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Medsafe provisionally approves Pfizer/BioNTech vaccine to be used in New Zealand once it arrives

Medsafe provisionally approves Pfizer/BioNTech vaccine to be used in New Zealand once it arrives
Image sourced from Wikimedia Commons

Medsafe has provisionally approved the Pfizer/BioNTech vaccine to be used in New Zealand once it arrives in the country.

Provisional approval means the pharmaceutical company must meet certain conditions as the vaccine is being rolled out.

Fifty-two of the conditions Medsafe put on the approval relate to requiring additional manufacturing data from the company, for instance as it upscales its manufacturing.

A further six conditions relate to additional clinical information, such as regular updates from clinical trials, and ensuring it receives any information on safety concerns from around the world.

Provisional approval is not uncommon. The annual influenza vaccine is given provisional approval.

Director-General of Health Ashley Bloomfield said, “Medsafe began assessing the clinical data provided by Pfizer/BioNTech in November, working over weekends and through the Christmas break.

“The data was provided on a rolling basis, which streamlined the assessment process and enabled a timely approval without compromising the rigour of the review of the vaccine.

“I want to reinforce that this has been a carefully considered decision every step of the way. It’s only been made after following the vigorous assessment processes which are an integral part of all New Zealand’s decision-making around medicines.”

Medsafe’s provisional approval doesn’t change the timeline around when vaccinations will begin.

The Government expects the first batch of the vaccine to arrive in New Zealand by the end of March.

“But we are making sure everything is in place in case there is an earlier arrival,” COVID-19 Response Minister Chris Hipkins said.

Two to three weeks will then be spent vaccinating border workers and the people they live with.

“People such as cleaners, the nurses who undertake health checks in MIQ, security staff, customs and border officials, airline staff and hotel workers will be among the first to get the vaccine,” Prime Minister Jacinda Ardern said.

The broader community will start accessing the vaccine from the “second half of the year”.

Providing more information on the decision, Medsafe Group Manager Chris James said, “Medsafe needed to be assured the vaccine would be safe and effective for use in a New Zealand setting, and that it was of a high quality.

“There are three key aspects assessed: the effectiveness of the vaccine, the safety data (both determined by clinical study results), and finally manufacturing data.

“All the data is considered and we then complete a benefit risk assessment, which allows us to balance the benefits of the vaccine against any known risks such as side effects. We have determined there may be some minor side effects such as a painful arm and headaches – these are not uncommon in other vaccines.

“We have also wanted to ensure the company can manufacture the vaccine to a high quality, and that all batches are consistent.

“Medsafe’s assessment went to the Medicines Assessment Advisory Committee (MAAC) yesterday (2.2.21) for its review, so the committee could provide Medsafe with advice and recommendations. The MAAC is made up of a range of industry experts from around New Zealand, and it met for six hours to help Medsafe come to a decision.”

National's COVID-Response spokesperson Chris Bishop tweeted a few questions for the Government: "Why are we not front of the queue like government said? What does contract say about delivery? When does it get here?"

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39 Comments

11
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"Front of the queue"

.

You really want to be front of the queue, when if we are, it will mean more people were dead overseas to protect us (when we are all ready being protected via border controls and excellent tracing)?

The vaccination program will be a major test of this governments capabilities...

Well they have a good chance here, with the BioNTech/Pfizer vaccine, to show that their program works at scale. Most other countries had to learn the hard way so we are lucky.

I do hope I get the BioNTech/Pfizer one and not the Johnson&Johnson ("Jansen") one.

Pfizer 95% v Jansen 66% efficacy I would prefer it to. What surprised me was Sputnik coming in at 92% .

https://www.bbc.com/news/health-55900622

Butter for Sputnik maybe?

Johnson&Johnsons "Janssen" vaccine is clearly a pup. Even the first shot of first shot of the OxfordUniversity/AstraZeneca is actually more effective (76%) as it turns out. There's no reason to choose that one over any of the many better options:
https://www.bbc.com/news/uk-55913913

We probably won't get our money back, no doubt we can send it onwards, but it's time to move forwards with other options.

My concern is they will stuff it up due to the lack of practical nous. A nationwide rollout requires a big management effort and I simply don't believe the govt and health team are up to the task. Over to them to prove me wrong...

They are already diverting the story towards the anti-vaxers as cover.

Well they'll get a trial run at scale vaccinations with this first round of the BioNTech/Pfizer vaccine.

True, and some mistakes are understandable, but we shall see if they learn anything.

learnt anything from the measles outbreak?

'Out break scare' - nek minute vaccine approved - with all stringent testing done - Dr Bloomfield verifies. Timing a coincidence or?

"with all stringent testing done" ? yeah nah. According to clinical trial NCT04368728 on clinicaltrials.gov we should have that safety and efficacy data by 31st January 2023.

Pseudo-scientific veneer, tick. Same old line, tick. At least we know it's you.

Congratulations, you found a clinical trial which hasn't completed yet. As if they're doing a single trial. What's your point exactly?

The clinical trial I mentioned is the premier highest quality clinical trial in relation to this vaccine. It's a large randomised placebo controlled double blind trial, and is sponsored by Pfizer and BioNTech.

not gonna use Pfizer/BioNTech vaccine for obvious reasons -- it killed people.

https://www.globaltimes.cn/page/202102/1214761.shtml
https://www.bmj.com/content/372/bmj.n149

Prove it. The WHO concluded no unexpected deaths.

https://www.who.int/news/item/22-01-2021-gacvs-review-deaths-pfizer-bion...

It's an occupational hazard when delivering a drug to 80-90 year olds, some of them will die for completely unrelated reasons. The important thing is - did a similar number die in the same period of time before the vaccine was delivered?

edit:
You've added links now - thanks. Still nothing proving anything, and confirming that the only deaths have been seen in very elderly, frail patients. This is a population with a ~20-30% chance of dying if they catch covid - do you advise these people to wait it out and take their chances with the disease rather than taking a 23/20,000 = 0.1% chance with the vaccine? This 0.1% is almost certainly a dramatic overestimate of the risk, even to the elderly, as deaths from other causes have not been removed.

Excellent, more vaccine for the rest of us.

You use Global Times as the reference, especially on COVID vaccines?

Hmmm – a lot of political theatre over approving something that may or may not arrive here in a couple of months’ time.

Did the Govt decide to be patient while staking the moral high ground – or were they just told to be patient and wait by order of those with bigger sticks.

Why do I feel they’re again frantically window dressing a failure - “New Zealand will be at the front of the queue to be getting vaccines"

Unfortunately it is quite difficult to overcome the thought that things are being made up as they go along.The government is reactive rather than proactive and in the interim comforting words will fill the void. For instance, surely enough vaccines could have been sourced by now, well by now, to inoculate the frontline staff at MIQ etc, to at the very least, provide them personally some protection.What are they then considered to be, sacrificial guinea pigs?

What would we actually do though? To apply pressure to countries that produce the vaccines? Threaten to withold Manuka Honey? We're small fish

Then just tell the truth - stop the spin.

Yes, we're just small fish who have very little say in the order of things - we'll just have to wait our turn.

There, it's not that hard is it.

Being late to the vaccine party could possibly end up being a good thing. If the new variants evade the current vaccines or at least make them much less effective we might end up getting the "tweaked" vaccines saving us from the more infectious strains. Then again, the virus might mutate again...and round and round we go. The UK might regret being first of the starting line...

That's what viruses do - every year you get a different flu shot. So, at the rate this virus is mutating you'll be getting a new shot every couple of months or so. Ever wanted to live the junkie life?

What I was wondering is given the variants that defeat the vaccine now number 3. The South africa, the Amazon & the kent stand will a new vaccine protect against all 3 variants . Or do we need a new vaccine for each variant?

According to youtube, the virus spikes remain the point of contact with humans, and the spikes are that with which the vaccines are designed to in affect, melt. Should the virus mutate too much then said spikes will be ineffective binding to the lung cells and virus will lose its potency.

In short as long as the virus is effective the vaccines are effective.

I see on the ministry of health's covid website that Maori and pacifica have priority along with front line workers. I'm of Anglo Celtic stock so does that mean my heritage protects me more than others from covid? Serious question because are they claiming a genetic component here?

No Ponzikiwi. Nowdays you are a second class citizen. Get over it.

More likely a health, social and economic inequity.

https://www.theguardian.com/world/2020/apr/22/racial-inequality-in-brita...

In other countries (USA and UK are the cases in aware of, but likely others too), death rates have been much higher for those in minority ethnic groups. Maybe partly caused by lower vitamin D levels being associated with darker skin, but also due to more common comorbidities, and other health inequality issues.

Quite reasonable to prioritise those at most risk. It would make a nice change from the many ways our health system discriminates against Maori.

OK so a Maori lawyer on 500k gets the jab before a pakeha labourer on $20 an hour. If its genetic then that's understandable. But socio economic reasons doesn't discriminate.

There's always multiple ways to slice things. Obviously we slice things by age and find that the elderly are more vulnerable. We slice things by comorbidities and find people with heart disease, diabetes etc are more vulnerable. We slice it by ethnicity and find Maori are more vulnerable.

My conclusion is to prioritise the elderly, and those with comorbidities, and Maori, as well as front line workers more likely to be exposed. Is it just the prioritisation of Maori that is problematic for you, or are you upset about 80 year olds getting the jab before you too?

No I'm not..

30 year old Maori lawyers yes...you sound like a big govt kind of person? Do you have a problem with banks creating money and blowing up asset bubbles and inequality?

And is there any evidence that 30 year old Maori lawyer will receive the jab particularly early? Maori are only actually mentioned in group 1, where Maori > 65 together with care home residents will be prioritised over other >65 year olds. Presumably as they (as a group) are more at risk. You're fighting a straw man here.

https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-nov...

I have no interest in having the other discussion you've raised.

I'm in.

News of vaccine is good shot for an otherwise ailing economy largely propped by the housing Ponzi & the feel good effect of housing investors ( specuvestors!!). Borders may open with travel bubbles . Travel & tourism stirs up.Air NZ starts recalling furloughed crews & activating mothballed aircraft. More jet fuel sales to boost revenue for companies like Zip energy. Things looking upbeat.

yes and don't forget if someone overseas has had a jab we can start opening the immigration taps again

ah yes the carbon neutral immigrants.