Covid19

COVID-19: Vaccines | Ministry of Health NZ

Read more at www.health.govt.nz

[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 ofthis 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.

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