S Letter Archives - The Melbourne Vaccine Education Centre (MVEC)

Spikevax (Moderna) COVID-19 vaccine

Name of vaccine	Spikevax (elasomeran, Moderna COVID-19 Vaccine, mRNA-1273)
Vaccine platform	Genetic vaccine (messenger RNA/mRNA)
Developer of vaccine	ModernaTX, Inc.
Registration	Provisional registration granted by the TGA on 9 August 2021
For use in age	Spikevax 100µ dose (0.5ml) of 200mcg/ml formulation registered for use in individuals ≥ 12 years Spikevax 50µ dose (0.25ml) of 200mcg/ml formulation registered for use in individuals 6-11 years Spikevax 25µ dose (0.25ml of 100mcg/ml formulation registered for use in individuals 6 months - 5 years
Primary course in immunocompetent individuals	Individuals aged ≥ 12 years should receive a 2 dose primary schedule of 100µ (4-8 weeks apart) Individuals aged 6-11 years should receive 2 dose primary schedule of 50µ (4-8 weeks apart) Not indicated for immunocompetent individuals aged 6 months - 5 years
Primary course in immunocompromised individual	Individuals 6 years and above - 3 dose primary schedule of age appropriate vaccine, with the third dose administered 8 weeks post dose 2 Individuals 6 months - 5 years with severe immunocompromise - 3 dose primary schedule of age appropriate vaccine, with the third dose administered 8 weeks post dose 2 Individuals 6 months - 5 years with immunocompromise - 2 doses, 8 weeks apart
Booster dose recommendations	50µ dose approved for use as a booster in individuals aged ≥ 18 years
Manufacturer	Doses for Australia will be manufactured overseas
Storage requirements	Must be stored at temperatures of -50°C to -15°C. Unopened vials can be thawed and stored or transported in refrigerators at temperatures of 2°C to 8°C for up to 30 days. Opened vials can be stored between 2°C to 25°C for 12 hours before they must be discarded. Once thawed, Spikevax cannot be refrozen.
Preparation and injection	Each multi-dose vial contains 10 doses of 0.5ml of vaccine. The vaccine must be thawed before injection and does not require reconstitution. It is administered via intramuscular (IM) injection.

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

A 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.

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: March 1, 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.

by MVEC Education

Shoulder injury related to vaccine administration (SIRVA)

Shoulder Injury Related to Vaccine Administration (SIRVA) is a rare complication of suspected incorrect vaccine administration into the shoulder and not into the correct site of the deltoid muscle. Damage to local structures within the shoulder joint can occur, including to ligaments and tendons, as well as a local inflammatory response to the vaccine components. This results in shoulder pain and limited range of movement of the affected limb. Symptoms are usually immediate and can last for days, months or as long as years. Following investigation, many affected individuals are diagnosed with bursitis, impingement syndrome or ligament tears.

Implications of SIRVA

SIRVA can be an extremely painful condition. The pain and limited range of movement can impact a patient’s ability to perform work duties, sporting activities and basic activities of daily living. When symptoms persist for months, individuals can experience impacts on their mental and emotional wellbeing. There are other implications of SIRVA to consider including the immunogenicity of the vaccine, cost of time off work, investigations and treatments, vaccine hesitancy and consumer confidence in healthcare providers.

Injection technique

Incorrect site- injection given too high Correct site- in the deltoid muscle

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

Suspected cases of SIRVA

Any adverse event following immunisation (AEFI) should be reported to SAEFVIC. Reports can be made online via www.saefvic.org.au or by telephone on 1300 882 924 (option 1) during business hours.

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: August 2020

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.

by MVEC Education

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.

by MVEC Education

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.

by MVEC Education

S Letter

Immunogenicity

Safety profile