be considered, based on an individual’s age and presence of risk factors for severe disease. 

Why

The COVID-19 pandemic has caused millions of deaths globally. Vaccination reduces the risk of severe disease and death from COVID-19.

COVID-19 vaccines available in Australia

The Therapeutic Goods Administration website provides product information for each vaccine, including the recently registered Comirnaty JN.1 vaccines.

See also Vaccine information and Variations from product information for more information.

Dose and route

All currently available COVID-19 vaccines are administered intramuscularly. The dose varies by brand and age. Refer to vaccine details above for further information.

Co-administration with other vaccines

People aged ≥5 years

COVID-19 vaccines can be co-administered with other vaccines in people aged ≥5 years.

Studies demonstrate the safety and immunogenicity of co-administration of COVID-19 and influenza vaccines.^25-27 COVID-19 vaccines can also be co-administered with other vaccines if required, including routine childhood and adolescent vaccines. 

Replicating mpox vaccines (such as ACAM2000) and mRNA COVID-19 vaccines both carry a small risk of myocarditis, but the risk from non-replicating MVA-BN mpox vaccines remains unknown. If the timing of MVA-BN is not urgent, consider spacing apart MVA-BN mpox vaccine and mRNA COVID-19 vaccines by four weeks, to allow attribution for any adverse reaction. This is particularly relevant for young males or people with specific relevant concerns.

Children aged 6 months to <5 years

For children aged 6 months to <5 years it is preferable to separate administration of COVID-19 vaccine from other vaccines by 7–14 days.

There are limited data on the safety and immunogenicity of co-administration in this age group. Theoretically, co-administration may lead to higher rates of adverse events, including fever. However, COVID-19 vaccines can be co-administered if separation of vaccines would be logistically challenging.

Interchangeability of COVID-19 vaccines

It is generally preferable to use the same brand of COVID-19 vaccine for the primary course when multiple doses are recommended (e.g. people aged ≥5 years who are severely immunocompromised).

A Comirnaty JN.1 or Omicron XBB.1.5-containing vaccine is preferred to complete a primary course in people who have started with a different formulation. If possible, the primary course should be completed using the JN.1 or XBB.1.5 formulation of the same brand.

An alternative brand can be used for subsequent doses if:

• there are contraindications or precautions to the brand used for a previous dose
• the brand used for a previous dose is not available in Australia
• the person is unable to access the same brand or does not accept further doses of a particular brand 

Evidence supports the safety, immunogenicity and efficacy of mixed schedules. Short-term adverse events are slightly more likely to occur in people who have a mixed schedule, but the nature and severity of the adverse events appears similar to single brand schedules.^28-34 Currently there are limited data on the safety and immunogenicity of mixed primary schedules incorporating Nuvaxovid, but where an mRNA vaccine is contraindicated, there are no theoretical safety concerns about using Nuvaxovid.

The recommended interval between doses of a mixed schedule is 8–12 weeks, regardless of which brands are used. 

Doses do not need to be repeated if the interval is >12 weeks. 

Mixed schedules for children who turn 5 or 12 between doses

Children who are recommended multiple primary doses and turn 5 or 12 between doses should receive the appropriate brand and dose for their age on the day of vaccination. For example, a child with severe immunocompromise who turns 5 after receiving a first dose of Comirnaty JN.1 6 months to <5 years formulation (yellow cap) or Comirnaty Omicron XBB.1.5 6 months to <5 years formulation (maroon cap) should receive respective Comirnaty JN.1 or Omicron XBB.1.5 5 to <12 years formulation (light blue cap) for the second dose, and a child with severe immunocompromise who turns 12 after a first dose of Comirnaty JN.1 5 to <12 years formulation (light blue cap) or Comirnaty Omicron XBB.1.5 5 to <12 years formulation (light blue cap) should receive respective Comirnaty JN.1 or Omicron XBB.1.5-based formulation registered for use in people aged ≥12 years for their second dose.

Administration errors

For detailed information refer to the ATAGI clinical guidance on COVID-19 vaccine administration errors.

Contraindications

General contraindications which apply to all COVID-19 vaccines are:

Anaphylaxis to vaccine components

• documented anaphylaxis after a previous dose of a COVID-19 vaccine from the same class, e.g., anaphylaxis after one mRNA COVID-19 vaccine is a contraindication to all other mRNA COVID-19 vaccines
• documented anaphylaxis after any component of that COVID-19 vaccine, e.g., Comirnaty and Spikevax vaccines would be contraindicated in someone with anaphylaxis to polyethylene glycol (PEG), and Nuvaxovid would be contraindicated in someone with anaphylaxis to polysorbate 80.

 Serious adverse event recognised as vaccine-related and assessed as likely to recur with future doses

This includes:

• any other serious adverse event attributed to a previous dose of a COVID-19 vaccine that has been reported to state/territory adverse event reporting programs and/or the TGA

AND

• has been determined following review by, and/or on the opinion of, an experienced immunisation provider/medical specialist to be a contraindication to future doses based on a risk of recurrence with repeat vaccine doses.

Precautions

Specific allergies

The following people should be assessed to check they are suitable for vaccination:

• people with immediate (within 4 hours) and generalised symptoms of a possible allergic reaction (such as urticaria/hives) to a previous dose of a COVID-19 vaccine, without anaphylaxis
• people with a generalised allergic reaction (without anaphylaxis) to any component of the COVID-19 vaccine to be administered 
• people with a history of anaphylaxis to a previous vaccine or drug (injectable or oral) where a common component such as PEG (for mRNA vaccines) or polysorbate 80 (for Nuvaxovid) may have been the cause
• people with a history of confirmed mastocytosis with recurrent anaphylaxis that requires treatment.

Assessment may be done in consultation with an allergist/immunologist or specialist immunisation clinic.

People in these categories may need one or more of the following:

• to be vaccinated in a facility with capacity to manage acute anaphylaxis
• to be observed for at least 30 minutes following administration of a COVID-19 vaccine dose
• to be vaccinated with an alternative brand of COVID-19 vaccine.

Refer to ASCIA Guide: Allergy and COVID-19 Vaccination for more information.

People with a suspected allergy to a previous dose

People who are suspected to have had an allergic reaction to their first dose of a COVID-19 vaccine should seek advice from the state/territory specialist immunisation service or a specialist allergist/immunologist. These people may need a clinical assessment before the second vaccine dose.

Before and during each vaccination session, check that up-to-date protocols, equipment, medicines and staff trained to manage anaphylaxis are available. 

Refer to Preparing an anaphylaxis response kit.

Cardiac precautions

People with a history of any of the following conditions can receive a COVID-19 vaccine, but advice should be sought from a GP, immunisation specialist or cardiologist about the best timing of vaccination and whether any additional precautions are recommended:

• recent (within the past 3 months) myocarditis or pericarditis
• acute rheumatic fever or acute rheumatic heart disease (with active myocardial inflammation) 
• acute decompensated heart failure.

People who develop myocarditis and/or pericarditis after a COVID-19 vaccine should defer further doses and discuss options for further COVID-19 vaccination with their treating doctor.

For more information, refer to the Joint ATAGI-CSANZ Guidance on Myocarditis and/or Pericarditis after COVID-19 Vaccines.

Adverse events after Comirnaty Original

Children aged 6 months to <5 years

The most frequently reported adverse events in children aged 6–23 months in the clinical trial were irritability (in about 40-50%), drowsiness (in about 25%), injection site tenderness (in about 15%), and fever (in about 7%).³⁵ Adverse events occurred at similar frequencies after the first and second dose and were slightly less frequent after the third dose. 

In children aged 2–4 years, adverse events occurred at similar frequencies after the first, second and third doses.³⁵ The most frequently reported adverse events in the clinical trial were injection site pain and fatigue (in about 25–30%). Fever was reported in about 5% of recipients.

Children aged 5–11 years

The most commonly reported adverse event after Comirnaty Original in children aged 5–11 years in the clinical trial was injection site pain (in about 70–75%), followed by fatigue (in about 35%) and headache (in about 20–30%).³⁶ Fever occurred in 3% of children after the first dose and 6.5% of children after the second dose. 

Adverse events after Comirnaty bivalent Original/Omicron BA.4/5

The most commonly reported local and systemic adverse events in the clinical trial were injection site pain (in about 70%), fatigue (in about 55%), headache (in about 40%) and muscle pain (in about 25%). The suggestion of an increased risk of ischaemic stroke in adults aged ≥ 65 years following receipt of Comirnaty bivalent Original/Omicron BA.4/5 has emerged from a single US safety surveillance system, but has not been validated by other analyses in the USA and other countries.^37,38 Currently, this is not considered to be a true clinical risk.³⁹

Adverse events after Comirnaty JN.1

As SARS-CoV-2 has evolved, newer COVID-19 vaccines have been developed to target newer, more immune-evasive variants. Many updated formulations differ from the original formulation only in the specific spike protein antigen used, and therefore updated formulation (e.g. JN.1/ XBB.1.5) COVID-19 vaccines were approved by regulatory agencies, such as the Therapeutic Goods Administration (TGA), after extrapolating safety data from large phase 3 clinical trials of the original and earlier formulation COVID-19 vaccines. Data on common local and systemic adverse events are not available for Comirnaty JN.1 but the adverse event profile of Comirnaty JN.1 is expected to be similar to that of earlier formulations.

Adverse events after Comirnaty Omicron XBB.1.5

Data on common local and systemic adverse events are emerging. The adverse event profile of Comirnaty Omicron XBB.1.5 is expected to be similar to earlier formulations. A recent phase 2/3 trial among individuals aged 12 years and older reported local and systemic reactions were mostly mild to moderate in severity, similar to earlier formulations.⁴⁰

Adverse events after Spikevax Original 6 months to < 5 years

In children aged 6–23 months, the most frequent solicited adverse events reported in the clinical trial were irritability (in about 65%), sleepiness (in about 35%) and loss of appetite (in about 30%).⁴¹ Fever occurred in 11% of children after the first dose and about 15% after the second dose. 

In children aged 24 to ≤ 36 months, the most frequent solicited adverse events were irritability (in about 55%), sleepiness (in about 30-35%) and loss of appetite (in about 25-30%).⁴¹ Fever occurred in about 11% of children after the first dose and about 20% after the second dose. 

In children aged 37 months to <6 years, the most frequent solicited adverse events were fatigue (in about 40-50%) and headache (in about 10-15%).⁴¹ Fever occurred in 7.7% after the first dose and 16% after the second dose. 

Adverse events after Spikevax Omicron XBB.1.5

Local and systemic reactions following the Spikevax XBB.1.5 vaccine occurred at similar or lower rates compared to the original and bivalent (original/BA.4/5) Spikevax formulations.⁴² The most frequent adverse events reported were injection site pain (in about 68%), fatigue (in about 44%), muscle pain (in about 38%), and headache (in about 34%).⁴²

Adverse events after Nuvaxovid 

The most frequent adverse events reported after Nuvaxovid in the clinical trial were injection site tenderness (75%), injection site pain (53%), muscle pain (51%), headache (50%), malaise (41%), joint pain (24%) and nausea or vomiting (15%).⁴³ Adverse events occurred at a similar frequency in adolescents aged 12-17 years and in adults aged ≥18 years. 

Nuvaxovid has been associated with myocarditis and pericarditis following vaccination.⁴⁴ Refer to ATAGI Guidance on myocarditis and pericarditis after COVID-19 vaccines for further information.

Anaphylaxis after COVID-19 vaccines 

Anaphylaxis after COVID-19 vaccines is rare and occurs at a similar rate to other common vaccines. In a study that included Comirnaty Original and Spikevax Original, the overall rate of anaphylaxis was around 10 per million doses.⁴⁵ The rate of anaphylaxis after Nuvaxovid is not yet known.

Myocarditis and Pericarditis

Myocarditis and/or pericarditis following vaccination with a COVID-19 vaccine are very rare but have been reported following receipt of all currently available COVID-19 vaccines. The highest incidence has been reported in adolescent males after a second dose of an mRNA vaccine (Comirnaty or Spikevax), although cases have been reported in male and female adults of all ages and after any dose of a COVID-19 vaccine.^44,46

It is recommended that all COVID-19 vaccine recipients be made aware of the potential signs and symptoms of myocarditis or pericarditis and be counselled about when to seek medical attention. For more information, including reporting rates for individual vaccines, refer to ATAGI Guidance on myocarditis and pericarditis after COVID-19 vaccines, and the Therapeutic Goods Administration COVID-19 vaccine safety reports.

Safety of COVID-19 vaccines during pregnancy or breastfeeding

mRNA COVID-19 vaccines are safe and effective in pregnancy.^47-49 Less is known about the safety of Nuvaxovid in pregnant or breastfeeding women, however there are no known or theoretical safety concerns.

The adverse event profile of pregnant women is similar to that of non-pregnant women following vaccination with an original mRNA COVID-19 vaccine.^50,51 Pregnant women are slightly more likely to report injection site pain, and less likely to report generalised symptoms such as fever or tiredness.

For further information refer to the ATAGI Shared decision making guide for women who are pregnant, breastfeeding or planning pregnancy.

Coronavirus disease (COVID-19) is caused by the severe acute respiratory coronavirus 2 (SARS-CoV-2), a single-stranded RNA betacoronavirus first identified in December 2019.  

SARS-CoV-2 contains 4 main structural proteins: spike (S) glycoprotein, small envelope (E) glycoprotein, membrane (M) glycoprotein and nucleocapsid (N) protein.⁵² Most COVID-19 vaccines target the spike protein which allows the virus to enter cells. 

Since its discovery, variant strains have progressively become dominant due to advantages in transmissibility or immune escape from immunity acquired from prior infection or vaccination.

In 2024, Omicron is the only variant currently circulating globally.⁵³ Previous variants of concern (e.g. Alpha, Beta, Gamma, Delta) and the ancestral strain have largely disappeared. Numerous sub-lineages of Omicron have since caused distinct global waves of infection.⁵⁴

Pathogenesis

In most people, SARS-CoV-2 primarily infects cells lining the upper airway and causes mild to moderate disease. Individuals with severe disease develop an infection of the lower respiratory tract causing pneumonia and may have poor or mistimed immune responses that cause both local inflammatory responses and a systemic pro-inflammatory state that leads to severe immunopathology.⁵⁵

People at increased risk of severe COVID-19 disease

Risk factors for severe disease

Older age 

Older age is by far the strongest risk factor associated with morbidity and mortality from COVID-19.^56,57 A study that assessed the mortality risk from COVID-19 among people who have received a primary course and further dose found a 30-fold greater risk of death in a person aged 80 compared with a person aged 50.⁵⁶

Medical conditions 

Medical conditions also independently increase the risk of severe disease but to a lesser extent than age.⁵⁸ For a list of these conditions see Table. Severely immunocompromising conditions for which additional doses of COVID-19 vaccine are recommended and Table. Conditions for which COVID-19 vaccination can be considered.

Pregnancy

Unvaccinated pregnant women with COVID-19 have an increased risk of severe disease compared with unvaccinated non-pregnant women of reproductive age with COVID-19.⁵⁹ This risk appears to be substantially reduced during the Omicron period in women who have been vaccinated.¹

Transmission

SARS-CoV-2 is spread via respiratory droplets or aerosols generated through breathing, talking or coughing.⁶⁰ Airborne viral particles may be inhaled, contact mucous membranes in the mouth, eyes, or nose, or land on surfaces and cause infection through contact with contaminated surfaces which are transferred to the body.

Symptoms of COVID-19 disease

The most common symptoms reported following infection with the SARS-CoV-2 Omicron variant are runny nose, sore throat, sneezing and headache.⁶¹ Some features of COVID-19 which were associated with previous variants such as fever, loss of smell and persistent cough appear to be less commonly reported with Omicron infection. 

Severe disease and hospitalisation is less common with the Omicron variant than with previous variants, and this may be partially due to accumulating immunity from a combination of vaccination and prior infection.⁶²

The incubation period after exposure to SARS-CoV-2 (Omicron) is most commonly 3 days, but can be up to 14 days.⁶³

Complications and sequelae of COVID-19 disease

Severe COVID-19 can be fatal. An estimate of infection fatality rate (IFR) early during the Omicron period in a Danish study was 6·2 (95% CI: 5·1–7·5) per 100 000 infections.⁶⁴

A range of metabolic, cardiovascular, respiratory, immunological and neurological sequelae following COVID-19 have been reported in the literature.^65-69 

Post-COVID-19 condition ('long COVID') is currently not well defined, but generally consists of persistent symptoms that develop during or after COVID-19, continue for greater than 3 months after the onset of the illness, and are not explained by an alternative cause.⁷⁰ This can consist of various physical symptoms (e.g. fatigue, dyspnoea, chest pain, and cough), cognitive symptoms (memory and concentration issues) and psychological symptoms (anxiety, depression, post-traumatic stress disorder). 

The prevalence of post-COVID-19 condition is highly variable due to differing definitions. A systematic review and meta-analysis including over 750,000 participants reported that 45% of COVID-19 survivors experience a range of unresolved symptoms at 4 months.⁷¹ Risk factors for post-COVID-19 condition may include the presence of comorbidities, prior hospitalisation from COVID-19, female sex, older age, high body mass index and smoking.⁷²

Vaccinated people have a significantly lower risk of post-COVID-19 condition (OR: 0.57; 95% CI: 0.43-0.76).⁷²

COVID-19 disease in Australia

Serosurveys indicate that an increasingly large proportion of the population had COVID-19 by December 2022, with the highest proportion among adults being in those aged 18–29 years, where approximately 82% of the population have serological evidence of infection.⁷³ Similarly, approximately 80% of unvaccinated children had COVID-19 by August 2022.⁷⁴

COVID-19 is likely to continue globally as an endemic disease with fluctuating incidence driven by waning population vaccine- and infection-related immunity, virus mutation leading to new SARS-CoV-2 variants with immune escape, and seasonal factors.^75-77

Original vaccines are directed at, or contain, the ancestral spike protein only. Omicron-based vaccines have also been developed. Currently available Comirnaty JN.1 vaccines are formulated against the Omicron JN.1 subvariant. Currently available monovalent Omicron XBB.1.5 vaccines are formulated against the Omicron XBB.1.5 subvariant.

Omicron-based COVID-19 vaccines

There are limited direct data on the immunogenicity or efficacy of Omicron-based vaccines (JN.1 or XBB.1.5) for primary course vaccination. Their use for the primary course is based on the superior immunogenicity and vaccine effectiveness against current and emerging Omicron sub-variants, when evaluated as further doses. 

JN.1 vaccine effectiveness

Currently, estimate of vaccine effectiveness is not yet available for JN.1 however it has been seen that the effectiveness of vaccines matched to the currently circulating Omicron variants appears to be higher than mismatched vaccines.^78,79 Consistent with this observation, a decrease in effectiveness of XBB vaccines against COVID-19 caused by JN.1 lineage viruses has been reported.^78,79

JN.1 vaccine immunogenicity

Currently, estimate of vaccine immunogenicity is not yet available for JN.1. However, a recent preprint study looking at humoral immunity of JN.1 vaccination among 42 healthcare workers in Germany reported significant increase (1 to 2-fold) of anti-S IgG at 13 days post vaccination and strengthened neutralising responses against circulating SARS-CoV-2-variants such as JN.1 and KP.2.⁸⁰

XBB.1.5 vaccine effectiveness

XBB.1.5 vaccine effectiveness studies continue to emerge. Findings from two^81,82 large cohort studies of adults mostly ≥60 years of age demonstrated that XBB.1.5 vaccines protect against hospitalisation and ICU admission from COVID-19 for at least 2–4 weeks. Vaccine effectiveness against hospitalisation was reported as 55–77%, and against ICU admission as 73%.

XBB.1.5 vaccine immunogenicity 

Spikevax Omicron XBB.1.5 immunogenicity 

Early human immunogenicity data demonstrate an 8.7-10.4 times increase in neutralising antibodies against the Omicron XBB.1.5 subvariant and other recently circulating subvariants at 29 days after receiving a dose of the Moderna monovalent XBB.1.5 vaccine in people who had completed at least a primary course of vaccination.⁴²

Comirnaty Omicron XBB.1.5 immunogenicity 

Immunogenicity data in mice demonstrate a rise in neutralising antibodies against the Omicron XBB.1.5 subvariant that was approximately 33 times higher after mice received a 2-dose primary series of Pfizer monovalent XBB.1.5 vaccine, compared to a primary series of Pfizer bivalent (original/BA.4/5) vaccine.⁸³ In mice that had received a 2-dose primary course of Pfizer original (ancestral strain) vaccine, a further dose with Pfizer monovalent XBB.1.5 resulted in a level of neutralising antibody against XBB.1.5 that was approximately 5 times higher compared to a further dose with Pfizer bivalent (original/BA.4/5) vaccine.⁸³

Early human immunogenicity data^40,84 demonstrate Omicron XBB.1.5 vaccine strongly increased anti-spike IgG in all vaccines 8–10 days after a dose and elicited potent neutralising responses against previous and contemporary SARS-CoV-2 lineages.

Bivalent vaccine effectiveness

Vaccine effectiveness studies demonstrate that BA.4/5-based bivalent vaccines offer excellent protection against hospitalisation and death from COVID-19 for several months. 

A population-wide cohort study conducted across 4 Nordic countries during an Omicron-dominant study period reported the combined vaccine effectiveness (CVE) of Pfizer and Moderna BA4/5 vaccines at 80.5% (95% CI: 69.5–91.5%).⁸⁵

Similarly, the effectiveness of Pfizer or Moderna BA.4/5 vaccines against hospitalisation or death during an Omicron-dominant period was estimated at 61.8% (95% CI: 48.2 - 71.8) in a US test-negative case control study. In this latter study, VE estimates of Pfizer and Moderna BA.4/5 vaccines were similar (63.8% vs 60.4% respectively).⁸⁶

Bivalent vaccines also offer some protection against symptomatic infection. An observational study in Japan conducted during a BA.5-dominant period found that the combined effectiveness of Pfizer and Moderna BA.4/5 vaccines was 76% (95% CI: 65–83%).⁸⁷

Comirnaty Original/Omicron BA.4/5 immunogenicity

Adults aged over 55 who received Comirnaty Original/Omicron BA.4/5 as a second booster developed higher neutralising antibody titres against the BA.4/5 sub-variants when compared with adults from an older study where Comirnaty Original was given as a second booster (geometric mean ratio 2.91, 95% CI: 2.45–3.44).⁸⁸ Neutralisation of BA.1.1 and XBB.1 subvariants was also higher with the BA.4/5-based bivalent booster than with the original formulation. The BA.4/5-based booster induced non-inferior and modestly higher titres for ancestral strain neutralisation (GMR 1.38, 95%CI: 1.22–1.56), noting the comparison was conducted between non-contemporaneous cohorts. Other age groups showed similar trends (12-17 years; 18-55 years).

Spikevax bivalent Original/Omicron BA.4/5 immunogenicity

A clinical trial reported 5.1-6.3 times greater neutralising antibody levels against the BA.4/5 Omicron subvariants at 1 month after a booster dose of Spikevax bivalent Original/Omicron BA.4/5 compared with Spikevax Original in adults aged 18 years and older.⁸⁹

No formulations of Spikevax XBB.1.5, Comirnaty/Spikevax bivalent or Comirnaty Omicron BA.4/5 are currently available in Australia.

Original COVID-19 vaccines

Comirnaty Original

In children aged 5-11 years without evidence of previous SARS-CoV-2 infection, the 10 µg dose of paediatric Comirnaty was 90.7% effective (95% CI: 67.7–98.3%) at preventing laboratory-confirmed symptomatic COVID-19 in the pre-Omicron era.³⁶

Comirnaty Original had a vaccine efficacy of 82.3% (95% CI: -8.0–98.3%) against confirmed COVID-19 due to Omicron in children aged 2-4 years, and 75.6% (95% CI: -370.1–99.6%) in children aged 6-23 months.³⁵

Vaccine efficacy estimates are not available for booster doses in children aged <16 years. A clinical trial showed an increase in neutralising antibodies against the ancestral and early Omicron variants of SARS-CoV-2 after a first booster dose in children aged 5-11 years who had no evidence of past infection.⁸⁹

No formulation of Comirnaty Original is currently available in Australia.

Nuvaxovid (Novavax)

The clinical trial evaluating Nuvaxovid for primary vaccination was conducted prior to the emergence of the Omicron variant of SARS-CoV-2. Nuvaxovid has been shown to have high efficacy in two clinical trials conducted in the United States, Mexico and the United Kingdom during periods when the Alpha variant was predominant. Vaccine efficacy against PCR-confirmed symptomatic COVID-19 in serologically negative adults after 2 doses was approximately 90%.^90,91 A third study from South Africa where higher numbers of infection occurred from the Beta variant, vaccine efficacy among HIV-negative adults was 60.1% (95% CI: 19.9–80.1) overall.⁹²

In adolescents aged 12-17 years without evidence of previous SARS-CoV-2 infection, Nuvaxovid was 79.5% effective (95% CI: 46.8–92.1%) at preventing laboratory-confirmed symptomatic COVID-19, from a clinical trial during a period of Delta variant predominance.⁴³ Neutralising antibody titres after 2 doses in adolescents aged 12-17 years were comparable to those observed trial participants aged 18-25 years.⁴³

A randomised controlled trial showed that a booster of Nuvaxovid increased anti spike IgG antibody levels by 4.5-4.7 times after Comirnaty primary vaccination, but fold increases and absolute titres were lower than those seen after Comirnaty booster (6.8-10.2 times after Comirnaty primary).⁹³

No formulations of Nuvaxovid (Novavax) are currently available in Australia.

Most COVID-19 vaccines are currently presented as multi-dose vials and require special handling to maintain viability and sterility. For additional information on multidose vials see Administration of vaccines and ATAGI guidance on the use of multi-dose vials for COVID-19 vaccination.

mRNA vaccines are required to be stored frozen at ultra-cold temperatures but once thawed can be stored for certain periods at +2°C to +8°C in a refrigerator before use. Requirements differ by vaccine brand and vial.

General advice:

• Thawed vials of frozen vaccine should not be refrozen.
• Do not shake the vaccine vials. 
• Minimise exposure to room light and avoid direct sunlight and ultraviolet light.
• Once a multi-dose vial is punctured, use prepared doses within 6 hours.

For more information, see the National Vaccine Storage Guidelines Strive for 5.⁹⁴

Comirnaty JN.1

The following guidance applies to:

• Comirnaty Omicron JN.1 months to <5 years (yellow cap)
• Comirnaty Omicron JN.1 5 to <12 years formulation (light blue cap)
• Comirnaty Omicron JN.1 ≥12 years formulation (dark grey cap)

Comirnaty JN.1 ≥12 years formulation (dark grey cap) is presented in a multidose vial with a grey cap, containing 6 doses of 0.3 mL of vaccine. Prefilled syringe is also available for ≥12 years

Comirnaty JN.1 5 to <12 years formulation (light blue cap) is presented in a single dose vial with a light blue cap, containing 1 dose of 0.3 mL of vaccine.

Comirnaty JN.1 6 months to <5 years formulation (yellow cap) is presented as a multidose vial, containing 3 doses of 0.3mL of vaccine.

Do not dilute Comirnaty JN.1 5 to <12 years formulation (light blue cap) or Comirnaty JN.1 ≥12 years formulation (dark grey cap).

The shelf life of frozen vials of the JN.1 formulations is 18 months at −90°C to −60°C. Prefilled syringe cannot be stored.

Frozen vials should be thawed at +2°C to +8°C. Frozen vials can also be thawed at room temperature up to 30°C for immediate use. If the vaccine is received at +2°C to +8°C it should be stored at +2°C to +8°C.

Once thawed, the vaccine should not be re-frozen. See the product information for more details about thawing vials.

After thawing, the shelf life is up to 10 weeks at +2°C to +8°C for all the formulation except for the prefilled formulation.

Vaccine may be stored at temperatures between +8°C to +30°C for up to 12 hours.

The thawed Comirnaty JN.1 6 months to <5years formulation must be diluted in its original vial with 1.1mL of sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques. Low dead-volume syringes and/or needles should be used to extract 3 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.

Comirnaty Omicron XBB.1.5

The following guidance applies to:

• Comirnaty Omicros XBB.1.5 6 months to <5 years (maroon cap)
• Comirnaty Omicron XBB.1.5 5 to <12 years formulation (light blue cap)
• Comirnaty Omicron XBB.1.5 ≥12 years formulation (dark grey cap)

The shelf life of frozen vials of the Omicron XBB.1.5 formulations is 24 months at −90°C to −60°C.

Frozen vials should be thawed at +2°C to +8°C. A 10-vial pack may take 6 hours to thaw (4 hours for the 6 months to <5 years formulation (maroon cap)). Frozen vials can also be thawed at room temperature (up to 30°C) for 30 minutes for immediate use. If the vaccine is received at +2°C to +8°C it should be stored at +2°C to +8°C.

Once thawed, the vaccine should not be re-frozen. See the product information for more details about thawing vials.

After thawing, the shelf life is up to 10 weeks at +2°C to +8°C.

Vaccine may be stored at temperatures between +8°C to +30°C for up to 24 hours.

Comirnaty Omicron XBB.1.5 ≥12 years (dark grey cap) formulations are presented in a multidose vial with a grey cap, containing 6 doses of 0.3 mL of vaccine.

Comirnaty Omicron XBB.1.5 5 to <12 years formulation (light blue cap) is presented in a single dose vial with a light blue cap, containing 1 dose of 0.3 mL of vaccine.

Comirnaty Omicron XBB.1.5 6 months to <5 years formulation (maroon cap) is presented as a multidose vial with a maroon cap, containing 10 doses of 0.2mL of vaccine.

Do not dilute Comirnaty Omicron XBB.1.5 5 to <12 years formulation (light blue cap), Comirnaty Omicron XBB.1.5 ≥12 years formulation (dark grey cap), or Comirnaty bivalent Original/Omicron BA.4/5 (grey cap).

The thawed Comirnaty Omicron XBB.1.5 6 months to <5years formulation must be diluted in its original vial with 2.2mL of sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques. Low dead-volume syringes and/or needles should be used to extract 10 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.

Do not shake the vial.

Note that both Comirnaty JN.1 5 to <12 years and Comirnaty Omicron XBB.1.5 5 to <12 years formulations (maroon cap) have a light blue cap. To minimise the risk of administration errors, providers should preferably prepare and store doses of these vaccines separately. Doses withdrawn in advance of administration should be clearly labelled.

Note that Comirnaty JN.1 and Comirnaty Omicron XBB.1.5 ≥12 years formulations have a grey cap. To minimise the risk of administration errors, providers should preferably prepare and store doses of these vaccines separately. Doses withdrawn in advance of administration should be clearly labelled.

Chemical and physical stability has been shown for 12 hours at +2°C to +30°C with storage of Comirnaty JN.1 (6 months to <5 years and ≥12 years formulations) and Comirnaty Omicron XBB.1.5 formulations after initial puncture. However, because these vaccines contain no antimicrobial preservatives, ATAGI recommends that after puncture, vials must be kept at +2°C to +30°C and used within 6 hours after initial puncture. Do not re-freeze vaccine.

ATAGI recommends that, when possible, pre-drawn doses should be used within 1 hour if kept at room temperature, and within 6 hours if kept at +2°C to +8°C, to minimise the risk of infection.

During storage, minimise exposure to room light. Avoid exposure to direct sunlight and ultraviolet light.

Transporting doses for home visits

When transporting multidose vial COVID-19 vaccines for a home visit, there are 2 options:

Where possible, transport the vial at +2°C to +8°C and not exceeding the total maximum storage period of 6 hours, and draw up the dose at the site of administration.

A pre-drawn dose in a syringe can be transported if it can be appropriately stored (protecting from light and maintaining the cold chain) and can be administered as soon as practicable and not exceeding the total maximum storage period of 1 hour if kept at room temperature, and 6 hours if kept at +2°C to +8°C).

COVID-19 is a notifiable disease in all states and territories in Australia.

The Communicable Diseases Network Australia provides national guidelines and the State and territory public health authorities can provide local advice about the public health management of COVID-19, including management of cases and their contacts.

Serological testing for immunity

It is not recommended to test for anti-spike antibodies or neutralising antibodies to demonstrate immunity against SARS-CoV-2 in vaccinated people as there is currently no established immune correlate of protection and the available assays for anti-spike antibody or neutralising antibodies vary in their interpretation.

Impact of vaccination on future COVID-19 testing

Receiving a COVID-19 vaccine will not affect the results of nucleic acid (PCR) testing or rapid antigen testing for diagnosis of SARS-CoV-2 infection. However, as vaccines induce protective antibodies against the spike protein, this may result in serological testing detecting antibody to the spike protein. Vaccination will not affect the results of anti-nucleocapsid antibody testing.

Post-exposure prophylaxis

COVID-19 vaccines are not recommended for post-exposure prophylaxis. No data are available to support such use.

Comirnaty

The product information for Comirnaty state that the recommended interval between primary course doses is 3 weeks. ATAGI recommends an 8-week interval between primary course doses. 

The product information states that recommended interval between primary course and further doses is at least 3-6 months. ATAGI recommends a minimum interval between primary course and further doses of at least 6 months in eligible people. 

Spikevax

The product information for Spikevax states that the recommended interval between primary course doses is 4 weeks. ATAGI recommends an 8-week interval between primary course doses.

The product information states that recommended interval between primary course and further doses is at least 3–5 months. ATAGI recommends a minimum interval between primary course and further doses of at least 6 months in eligible people.

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