Published: 27 November 2020
Revised 28 October 2021

COVID-19

COVID-19 Vaccine Approval – Questions and Answers

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

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):

• United Kingdom – Summary of the MHRA’s public assessment report for the Pfizer/BioNTech COVID-19 vaccine
• European Union – Summary of the European public assessment report for 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.

Medsafe has renewed the provisional consent for Comirnaty for a period of two years and the renewed consent is valid until 3 November 2023. More information is available on the Status of Applications page.

A sponsor company may submit an application for full approval at any time while a provisional consent is valid. However, it is not possible to indicate a timeline for the granting of full consent for any of the approved COVID-19 vaccines as this will depend on the submission of an application by the sponsor 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

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.