No change to vaccine timeline despite new strains
Australia expects its medicines regulator to approve the Pfizer vaccine by the end of the month.
New Zealand does not have any plans to fast-track its Covid-19 vaccine roll-out in light of the highly infectious United Kingdom and South Africa strains caught at the border.
Australia recently brought forward its vaccine roll-out from late March to mid-to-late February amid fears about the mutated strains, and there have been calls from politicians for New Zealand to do the same.
But the Ministry of Health still expected to start vaccinating frontline workers from the start of the second quarter – aiming for April – and the public in the second half of the year, a spokesperson confirmed.
This week, National Party leader Judith Collins called for the roll-out to be accelerated, saying New Zealand had ‘‘fallen behind the rest of the world’’.
ACT leader David Seymour also criticised the timeline, saying New Zealand had to get vaccines approved to minimise the chance of a ‘‘catastrophic outbreak’’ of these more virulent strains.
However, the ministry said New Zealand ‘‘is not in the position’’ of other countries dealing with emergency Covid-19 situations and community outbreaks, resulting in ‘‘very different’’ risk profiles. The UK – first in the world to begin administering the Pfizer/BioNTech vaccine – is aiming to vaccinate 15 million people by mid-February as it faces an acute and overwhelming outbreak of the virus.
However, it suggests the timeline could change in response to community transmission.
The spokesperson said Medsafe – the regulatory body which needs to approve a vaccine – was continuing to ‘‘actively assess the best approach for the New Zealand context, including any community outbreaks, as it works through the approval
processes’’. Australia expects its medicines regulator, the Therapeutic Goods Administration (TGA), to approve the Pfizer vaccine by the end of the month so vaccinations can start in February, which is when it also hopes to receive approval for the AstraZeneca vaccine.
The spokesperson said Medsafe was working closely with TGA to ensure its assessment was as ‘‘streamlined as possible’’ while ensuring requirements for vaccine safety, efficacy and quality were met.
The delayed roll-out of the vaccines gave New Zealand an advantage, public health expert Professor Michael Baker said earlier. ‘‘We will know if there are any adverse effects that were rare and not previously detected. Our regulatory authorities will have a lot more data and they can do a very careful assessment of all the vaccine candidates,’’ Baker said.
There are two pathways for approval for a medicine or vaccine in New Zealand, via the Medicines Act. The first is full approval (section 20 of the Medicines Act) – the pathway for most medicines. The second is provisional approval (section 23 of the Medicines Act).
This is a time-limited, conditional approval, which allows for medicines (or vaccines) to be approved for early access often based on less available data from clinical trials when there is a significant clinical need or risk.
This pathway allows authorities to place conditions on the approval, such as only approving for specific patient groups, requiring specific monitoring of patients, or requiring additional data to be provided by a certain time. The ministry said it would likely use this route, provisional approval, for Covid-19 vaccines, due to the ‘‘limited’’ data available.
On Monday, Collins stated New Zealand should consider ‘‘emergency use’’ vaccine provisions for border workers, seen in other countries, ‘‘before it is too late’’. But the ministry said New Zealand did not have an ‘‘emergency use’’ authorisation.