COVID-19: Vaccine safety and approval

Medsafe are doing robust assessments of COVID-19 vaccines so that we can be confident they’re safe and effective before they can be used in New Zealand.

Last updated: 19 February 2021

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Making sure the vaccines are safe

Our priority is to make sure we have access to safe and effective COVID-19 vaccines.

Medsafe is New Zealand’s own medicines safety authority. They robustly assess all vaccines to ensure they meet international standards and local requirements for quality and safety.

No vaccine will be made available for public use in New Zealand until Medsafe complete their assessment and it’s been approved.

Medsafe – Vaccine safety monitoring process


Provisional approval of vaccines

Provisional consent means the pharmaceutical company must meet certain conditions, including supplying more data from its clinical trials around the world. This will happen at the same time as the vaccine is rolled out.

Medsafe provisionally approve the first COVID-19 vaccine

Medsafe have provisionally approved the first vaccine for COVID-19 in New Zealand. Dr Ashley Bloomfield and MedSafe Group Manager Chris James explain how that process works.

[Dr Ashley Bloomfield] Kia ora koutou katoa, I'm Dr Ashley Bloomfield, Director-General of Health and I've got with me today Chris James who's the Group Manager at Medsafe. Medsafe's our independent medicines regulator here in New Zealand and it's just completed the work with its advisory committee on looking at the very first vaccine against COVID-19 that we will be able to deploy in New Zealand. You may have heard the announcement by the Prime Minister just this afternoon - exciting news!

And this does mean that all the planning we have been doing over the last few months and the hard work that Medsafe has been doing to look at all the information all the data from clinical trials that's out there to provide us with advice on whether or not we should use this first vaccine that's available for New Zealand, the Pfizer vaccine.

What I should say before I throw a few questions Chris's way is that we still are in the middle of this global pandemic and in many senses even as we roll out this vaccine and other ones that we hope will be available for us when they're approved, our elimination strategy is still absolutely the way that New Zealand is dealing with this virus.

So our borders remain very tightly managed with  managed isolation and quarantine. Anyone coming into the country will need to spend 14 days there.

For all of us already in New Zealand, all those things we have been doing and need to continue to do remain the same during 2021: We need to keep washing our hands, not going out if we're unwell and of course using the NZ COVID Tracer app to scan wherever we go and make sure Bluetooth is on.

But this is an exciting day we have got approval for the first of these COVID-19 vaccines, the Pfizer vaccine, and so I'm going to talk with Chris a little bit about the process Medsafe uses to reassure us - all of us - as Kiwis, how we know that this vaccine and others that come after it are absolutely safe and effective and that they're  at the right thing for us to use here in New Zealand. So Chris, welcome to this discussion, and I just want to wonder if you could start first with, just talk a little bit about the process that Medsafe uses to approve a vaccine.

[Chris James] Absolutely, so what we have done, we've been working with the companies for a number of months now and one of the things we've done is allowed them to, for instance, provide us data on a rolling basis as they generate it, which is very helpful.

This has helped us to streamline our process but make sure it is absolutely rigorous in terms of our review, in terms of the requirements that we need to see met before we approve a vaccine. There are three key main parts that we look a. The first is efficacy, so how effective is the vaccine? And this is generated from clinical trials. We get that data through and my assessors look at that and look to see you know how effective is the vaccine the second one is clearly important and that's about safety.

And again that comes from clinical studies.

We've also been quite fortunate in New Zealand, that we've been able to learn off other countries, who have administered millions of doses to their populations and we're in really close contact with them to get the reports that they've been receiving and get a really good sense of safety information and what adverse reactions or side effects might be coming through.

And the last part is quite important as well and that's about manufacturing data. The company has to provide us a lot of information to show they can make a really high quality product, that each batch is consistent and that's very important because obviously we want the vaccine that comes into New Zealand to be really high quality.

- Yeah. - So once we've assessed that we also go off and get expert advice and we can get expert advice from our the medicines assessment advisory committee, which we did yesterday, who supported our proposal to grant an approval with conditions on the Pfizer vaccine.

[Dr Ashley Bloomfield] Yeah thanks Chris, that's a nice description of the sort of things you're  considering and you've talked about the sort of advantage New Zealand has got in being able to get the data from the experience of other countries, and you know, what what is, what are those data showing us already around safety and even effectiveness of this vaccine in practice?

[Chris James] So you're right, you know, we're getting a lot of information coming through and you know we've seen clinical studies that include at least 20,000 people that are that are ongoing  and we and we continue to get updates from the company on those, which is really helpful.

And the information we've seen coming through from regulators that we're in regular contact with, you know, on a weekly basis, what we're seeing is predominantly the side effects being reported are mild and tend to resolve over a couple of days.

They include things like soreness, you know,  soreness in your arm, perhaps a bit of redness where the weather vaccine was was administered.;

People have reported headaches, for instance, they may have a headache, may feel a bit lethargic,  but these have all - what we've seen in the clinical studies has been confirmed  in the information we're seeing coming from other countries, that these tend to be mild  and and resolve over a couple of days.

[Dr Ashley Bloomfield] And these are often the sort of side effects people will  have if they have, for example, a flu injection every, flu vaccination every year, you can - the  arm can feel a bit sore, maybe a little bit tender for a few days afterwards.

Some people even feel  a little bit unwell, but actually that's the body mounting a sort of immune response to the vaccine isn't it?

[Chris James] That's exactly right, that's exactly right, these are common reactions with  with vaccines, including the flu vaccine which which a lot of people will be familiar with& and what's really reassuring for us is that the information we've had from other countries has not not shown up any surprises in terms of side effects being reported.

[Dr Ashley Bloomfield] Thanks very much  Chris we know from our surveys and indeed the conversations I've been having with people that Kiwis want to know that any vaccine we use here in New Zealand is safe and effective and I think Chris has just nicely outlined how we can be confident that Medsafe has gone through a meticulous process, they haven't cut any corners, and that they will be keeping a close watch on developments internationally even as we now start the process of getting these vaccines onshore and rolling them out to the population.

Thanks again, Chris. - Thanks very much.


How the vaccines were created so fast

There’s never been this level of global collaboration amongst scientists and governments in vaccine development. This has improved the speed of its development and the launch of clinical trials around the world.

Large manufacturing plants have been developed, so vaccines can be produced faster and on a larger scale than what was possible.

We’re moving swiftly but without taking any short cuts or compromising safety.

Sharing data internationally

Vaccine companies have been sharing their data all over the world, which has sped up the research process and led to several innovations. This includes the use of the messenger RNA technology.

We continue to receive data from large, ongoing clinical trials. This means:

  • we can monitor the safety and effectiveness of the vaccines right through the initial roll-out and into their ongoing use
  • Medsafe can start assessing the clinical trial data much sooner than they normally would.

All these changes mean that safety approvals that used to take a long time have happened faster.


Side effects from the vaccines

Like all medicines, the vaccine may cause side-effects in some people. These are common and mostly mild. This is a sign of the body’s response to the vaccine and shows that it’s working.

Pfizer and BioNTech (Comirnaty) vaccine

See the common side effects for the Comirnaty vaccine

Reporting side effects after vaccinations

We’ll be using Centre for Adverse Reactions Monitoring (CARM) for both health professionals and patients to report any vaccine side effects online. We’re in the process of working with CARM to extend this tool to ensure it can manage the needs for COVID-19 vaccine reporting.

About CARM


Effectiveness of the vaccines

No vaccine is 100% effective. There’s no evidence yet that the vaccine will stop transmission, but it will help protect you against COVID-19.

Vaccines are just one part of our strategy to keep COVID-19 out of New Zealand. We need to keep washing our hands, staying home if we're unwell and using the COVID Tracer App or keeping a record of where we’ve been.

New strains of the virus

We’re evaluating preliminary data from other countries about the impact new strains may have on vaccine effectiveness.

Some companies have indicated they may make changes to the vaccine to make sure they work properly. This is similar to the regular changes made to the influenza vaccine.


Streamlining the approval process

Medsafe has streamlined its approval processes and are prioritising the evaluation of COVID-19 vaccines for faster access. They’ll still have the same rigorous level of scrutiny that all medicines undergo.

This includes allowing pharmaceutical companies to submit rolling applications for approval for their vaccines, rather than submitting all their data at once.

Medsafe is actively assessing the best approach for New Zealand and considering community outbreaks as it works through the approval process.

Medsafe – COVID-19 Vaccine evaluation and approval process

Sharing data internationally

Medsafe is sharing information and guidance on our data requirements for approving COVID-19 vaccines with regulators internationally. This includes the level of clinical trials and manufacturing data needed to demonstrate efficacy and safety.

This process has been operating for over 15 years and reduces the time taken to assess new medicines in New Zealand without compromising our standards.


If the vaccines contain new organisms

If any of the COVID-19 vaccines arriving into New Zealand contain a new organism, the Environmental Protection Authority (EPA) will be involved. They’ll need to approve the import, development and field testing or release under the Hazardous Substances and New Organisms Act 1996 (HSNO Act).

EPA have a rapid approval pathway for any vaccines that are, or contain, new organisms which includes genetically modified organisms. They can look at applications at pace where needed and are working with Medsafe and Ministry for Primary Industries (MPI) in preparation for the vaccines.

Environmental Protection Agency – New organisms

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