Published: 27 November 2020
Revised 11 October 2021

COVID-19

COVID-19 Therapeutic Products – Questions and Answers

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

Vaccine approval

When will a vaccine be approved?

See the approval status of COVID-19 vaccine applications received by Medsafe

Why does Medsafe need to approve a COVID-19 vaccine if it has been approved overseas?

It is important that Medsafe makes its own judgements on whether a medicine is suitable for the New Zealand population. For a COVID-19 vaccine, the control of the pandemic is very different in New Zealand compared to other countries. It is also vital that we understand the data on safety, quality and efficacy, and its limitations. This helps us with safety monitoring of vaccines once they are being used, as well as the regulation of post-approval changes to vaccines.

Medsafe is working with other medicines regulators on both the approval process and safety monitoring.

How will Medsafe assess the short and long-term efficacy and/or safety of a COVID-19 vaccine?

Medsafe will apply its usual assessment criteria for the evaluation of any COVID-19 vaccine submissions. We will use international regulatory guidance in general, and advice specific to COVID-19 vaccines.

Efficacy is determined by the results of clinical trial(s) and studies on the types of immune response generated by the vaccine.

Safety data will be available from the clinical trials. As for all medicines, additional safety information will be gathered from long-term follow-up of clinical trial participants and safety monitoring.

Quality will be evaluated by reviewing the data on formulation, manufacturing, purity and stability, as well as the controls used to ensure batch-to-batch consistency. The vaccines will need to comply with international requirements for laboratory testing and good manufacturing practice.

Most information provided to Medsafe as part of a medicine application is confidential to the pharmaceutical company. However, some detail such as the qualitative product formulation, site of manufacture, and the data sheet will be published on Medsafe website when the vaccine is approved.

Will Medsafe grant an Emergency Use Authorisation for a COVID-19 vaccine?

Medsafe does not have the ability to grant an Emergency Use Authorisation.

Regulators in other countries have the ability to grant Emergency Use Authorisations, which allow highly restricted use of a medicine in an emergency situation following a limited review of data to support safety and efficacy. The pandemic situation in other countries where this may be considered is very different to the situation in New Zealand.

More information about how Medsafe will evaluate applications for COVID-19 vaccines

What impact will COVID-19 vaccine applications have on Medsafe’s normal work?

In order to prioritise the evaluation of COVID-19 vaccine applications, Medsafe will need to reallocate work for some staff. Although this is likely to affect our regular work during this time, we aim to put in place additional staff to ensure that it does not have a long-term impact on our overall performance timelines.

What research has been undertaken and/or reviewed about COVID-19 vaccine effectiveness and risks, including from hyperimmune responses?

Any company wishing to seek consent for a vaccine in New Zealand must provide evidence to show the efficacy, quality and safety of the vaccine, including the risk of hyperimmune responses with COVID-19 vaccines.

How long will the vaccines work?

At this stage, we do not know how long a vaccine might work for. The efficacy of Comirnaty after 6 months of follow up, after dose 2 was 91% overall (see table 4 in the data sheet).

Will the vaccines still work if COVID-19 mutates?

Scientists and regulators will be monitoring whether mutations in the SARS-CoV-2 virus are likely to alter the effectiveness of any vaccines.

Do mRNA vaccines alter DNA?

No, mRNA vaccines contain RNA, which does not alter DNA. More information about how mRNA vaccines work

Where can I find the clinical, safety, and quality data that Medsafe evaluated to approve COVID-19 vaccines?

Information submitted to and held by Medsafe as part of the approval process is confidential to the respective pharmaceutical companies.

However, Medsafe will publish the following information for any COVID-19 vaccine that gets approved.

  • Data sheet published on behalf of the pharmaceutical company, this contains information for health care professionals about to the safe and effective use of the vaccine. The data sheet also includes details on special warnings and precautions for use, any known side effects such as adverse events, and information about the vaccine’s pharmacological properties.
    Search for a data sheet
  • Product details – this includes the name of the New Zealand sponsor, approval dates, vaccine composition, sites of manufacture and a summary of any indications for use.
    Search for product details

Some summary assessment information for vaccines authorised for emergency use by international regulators is publicly available. For example, the following information for the Pfizer/BioNTech COVID-19 vaccine (also known as Cominarty):

What are the conditions of provisional consent for COVID-19 vaccines?

The conditions of provisional consent for approved COVID-19 vaccines are described in the gazette notices available on the Status of Applications page. These conditions require the sponsor company to provide Medsafe additional information to support the ongoing quality, safety and efficacy of the vaccines and to conduct other activities within the timeframes specified.

Provisional consent allows conditions to be imposed on the vaccine, restricting its use by healthcare professionals according to the data available at the time of approval. Provisional consent was included in the Medicines Act to allow New Zealand patients to have early access to medicines with a significant unmet clinical need.

What happens when the provisional consent for a COVID-19 vaccine expires?

Provisional consent was granted to all three currently approved COVID-19 vaccines for a period of nine months. Prior to expiry of this period, provisional consent may be renewed for a further period of up to two years, full consent may be granted, or the consent may not be renewed.

The provisional consent for Comirnaty expires on 3 November 2021 and Medsafe has not yet confirmed how it will proceed beyond its current period. However, it is likely that it will be renewed for a further two years to allow for the continued application of appropriate conditions as additional quality, safety and efficacy data is received and reviewed.

It is not possible to indicate a timeline for the granting of full consent as this will depend on the submission of an application by the sponsor company Pfizer and the outcome of Medsafe’s assessment of any additional supporting data.

Will all promotional material state that the Comirnaty vaccine has provisional consent?

There is no requirement for promotional material to state that the vaccine has provisional consent. However, any form of advertising, including promotional material, must comply with the requirements in the Medicines Act 1981, Medicines Regulations 1984 and  Misuse of Drugs Regulations 1977

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Vaccine safety

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. See the Centre for Adverse Reactions Monitoring (CARM) website for more information.

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 Cominarty 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 12 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).

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Vaccine import

Can I import a COVID-19 vaccine and sell it in New Zealand?

No, this would be a breach of section 20 of the Medicines Act 1981.

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Medicines to treat COVID-19

Why has Medsafe not approved any new COVID-19 treatments for use in New Zealand?

For a medicine to be approved, the company that supplies it must apply to Medsafe and provide data to support the quality, safety and efficacy of the medicine. No application has been made to Medsafe for any new medicine indicated to treat COVID-19, such as remdesivir.

Are there any approved medicines that can be used to treat COVID-19?

Yes. Dexmethsone 0.5 mg tablets (Aspen Pharmacare Australia Pty Ltd) are approved for treating COVID-19. The data sheet for this medicine is available on our website: Dexmethsone data sheet (PDF, 257 KB, 10 pages).

Can hydroxychloroquine or ivermectin be used to treat COVID-19?

Medsafe has not received any applications for approval of these medicines for treatment of COVID-19. Refer to the medicine’s data sheet for the approved indications.

See the following links for more information on ivermectin and COVID-19:

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