Novavax COVID-19 vaccine

Name: NVX-CoV2373

Type: Protein vaccine (nanoparticle-based vaccine)

Developer: Novavax

Likely doses/timing: 2 doses (21 days apart)

Doses for Australia: 51 million doses will be made available in Australia during 2021

Manufacturing: Doses for Australia will be manufactured in several locations across Europe and Asia

Storage: Can be stored, transported and handled at standard refrigerator temperatures (2-8°C)

Background

The Novavax COVID-19 vaccine (NVX-CoV2373) was created using Novavax’ recombinant nanoparticle technology which contains the full length SARS-CoV-2 spike protein and Novavax’ patented Matrix-M1 adjuvant (an additional vaccine component that boosts the immune response).

Novavax is a biotechnology company from the USA. Their nanoparticle and Matrix-M1 technology has been previously studied in Phase 3 trials of their quadrivalent influenza vaccine, NanoFlu.

Clinical trials

Pre-clinical trials were conducted in baboons and mice. In animal models, the vaccine induced high levels of anti-spike antibodies and neutralising antibodies, which exceeded the responses measured in humans recovered from natural COVID-19 infection.

Phase 1 clinical trials were conducted in 131 healthy adults, beginning in May 2020. Early clinical trials were performed in Melbourne and Brisbane, Australia, as well as in the USA. Phase 1 results were released in September 2020. This study assessed the safety and immunogenicity of two doses (5-μg and 25-μg) with or without Matrix-M1 adjuvant in healthy adults aged 18 to 59 years, compared to placebo. The phase 2 clinical trials expanded the age of participants to include those aged 60-84 years and results are still pending.

Phase 3 trials are underway in the UK and enrolment of 15,000 participants was completed in November 2020. Interim data is expected in the first quarter of 2021. More large-scale clinical trials are underway or planned for other countries in late 2020 and early 2021, including South Africa, USA and Mexico. These Phase 3 trials will include 30,000 participants overall.

Safety profile

No serious adverse events or adverse events of special interest were reported in Phase 1 trials. Overall reactogenicity was largely absent or mild and the average duration was two days or less for both doses. After first vaccination, local reactions only occurred in 4-16% of participants that received NVX-CoV2373 (the rate of reaction varied for each subgroup; depending on dose given or whether adjuvant was given). Systemic reactions occurred in 4-32% of participants, depending on the subgroup. Common side effects included headache, fatigue and myalgia. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in all subgroups.

Immunogenicity

Phase 1 results showed NVX-CoV2373 elicited robust antibody responses which were greater than the responses measured in people recovered from natural COVID-19 infection. All participants developed antibodies after a single dose. All participants developed neutralizing antibodies after the second dose. The Matrix-M1 adjuvant was dose sparing; in those receiving NVX-CoV2373 with the Matrix-M1 adjuvant, immunogenicity results were comparable in both low and high dose groups. The Matrix-M1 adjuvant also induced robust polyfunctional CD4+ T-cell responses.

Vaccine efficacy

Interim data regarding vaccine efficacy from the UK’s Phase 3 trials are expected in the first quarter of 2021, noting the high rates of COVID-19  being seen globally may lead to early completion of these event driven trials.

Resources

Authors: Daniela Say (MVEC Immunisation Fellow) and Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute)

Date: January 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.

 

 

 

 

 

 

 


No jab no pay

On July 1 2018 national legislation was introduced altering Family Tax Benefit (FTB) Part A payments and childcare subsidies if a child is not up to date for age with their scheduled immunisations as per the National Immunisation Program (NIP). Exceptions to this include being on an approved catch up schedule, having a valid medical contraindication or natural immunity recorded on the Australian Immunisation register (AIR). Recipients of FTB part A or child care fee assistance will need to meet these immunisation requirements to ensure that payments are not reduced.

Exemptions for conscientious reasons are no longer accepted. Only exemptions for medical contraindications and natural immunity will be approved and must be signed by an approved medical practitioner in order to be valid [see Resources].

Routine catch up vaccinations are free for all individuals aged less than 20 years (including those who do not hold a medicare card). Please refer to the resources below for eligibility criteria for funded catch-up immunisations. Catch up immunisations can be administered by local health care providers, council immunisation sessions, as well as hospital immunisation services. If your child is not fully immunised and you wish to receive family assistance payments, contact your health care provider to organise a vaccination catch-up program.

Resources

Author: Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)

Date: February 2019

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.


Needle phobia

Many people may find the experience of having a needle an unpleasant one. However for some people, the experience is much more difficult, presenting as a real phobia characterised by both severe and persistent anxiety and fear. As a result, this patient group often avoid needle-related experiences. This needle avoidance extends to the area of immunisation, resulting in the individual being left susceptible to vaccine-preventable diseases. This can result in further procedures involving needles should they become unwell.

Effective preparation, distraction techniques, pain management strategies and addressing the core reason for the phobia are all important steps in ensuring successful immunisation.

Below are some resources that can assist in the immunisation of needle phobic patients.

If immunisation attempts are unsuccessful you may consider referral to a specialist Immunisation clinic to discuss alternate options e.g. sedation.

Please contact SAEFVIC on 1300 882 924 (Option 1) for further discussion.

Resources

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

Date: February 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.


No jab no play

In an effort to improve vaccination rates and reduce the spread of vaccine preventable diseases, the Victorian state Government introduced the ‘No Jab, No Play’ legislation on the 1st of January 2016. This legislation requires confirmation of up to date vaccination status when enrolling in all early childhood education and care services including childcare and kindergarten. This legislation does not apply to enrolment into school.

On February 28 2018 this legislation was amended. Immunisation History statements provided by the Australian Immunisation Register (AIR) are now the only accepted proof of immunisation when enrolling in early childhood education and care services. Previous forms of documentation (e.g. GP letter or local council statement) will no longer suffice.

In order to be up to date on AIR, a child must have received all scheduled immunisations for their age according to the National Immunisation Program (NIP). Exceptions to this include being on an approved catch up schedule, having a valid medical contraindication or natural immunity recorded on AIR. Exemptions for conscientious reasons are no longer valid. Only exemptions for medical contraindications and natural immunity are accepted and must be signed by and approved medical practitioner in order to be valid.

More details on the legislation and documentation required are in the Resources section below.

Resources

Author: Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children's Research Institute)

Date: February 2019

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.


Neurologic and neurodevelopmental conditions

There are a number of neurological conditions that are associated with an increased risk of vaccine preventable diseases. These include:

  1. Epilepsy and seizure disorders
  2. Developmental delay and intellectual disability
  3. Cerebral palsy
  4. Neuromuscular disorders
  5. Hydrocephalus and children with ventricular-peritoneal shunts

Children with any of these underlying conditions should have routine vaccinations according to the Australian National Immunisation Program Schedule.

In children where epilepsy is unstable, or there is a progressive neurological disorder of unclear aetiology, specialist consultation is recommended to advise on the appropriate vaccination course. In Victoria, referrals for this service should be made to SAEFVIC.

Influenza vaccination

All children with neurologic and neurodevelopmental conditions are at high risk of severe and complicated influenza infection.

This includes disorders that do not have an obvious compromise in respiratory function such as intellectual disability and epilepsy. Influenza infection can also markedly increase seizures in children with epilepsy.

These children should all be offered annual influenza vaccination from 6 months of age. Two doses are required in the first year the vaccine is received if less than 9 years of age [see Resources].

Pneumococcal vaccination

Children with CSF leaks and intracranial shunts are at higher risk of invasive pneumococcal disease. This includes brain inflammation (meningitis) and blood infection (bacteraemia). These children should be offered additional vaccines, including an extra pneumococcal conjugate vaccine to optimise protection.  See the Pneumococcal chapter in the Australian Immunisation Handbook for the latest recommendations [see Resources]

Human Papillomavirus (HPV) Vaccination

Transmission of the HPV virus is primarily through sexual intercourse and can also occur via non- penetrative sexual contact.

There is some evidence for potential virus transmission via viral particles on hands.

HPV infection is associated with the potential development of serious disease such as cervical and anogenital cancers. The infection is also the primary cause of anogenital warts.

As transmission can be varied, children with neurodevelopmental conditions should be offered HPV vaccination as per the routine secondary school program.

Resources

Author: Teresa Lazzaro (Paediatrician, Immunisation Service, Royal Children's Hospital Melbourne)

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.