Safety Information

Alert Communication

Myocarditis and pericarditis have been reported with Nuvaxovid (Novavax COVID-19 Vaccine)

8 September 2022

There have been a small number of cases of myocarditis and pericarditis reported internationally following vaccination with Nuvaxovid. The medicine sponsor now considers that myocarditis and pericarditis may be rare side effects of Nuvaxovid.

Healthcare professionals and vaccinators must inform people being vaccinated with Nuvaxovid about myocarditis and pericarditis and advise them to seek urgent medical attention if they experience symptoms.

The following warning will be added to the Nuvaxovid data sheet shortly:

Myocarditis and pericarditis have been reported in male and female adults within 14 days of Nuvaxovid administration.

Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.

Available data cannot determine a causal association with Nuvaxovid.

Vaccinated individuals, parents and caregivers should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination.

The risk of myocarditis and pericarditis after a third dose of Nuvaxovid has not yet been characterized.

Myocarditis and pericarditis can also occur with COVID-19 disease.

The benefits of vaccination with Nuvaxovid continue to outweigh the risk of experiencing a side effect for people of all ages in the approved indication.

Advice for Consumers and caregivers
Information for vaccinators
Information for healthcare professionals
Products affected
Further information
Useful links

Advice for Consumers and caregivers

Myocarditis and pericarditis are treatable. Outcomes are better the sooner you start treatment.
In the first couple of weeks after your vaccination, seek urgent medical attention if you experience:
- new-onset chest pain (or an increase in severity of existing chest pain), discomfort or heaviness
- shortness of breath or difficulty breathing
- an abnormal heartbeat or a racing fluttering feeling or a feeling of skipped heartbeats
- dizziness, feeling lightheaded or fainting may also occur with the symptoms above.
These are potential symptoms of myocarditis and pericarditis.
If you have an adolescent aged 12 years or older, please watch them for any decreased activity and actively question them about any symptoms. Children and adolescents may not realise they have symptoms or may not talk about them without being asked.
Nuvaxovid COVID-19 vaccine is highly effective in protecting people from COVID-19 infection, which can also cause myocarditis and pericarditis.
If you think you or a member of your family has had a reaction to vaccination, please talk to your doctor. You can also Report any adverse events following immunisation with COVID-19 vaccines to the Centre for Adverse Reactions Monitoring (CARM).

Information for vaccinators

Myocarditis and pericarditis are rare adverse reactions to vaccination with Nuvaxovid COVID-19 vaccine.
Myocarditis and pericarditis are treatable, and recovery is better the sooner treatment starts.
You must tell everyone being vaccinated with Nuvaxovid about the symptoms of myocarditis and pericarditis. Advise them to seek urgent medical attention if they experience any of the symptoms listed below.
Give the vaccinated person up-to-date written information to take home, for example the Nuvaxovid Consumer Medicine Information (which will be updated shortly), as this also gives them information on myocarditis and pericarditis. Provide this information even if they have received it previously.
Advise parents and caregivers to watch their children aged 12 years or older for any decreased activity and actively question their children about any symptoms. Children may not realise they have symptoms or may not tell someone that they feel unwell.
Te Whatu Ora and the Immunisation Advisory Centre will update educational materials in line with this advice.

Information for healthcare professionals

The sponsor has determined that myocarditis and pericarditis are potential rare side effects following vaccination with Nuvaxovid. Be alert to the signs and symptoms of myocarditis and pericarditis occurring in people after vaccination. This information will be added to the Nuvaxovid data sheet shortly.
Tell vaccinated individuals to seek urgent medical attention should they experience:
- new-onset chest pain (or an increase in severity of existing chest pain), discomfort or heaviness
- shortness of breath or difficulty breathing
- an abnormal heartbeat or a racing fluttering feeling or a feeling of skipped heartbeats
- dizziness, feeling lightheaded or fainting with the symptoms above.
Symptoms most commonly start in the first couple of weeks after vaccination.
Myocarditis and pericarditis are treatable, and outcomes are better the sooner that treatment is initiated.
Myocarditis associated with vaccination should be treated as per other causes of myocarditis. Consult applicable guidance and/or secondary care (eg, cardiology or general medicine) if needed for more information on management. Advice on management of myocarditis and pericarditis after mRNA COVID-19 vaccines has also been published in association with the Cardiac Society of Australia and New Zealand.
For advice on whether a subsequent dose of Nuvaxovid (eg, booster doses) is appropriate for a patient under your care please contact the Immunisation Advisory Centre (IMAC).
Please continue to report adverse events following immunisation with COVID-19 vaccines to CARM.

Products affected

Product name	Sponsor
Nuvaxovid	Biocelect New Zealand Ltd

Further information

Nuvaxovid is a protein vaccine used to prevent COVID-19 disease in people aged 12 years and older.

Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the tissue forming a sac around the heart. Myopericarditis means that both the heart muscle and the sac are inflamed.

There are many possible causes of myocarditis, the most common being viral infection. The Global Vaccine Data Network has published background rates for myocarditis and pericarditis in New Zealand.

There are insufficient reports in New Zealand to confirm a link between Nuvaxovid and myocarditis or pericarditis. Therefore, this communication is being issued on the basis of international reports and the conclusion of the medicine sponsor that there may be a causal link between Nuvaxovid and myocarditis and pericarditis.