Published: 27 November 2020

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

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.

When will a COVID-19 vaccine be approved?

We are unable to say if or when a vaccine will be approved. There will be no approval of a vaccine in 2020 as companies have indicated that the full data set will not be provided by the end of 2020.

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.

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.

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 – 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):

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Vaccine safety

What, if any 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 after 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 another 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.

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).

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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).

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