Spikevax (Moderna) COVID-19 vaccine

Immunogenicity

Pre-clinical trials were conducted in mice which showed that two doses of the vaccine protected the mice from infection with the SARS-CoV-2 virus with no virus detected in the lower respiratory tract and nose following a challenge with the SARS-CoV-2 virus. These results indicated the vaccine may reduce both infection and transmission in humans.

The US phase 1 trial included participants aged 18-55 years old who received two injections of Spikevax 28 days apart at doses of 25 μg, 100 μg or 250 μg. The vaccine elicited a strong immune response without any severe adverse events and the trial supported the selection of the 100 μg  dose for advancement to Phase 2/3 trials.

Safety profile

During clinical trials, symptoms following immunisation were generally mild to moderate and short-term. Local and systemic reactions were more common after the second dose and in the younger age group (18-64 years).

Local reactions included pain (86-90%) and redness (3-9%) at the injection site and axillary (armpit) swelling/tenderness (11-16%). The average onset of local reactions was 1 day after either dose, with an average duration of 2-3 days.

Systemic reactions (including fatigue, headache,  muscle ache, joint pain, chills, nausea and vomiting) were more common after the second dose (82%) compared to the first dose (57%).  Fever was more common following the second dose (17%). The average onset of local reactions was 1-2 days after either dose, with an average duration of 2 days. The incidence of serious adverse events was very low (1%) and similar in both the vaccine and placebo groups.

Vaccine efficacy

phase 3 trial enrolling 30,420 volunteers aged ≥18 years, assigned participants to receive either the vaccine or placebo as two intramuscular injections 28 days apart. Spikevax showed overall efficacy of 94.1% for preventing COVID-19 illness, and 100% efficacy for preventing severe disease. Vaccine efficacy was consistent across subgroups stratified by age group (18 to < 65 years of age, ≥ 65 years, presence of risk for severe COVID-19 disease, sex, race and ethnic groups).

Paediatric clinical trials

3732 adolescents (12-15 years) participated in a phase 3 trial in the US investigating the safety and efficacy of Spikevax (Moderna) in children. Results from this trial have demonstrated an efficacy against confirmed symptomatic COVID-19 disease of 93.3% (commencing 14 days after dose 2 of vaccine. 1 case in vaccine group, 7 cases in placebo group). There were no cases of severe COVID-19 or deaths in the study cohort.

Up to 4000 children (6-11 years) were recruited to the KidCOVE clinical trial across Canada and the United States. The immunogenicity, safety and efficacy of 2 doses of 50µ of Spikevax (Moderna) was assessed. Immunogenicity was comparable to that seen in individuals aged 18-25, with a good protection seen against COVID-19 disease.

2024 children aged 6 to 23 months and 3452 children aged 2-5 years participated in the phase 2-3 P205 clinical trial assessing the immunogenicity, efficacy and safety of a two-dose primary course of 25µ of Spikevax (Moderna). The immune response of the infants and children was comparable to that seen in adults aged 18-25 years in earlier trials. Results (>14 days after dose 2) demonstrated that in those without history of prior COVID-19 infection, vaccination was 50.6% effective in preventing disease in participants aged 6-23 months of age, and 36.8% in those aged 2-5 years. In those with a history of previous COVID-19 infection, vaccine efficacy against symptomatic COVID-19 disease was 52.1% for the 6-23 month group, and 34.5% in the 2-5 years group. There were no cases of severe COVID-19 disease reported in the study.

For further information, refer to MVEC: COVID-19 vaccination in children.

Post-licensure surveillance

Allergies

A true vaccine allergy (anaphylaxis) is a rare side effect occurring for all vaccines at a rate of approximately 1 case per million vaccine doses administered. Post-licensure surveillance of Spikevax in the US has shown that it has a slightly higher rate of anaphylaxis with approximately 2.5 cases per million. Most cases (89%) occurred within 30 minutes of vaccination and 26% had a history of prior anaphylaxis.

Myocarditis/pericarditis

A small number of cases of myocarditis and pericarditis have been reported in individuals vaccinated with COVID-19 mRNA vaccines (eg. Comirnaty and Spikevax). Reports have predominantly involved adolescents and young adults, more commonly males, after the second dose of vaccine. Symptom onset has typically been seen within 4 days of vaccination.

Resources

Authors: MVEC Education Team

Reviewed by: Rachael McGuire, (MVEC Education Nurse Coordinator) and Francesca Machingaifa (MVEC Education Nurse Coordinator)

Date: September 15, 2022

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC)

SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community) is the central reporting service in Victoria for any significant adverse event following immunisation (AEFI).

An AEFI is defined by the Australian Immunisation Handbook as “any untoward medical occurrence that follows immunisation. It does not necessarily have a causal relationship with the vaccine”. A vaccine error is also considered an AEFI and may be related to the way a vaccine was stored, prepared or administered.

Reporting adverse events is not mandatory in Victoria, however doing so allows the rapid investigation of any potential vaccine or system problems by Victorian and national health authorities (Therapeutic Goods Administration). This helps to ensure a safe and effective immunisation program and it maintains community confidence in vaccines.

Following the report of adverse events, SAEFVIC can facilitate individualised clinical assistance for patients and families affected by an AEFI. This may be done via a face-to-face or telehealth consultation with a specialist or with an immunisation nurse over the phone.

Please see your GP, local emergency department or call 000 if immediate assistance is required.

Authors: Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute), Georgina Lewis (Clinical Manager, SAEFVIC, Murdoch Children’s Research Institute) and Rachael McGuire (Research Nurse, SAEFVIC, Murdoch Children’s Research Institute)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: October 20, 2022

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Shoulder injury related to vaccine administration (SIRVA)

What is it?

Shoulder Injury Related to Vaccine Administration (SIRVA) is a rare but serious complication following suspected inadvertent administration of a vaccine too high in the deltoid or into the shoulder joint. This may cause a local inflammatory response and potential trauma to local structures within the shoulder joint including bursae, ligaments and tendons resulting in sudden onset shoulder pain and restricted movement. Symptoms can last for weeks to months or as long as years. Affected individuals can experience varying degrees of disability which can impact on their activities of daily living, social and emotional wellbeing. 

Symptoms

Distinguishing symptoms/features of SIRVA include: 

  • sudden onset shoulder pain within 48 hours of vaccination- different to the injection site pain expected following vaccination 
  • restricted range of movement (RROM) of affected shoulder 
  • persistent shoulder pain and RROM lasting >1 week, lasting weeks to months 
  • suspicion of incorrect vaccination site – too high in the upper arm. 

Impacts and implications

The impacts of SIRVA can include: 

  • interrupted sleep due to pain  
  • difficulty with personal care, care of others and activities of daily living 
  • inability to participate in sports or hobbies  
  • modified work duties 
  • time off work related to symptoms and/or treatments and investigations 
  • loss of income due to time off work  
  • financial burden due to cost of treatments and investigations  
  • emotional and social wellbeing. 

Further implications for an individual with SIRVA can include vaccine hesitancy, reduced confidence in healthcare/immunisation providers and the potential for impaired immunogenicity.

Diagnosis 

A GP, specialist or allied health professional such as a physiotherapist can diagnose SIRVA based on presenting symptoms and clinical history following an immunisation. 

If radiological investigations such as ultrasound or MRI are undertaken to support or confirm a diagnosis, abnormalities including bursitis, adhesive capsulitis, impingement syndrome, synovitis or tendon tears may be identified.  

Early diagnosis of SIRVA leads to timely treatment which is thought to lessen the duration and severity of symptoms.  

Treatment options

SIRVA can be treated in a variety of ways and may include any of the following: 

  • over the counter pain/anti-inflammatory medications 
  • prescription pain/anti-inflammatory medication 
  • oral corticosteroids 
  • corticosteroid joint injections 
  • physiotherapy or other allied health professionals  
  • massage
  • surgery(rare). 

How to prevent SIRVA

SIRVA can be prevented by following the recommended vaccination procedures for correct injection technique. 

Please refer to MVEC: Administration of injected vaccines- correct technique for further information on correct injection technique.

Where to report a case of SIRVA

All confirmed or suspected cases of SIRVA should be reported to SAEFVIC (the Victorian vaccine safety service). Reports can be made by consumers, immunisation providers or treating healthcare professionals. 

SAEFVIC can provide clinical advice or facilitate consultation with an immunisation specialist if required. 

Resources

Authors: Mel Addison (SAEFVIC Research Nurse, Murdoch Children’s Research Institute), Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute), Georgie Lewis (SAEFVIC Clinical Manager, Murdoch Children’s Research Institute) and Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute)

Reviewed by: Mel Addison (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)

Date: November 29, 2022

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Special Risk Chapter in the Australian Immunisation Handbook

What is it?

Individuals that are at higher risk of vaccine preventable diseases (VPD) are classified as ‘special risk’ groups in the Australian Immunisation Handbook.

This includes populations at special risk (e.g. Aboriginal and Torres Straight Islanders) and those with additional vaccine requirements (e.g. maternal vaccination; preterm infants). It also has detailed sections on those at special risk because of immune suppression (disease and/or therapy) e.g. Asplenia, cancer/chemotherapy.

The chapter is updated online using the latest available scientific evidence

The Handbook is endorsed by:

  • The Australian Technical Advisory Group on Immunisation [ATAGI] and
  • The National Health and Medical Research Council [NHMRC]

Resources

Reviewed by: Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute)

Date: September 2018

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.

 


Solid organ transplant recipient: pre-transplant immunisation recommendations

Background

In order to prevent the rejection of transplanted organs, people who have undergone a solid organ transplant require varying doses of immune suppressive medication. Once a patient is immune suppressed, seroprotection gained from immunisation may be suboptimal and therefore additional doses of vaccines may be recommended. Some vaccines (live-attenuated vaccines) may be contraindicated.

To overcome this and maximise immune responses it is recommended where possible that all vaccines are administered well before transplant with live-attenuated vaccines administered a minimum of 4 weeks prior to transplant.

Please refer to MVEC: Pre-solid organ transplant recipient immunisation guideline (0-18 years) for more information.

For immunisation recommendations following a solid organ transplant please refer to your immunisation specialist for specific advice.

MVEC special risk guidelines

These guidelines have been prepared by immunisation staff from the Royal Children’s Hospital and Monash Health and endorsed at a monthly immunisation meeting. Attendees at this meeting include paediatricians, infectious disease physicians, nurse immunisation specialists, infection control team members and a representative from the Immunisation Section of the Victorian Department of Health.

These guidelines are based on the latest available evidence and aim to align with recommendations in the Australian Immunisation Handbook.

Vaccine funding

Some of the recommendations in these guidelines are outside the scope of the National Immunisation Program (NIP). Different jurisdictions and individual hospitals have varying approaches to non-NIP vaccines, which should be clarified with the local health service.

We welcome any feedback on the guidelines, please email: info.mvec@mcri.edu.au

Resources

Authors: Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute) and Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator) and Annie Cobbledick (Immunisation Pharmacist, the Royal Children’s Hospital)

Date: March 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.