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Nuvaxovid, the Novavax COVID-19 vaccine is a recombinant protein vaccine that has been approved to be used as a primary vaccination course from 12 years of age and as a first booster or additional booster dose for people aged 18 years and older in Aotearoa New Zealand.
Use as an additional booster dose is limited by the criteria for additional boosters.
Comirnaty 30mcg and 15/15mcg grey cap vaccines continue to be the preferred vaccine.
Using recombinant DNA technology, the genetic material coding for the SARS-CoV-2 spike protein is inserted into the genetic code of an insect baculovirus. Modified cells are grown to produce large quantities of the spike protein, which is then isolated and purified ready for use in the vaccine. No insect cells or baculovirus remain in the vaccine.
The recombinant spike protein, together with the adjuvant, Matrix-M, form immunogenic nanoparticles that mimic the SARS-CoV-2 virus, stimulate antigen-presenting cells, and generate long-lasting protective cellular and humoral immune responses.
The stopper is synthetic rubber. No latex is present in the vaccine vial lid or cap.
Injection site pain or tenderness; tiredness; headache; muscle or joint pain; generally feeling unwell.
Rare side effects include severe allergic reaction (eg, anaphylaxis)
Also available for adolescents and adults aged from 12 years is the messenger RNA vaccine, Comirnaty 30mcg and 15/15mcg grey cap vaccines.
Vaxzevria (AstraZeneca) and COVID-19 vaccine Janssen are also licensed but are not currently available in NZ.
Nuvaxovid is used as a primary course, for those over 12 years of age with 2 doses, given at least 3 weeks apart, ideally 8 weeks apart.
When used as part of a primary series, ie, after a first dose of Comirnaty, a prescription and written consent is required.
People who have a medical condition or are receiving therapies that affect the function of their immune system are at increased risk from severe COVID-19 illness. Vaccination is highly recommended but depending on the type and the level of immunocompromise they may not produce as good a protective response as a healthy person. This means that they are less well protected by the vaccine or their protection wanes to below protective levels faster. Extra doses of COVID-19 vaccine can help to overcome this reduced response.
Information for vaccination of severely immunocompromised people is here.
If an alternative to Comirnaty is required or requested, Nuvaxovid can be given as a third primary dose to those aged 18 years or older with a prescription and written consent. For further detail see the Immunisation Handbook 2020 Chapter 5 (section 5.5.8).
First booster doses are available for those 18 years of age from 6 months after previous COVID-19 vaccination or infection.
Additional booster doses are available to those 6 months after a previous COVID-19 vaccination or infection who are:
· Aged 30 years and over.
· Aged 18 years and over who meet the eligibility criteria.
Additional booster doses should be administered from 6 months after the previous dose of COVID-19 vaccine, and/or from 6 months after a COVID-19 infection, with flexibility for the dose to be given from 3 months after a COVID-19 infection.
When used as a first booster or additional booster dose, a prescription is not required even if the previous doses were with different COVID-19 vaccines.
For details on storage and preparation of the Nuvaxovid vaccine please refer to the most current advice in our vaccine preparation resources. Click here for more information on cold chain processes.
· Each multi-dose clear glass vial contains 10 doses of 0.5ml. The vial has a blue plastic cap.
· The vaccine does NOT require dilution and must NOT be shaken at any stage.
· Nuvaxovid does not need to come to room temperature before administering.
Nuvaxovid is stable in vial for 12 hours from opening (6 hours in a syringe) at +2°C to +25°C. (Note: this is a lower room temperature than Comirnaty vaccines). It is best practice to return vials to cold chain, making sure they are appropriately labelled with their expiry date and time.
Comirnaty is the first line COVID-19 vaccine to have in pregnancy, however, Nuvaxovid is available for those preferring an alternative option. An informed consent discussion outlining the potential risk versus benefit for its use is important prior to vaccination. Written consent and a prescription are required.
There is limited data to date around the use of Nuvaxovid in lactating women. Although, as with all National Immunisation Schedule vaccines, there are no concerns about giving vaccines to individuals who are lactating, the safety of Matrix M adjuvant has not yet been evaluated in human breastmilk. Prior to administration, breastfeeding women are encouraged to discuss benefit and risk with their health professional.
Nuvaxovid may be administered before, after, or at the same time as other NIS vaccines.
When using other adjuvanted vaccines - namely Shingrix and Fluad Quad - consumers should be informed of the possibility of a stronger post-vaccination response when two or more of these are administered together.
Common side effects after Nuvaxovid include injection site pain or tenderness; tiredness; headache; muscle or joint pain; generally feeling unwell. Most side effects are mild and go away within a few days.
Rare side effects include severe allergic reaction (eg, anaphylaxis). The vaccine has had limited take up around the world so information on rare side effects is limited.
Cases of myocarditis and pericarditis were identified in clinical trials of Nuvaxovid and have also been reported during post-authorisation use. Australian Therapeutics Good Administration monitoring has received reports of myocarditis in around 3-4 in every 100,000 doses of Nuvaxovid. Pericarditis is reported in 13 in every 100,000 doses but is more common in men aged 18-49 years (estimated at 27 per 100,000 doses). Post marketing experience also includes reports of numbness or painful skin sensations.
To date in Australia there have only been about 2,300 Nuvaxovid doses administered in people aged 12-17 years and no adverse events following immunisation have been reported.
Nuvaxovid is contraindicated for individuals with a history of anaphylaxis to a previous dose of this vaccine or to any component of the vaccine, including polysorbate 80, saponin, monobasic sodium phosphate or monohydrate. See Medsafe Nuvaxovid data sheet for full details.
The Nuvaxovid vaccine is being held to the same high safety standards as all vaccines and medications licensed for use in New Zealand. CARM monitors and analyses the database for the identification of new signals, or important patterns, clusters or unusual events or practices that could have significance for medicine safety and prescribing practices in New Zealand. Any adverse event experienced post vaccination should be reported to CARM. Click here for more information on adverse events following immunisation, reporting and monitoring.
Early data supports the safety and effectiveness of Nuvaxovid when being used as a booster dose.
The immune responses were enhanced when a booster dose was given approximately six months after the two-dose primary course, as shown in a phase II clinical trial assessing the immunogenicity. For both Delta and Omicron, immune responses following the booster were notably higher than those associated with high levels of efficacy in phase III studies of the vaccine.
In the UK, COV-BOOST study participants aged 30 years or over with no history of laboratory-confirmed SARS-CoV-2 infection were given one of six vaccines as a booster dose at least 84 days post two doses of Comirnaty or at least 70 days post two doses of AstraZeneca. Following a Comirnaty primary series, the neutralising antibody titre after a dose of Nuvaxovid was 2.7–5.4 greater than the control, while a Comirnaty booster induced 5.8–8.4 higher antibody titres.
For those who experience severe adverse events to their second dose of Comirnaty vaccine, Nuvaxovid would be an effective booster although it appears less immunogenic than Comirnaty as a booster dose.
Laboratory tests suggest that Nuvaxovid has efficacy against the Omicron strain, but real-world data from people vaccinated with Nuvaxovid is not available yet.
Mallory R, Formica N, Pfeiffer S, et al. Immunogenicity and safety following a homologous booster dose of a SARSCoV-2recombinant spike protein vaccine (NVX-CoV2373): A phase 2 randomized placebo-controlled trial. med Rxiv, 2021(preprint): p. 2021.12.23.21267374.
Munro APS, Janani L, Cornelius V, et al. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster)following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multi centre, randomised, controlled, phase 2 trial. Lancet, 2021. 398(10318):p. 2258-2276.
