Published: 27 November 2020
Revised 22 November 2021
Archived: 21 August 2024

About Medsafe

COVID-19 Archive

COVID-19 Vaccine Safety – Questions and Answers

This page provides some commonly asked questions about Medsafe’s regulatory role in monitoring the safety of vaccines used for the COVID-19 pandemic. More information about COVID-19 is available on the Ministry of Health website.

Should I be getting a COVID-19 vaccine while I am pregnant?

Currently, the Comirnaty (Pfizer) vaccine is the only COVID-19 vaccine available in New Zealand. There is limited data with the use of Comirnaty in pregnant women. Animal studies have not indicated direct or indirect harmful effects in pregnancy, development of the fetus or the newborn. Please refer to the Comirnaty data sheet and Consumer Medicine Information (CMI) for more information.

The United States Centers for Disease Control and Prevention (CDC) is currently enrolling eligible participants and analysing the data to better understand how COVID-19 vaccination affects pregnant women. They have published some preliminary data. See the CDC website for more information.

If you are pregnant, please talk to your healthcare professional before getting the COVID-19 vaccine. Your healthcare professional can discuss with you the benefits and risks of getting the COVID-19 vaccine in your particular circumstances.

Real world evidence to date suggests that the benefits are likely to outweigh the risks. See the following websites for more information around the use of the COVID-19 vaccines in pregnancy and breastfeeding:

What adverse effects (or events) after vaccination are doctors, nurses, DHB staff, pharmacists required to report to the Centre for Adverse Reactions Monitoring (CARM)?

There is no legal requirement for healthcare professionals to report adverse events following immunisation (AEFIs). However, we encourage healthcare professionals to report all AEFIs. Consumers can also report any reactions they experience to medicines and vaccines.

Report an adverse event

Are adverse events occurring within a specified period after vaccination required to be reported to CARM?

There is no time limit for reporting adverse events.

Are adverse events listed by the vaccine manufacturer in the package inserts and data sheets required to be reported to CARM?

There is no legal requirement to report adverse events. However, we encourage reporting of adverse events listed in the package inserts as well as any event that may be related to vaccination.

More information about reporting

If a patient has previously had an adverse event to a vaccine, can they receive a COVID-19 vaccine?

Healthcare professionals should refer to the data sheet for information on contraindications to specific vaccines. These are published on our website.

Search for a data sheet

In addition, the Medical Warning System is used to record any serious events to previous vaccinations which may need to be considered for future vaccinations. More information about the medical warning system.

The Immunisation Advisory Centre (IMAC) is providing healthcare professionals with clinical support to help determine if it is safe to give a second dose of COVID-19 vaccine to individuals experiencing significant adverse events after the first dose.

Are healthcare providers required or strongly encouraged to report all recognised adverse events or new onset heath conditions that occur after the administration of a vaccine, whether or not it is clear that a vaccine caused the adverse event?

We encourage reporting of any suspected reaction/event to any vaccine, regardless of whether it is serious, minor, well-established, or of uncertain causality.

Adverse reactions should be reported even if it is not certain that the vaccine has caused it.

Report an adverse event.

Are vaccine manufacturers/sponsors required to report to CARM all adverse events occurring in New Zealand that come to their attention?

A detailed explanation of vaccine manufacturer/sponsor responsibilities for adverse event reporting is available on our website: Guideline on the Regulation of Therapeutic Products in New Zealand, Part 8: Pharmacovigilance (PDF, 424 KB, 35 pages).

Does the vaccine affect fertility?

Animal studies for the Comirnaty vaccine did not show any effect on fertility.

Who is liable for adverse events following a vaccine?

ACC can provide treatment and support for injuries caused by COVID-19 vaccination if the criteria for treatment injury are met. This means there is a physical injury caused by the vaccination, that is not a necessary part or ordinary consequence of the treatment.

See the ACC website for more information.

Are the vaccines dangerous for people with previous COVID-19 infection?

The Comirnaty clinical trials included people with previous COVID-19 infection. There are no known safety issues for people with previous infection.

Are the vaccines safe for children?

The Comirnaty vaccine is indicated for use in individuals aged 5 years and older. Clinical trials to assess safety and efficacy in children are ongoing.

For people with allergies, what information is available about vaccine ingredients?

Refer to the vaccine’s Data Sheet or Consumer Medicine Information (CMI) for the list of ingredients.

Are the vaccines safe for people with immunodeficiency or autoimmune conditions?

Refer to the vaccine’s Data Sheet or Consumer Medicine Information (CMI). The Australasian Society of Clinical Immunology and Allergy (ASCIA) has published a position statement which includes information about COVID-19 vaccines, immunodeficiency and autoimmune conditions.

See the ASCIA position statement

What studies have Medsafe done to ensure the vaccine is safe for general use?

Medsafe does not conduct studies. Medsafe reviews the data submitted by the pharmaceutical company, including clinical trial data. See above for more information on the types of data that is required.

What is an acceptable number of side effects?

We encourage healthcare professionals and consumers to report any suspected side effect to a COVID-19 vaccine. For this reason, and because so many people will be receiving a vaccine, we expect many side effects to be reported. Reports describing significant events are reviewed by medicine safety experts to identify any previously unrecognised adverse drug reactions or changes in the patterns of adverse drug reactions.

Receiving large numbers of reports also indicates that the reporting system is working and easy to use.

More information about the vaccine safety monitoring process

What is the follow-up process for reports of significant adverse events with the COVID-19 vaccines, including fatal reports?

The Centre for Adverse Reactions Monitoring (CARM) and Medsafe investigate reports of significant events, including those with a fatal outcome. In the first stage of the process, the report is verified to check that there is an identifiable individual who has had a COVID-19 vaccination and the reporter can be contacted. Any report that doesn’t meet these criteria is invalid and is not further investigated.

Sometimes the initial report doesn’t contain enough information for assessment so CARM or Medsafe will seek further information from the reporter. For any report, the reporter may be the person who experienced the event, their friend or relative, or the GP or other healthcare professional who treated them. Regardless of who reported the significant event, the relevant healthcare professionals will be contacted for more information. If the person died and their GP or doctor reported the death to the coroner, CARM will also contact the coroner or the pathologist.

The investigation process can take some time and may not always be successful if there is no response to requests for information or there is no further information to share.

The aim of the investigation is for CARM and Medsafe to determine the likelihood that the vaccine caused the reported events. For significant cases, including deaths, the COVID-19 Independent Safety Monitoring Board (CV-ISMB) review the information obtained during the investigation and provide their view on the likely relationship of the reported events to vaccination.

Note that the cause of death is investigated and determined by the coroner, not by CARM or Medsafe. See the Coronial Services website for more information about the coronial process.

For background information about the investigation process, see the World Health Organization’s COVID-19 Vaccines: Safety Surveillance Manual (see the ‘AEFIs’ and ‘AESIs’ annexes).

A study has been launched to find out if people who developed myocarditis or pericarditis following COVID-19 Pfizer vaccination had long-term health problems. This study is a collaborative effort across the Ministry of Health, Medsafe and CARM. Find out more, including who can take part in the study.

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What is Thrombosis with Thrombocytopenia Syndrome (TTS)?

Thrombosis with Thrombocytopenia Syndrome (TTS) is a very rare side effect of the AstraZeneca (Vaxzevria) and Janssen COVID-19 vaccines. Pfizer (Comirnaty) vaccine has not been associated with TTS. Medsafe has developed information about TTS for consumers and health care professionals:

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