1News can reveal long-awaited vaccines for monkeypox are at the ready for widespread rollout.
But they’re not yet approved for use here, limiting any big promotion or marketing.
From Tuesday, people can complete an assessment to see if they are eligible.
The government wants to get the vaccines out quickly, however Medsafe still needs documentation from the manufacturer, meaning it will roll out as an “unapproved medicine”.
One expert thinks this hasn’t been done for vaccines in New Zealand before.
It is illegal to promote or advertise unapproved medicines.
That means the government won’t say the name of the vaccine even though it’s about to become available.
“That’s right, we can’t,” Associate Health Minister Ayesha Verrall told 1News.
“But we are making sure that everyone has the opportunity for a funded visit with their medical practitioner to discuss whether the vaccine is right for them,” she said.
The rollout comes after the government flagged in August it was working to secure the smallpox vaccine Jynneos.
Making unapproved medicines available is a route recognised in the Medicines Act, but those same laws stop brand names being promoted, or their availability being advertised.
Nikki Turner from the Immunisation Advisory Centre called it a “slightly unusual situation”.
“It is difficult to talk about a vaccine that hasn’t been approved in New Zealand,” she told 1News.
“However I’m confident to talk about this vaccine because it does have international approval. It would be really good to get New Zealand approval to make it easier to spread information about it,” she said.
The government is equally confident it can still reach the people it needs to.
“We’re able to offer this vaccine even though it has not yet been approved by Medsafe provided people have a consultation with a medical practitioner,” Verrall said.
“We had a group of independent experts review the vaccine and they made a recommendation that we don’t delay making an offer under this avenue.”
One of the reasons unapproved medicines can be allowed is if they are available overseas and have “acceptable quality, efficacy and safety,” and when approval in New Zealand hasn’t happened,” Medsafe says.
This vaccine is available in Australia, the United Kingdom, and the United States.
“We’ve acted as fast as we can,” Verrall said.
“The company who made the vaccine needs to submit the full set of information to Medsafe, as soon as Medsafe receives that information they’ll be able to complete their assessment.”
There have been 5000 vials of the smallpox vaccine obtained, enough for 20,000 people.
It comes amid a global shortage and more is expected to arrive later in the year.
The vaccine will be available for prescribing to eligible people from Monday January 16.
Joe Rich, from the Burnett Foundation, said his organisation had no safety concerns about the vaccine.
“It does create a bit of a frustration for us. While it’s unapproved we’re not allowed to promote it, which his challenging when we want to be getting as many people as possible,” he said.
“We know many in our community have been waiting to get access to the Mpox vaccine, so it’s very exciting.”
There have been 41 cases of monkeypox in New Zealand since the outbreak started.
Globally, there have been more than 83,000 cases in 110 countries with 66 deaths.
Infections, though, are waning.
The World Health Organization has signalled it hopes to declare an end to the emergency this year.
Who is eligible?
Those initially eligible for the vaccine include:
- Close physical contacts of people infected with Mpox, such as sexual partners and people who live in the same household.
- Gay, bisexual and other men who have sex with men (GBMSM) who have multiple sexual partners, and trans and cisgender women who are in intimate relationships with these eligible men.
- Those recommended to have the vaccine by medical specialists
What does the law say?
The vaccine can only be made available under section 29 of the Medicines Act 1981. This allows for ‘unapproved’ vaccines to be provided to individual medical practitioners for a particular patient after assessing the patient’s needs. The Act also prevents the brand name of the vaccine being promoted due to its ‘unapproved’ status.
Advertising the availability of unapproved medicines is prohibited by section 20 of the Medicines Act 1981. This means that the vaccine cannot be advertised, nor its availability promoted. It can only be offered by a medical practitioner to a consumer as a proposed medical treatment and then administered after a full informed consent process.