New Zealand's medical regulatory authority is still waiting for data from COVID-19 vaccine developers to make an assessment and begin the process to approve them for use.
COVID-19 vaccines have been administered in 51 countries already, according to Bloomberg data, but New Zealand is not one of them, despite COVID-19 Response Minister Chris Hipkins saying November we'd be "at the front of the queue".
Opposition party leaders are now demanding answers to "big questions" from the Government, such as why Singapore has already begun vaccinating border workers, and whether New Zealand has been pushed down the priority list.
"The Government has said manufacturers are focused on sending vaccinations to countries where thousands of people are dying every day, pushing New Zealand further down the queue," said National leader Judith Collins.
"But that argument doesn't wash when Singapore, who last recorded a COVID-19 death in November, has already begun vaccinating border workers.
"At the very least our Government should be making sure our frontline workers are vaccinated immediately, providing another layer of defence at our border."
It comes as more transmissible variants of the coronavirus - such as B.1.1.7. - have emerged across the globe, sparking fears that they could make it into the community in New Zealand.
"Vaccinating our border workers should be an immediate priority given how easily transmissible the new COVID variants are," said Collins. "The Government can't afford to be complacent given the seriousness of the situation."
ACT leader David Seymour said the Government needs to explain whether New Zealand's timeline for delivery of COVID-19 vaccines is based on supply constraints or because we've signed contracts that give the drug companies discretion to decide which countries need vaccines most.
A Ministry of Health spokesperson told Newshub the delivery timeline is not driven specifically by either of those factors.
"Rather, it is a range and combination of variables that we and companies have to weigh up that reflect the global situation, the speed at which companies can produce and deliver vaccines, the risk profile of each country, the regulation process in each country and the rate and severity of infection."
The Government has invested in a portfolio of four vaccines - 750,000 doses from Pfizer/BioNTech, 5 million from Janssen, 3.8 million from the University of Oxford/AstraZeneca, and 5.36 million from Novavax.
"We now have agreements in place with four providers, covering three different types of vaccine technology and we have secured more than enough doses to cover our entire population plus the Pacific," Prime Minister Jacinda Ardern said in December.
Ardern said vaccination of the general public would begin in the second half of the year and it would be dependent on Medsafe sign-off.
By contrast, the Pfizer-BioNTech vaccine has now been cleared for use across North America, Europe and the Middle East, and vaccination campaigns have begun in at least 51 countries, according to Bloomberg's research.
The Ministry of Health says Medsafe is currently waiting for data from vaccine developers for regulators to make an assessment and clear the vaccines for use.
"This is happening much faster than in normal circumstances as we work closely with Australian medicines regulator, the Therapeutic Goods Administration (TGA), to approve the Pfizer/BioNTech vaccine," the spokesperson said.
"Many of our international peers and some Australian states are dealing with genuine emergency situations where the immediate risks of the virus outbreaks outweigh the risks of bringing forward rollout timeframes.
"New Zealand is in a very fortunate situation where that is not what we are dealing with so we are able to work through a thorough, but streamlined approval process with Medsafe."
The spokesperson said the goal is to have border workers vaccinated within two weeks of the vaccines arriving in the country "and we are geared up and ready to do that".
How do vaccines get approval?
There are two pathways for approval of a medicine or vaccine in New Zealand via the Medicines Act. The first is full approval, which is the pathway for most medicines.
The second is 'provisional approval' which is time limited and conditional. This allows for medicines to be approved in New Zealand based on less available data from clinical trials where there is significant clinical need for early access.
This pathway sets a time limit and allows health authorities to place conditions on the approval, such as it only being approved for a specific patient group, require specific monitoring of patients or to require additional data to be provided by a certain time.
"It is likely we will use the provisional approval route for the COVID 19 vaccines due to the limited data available," the spokesperson said.
There is no 'emergency use authorisation' in New Zealand.
The spokesperson said those countries that have issued emergency authorisations have not approved the vaccines. Rather, they have issued them based on limited data in the context of public health emergencies in their countries.
Any unapproved use in New Zealand would be in the absence of reassurance from the regulator.
