COVID-19: Pfizer-BioNTech vaccine approved in New Zealand but still no arrival date, as Government reveals who gets first jabs

The Pfizer-BioNTech vaccine has been given provisional approval in New Zealand but the Government has not disclosed when the shipment of 750,000 doses will arrive. 

But the Government has revealed who will get the first jabs. Managed isolation and quarantine (MIQ) cleaners, nurses, security staff and those who undertake health checks are first in line, as are custom and border officials, and airline staff. 

Prime Minister Jacinda Ardern announced last week that New Zealand's medicine regulator Medsafe was expected to approve the Pfizer vaccine this week, and it has lived up to her expectation, with the Ministry of Health finishing up a "robust assessment" of it. 

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

"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."

Medsafe group manager Chris James said the regulator 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. Other countries have approved vaccines under emergency measures. 

"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," he said. 

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

Ardern said the approval means the Government can now begin preparations for the first stage in the vaccination roll-out. 

"New Zealand is in a fortunate position in not having any current community outbreaks or transmission of COVID-19. Those most at risk of getting COVID-19 will receive the vaccine first, with the broader community accessing the vaccine from the second half of the year," she said. 

"Vaccinating our frontline staff will provide a critical additional line of defence to keep them well and to help prevent COVID-19 entering the community. It's an extra layer to help protect New Zealanders and our economy against a future outbreak."

The approval comes amid criticism from Opposition parties who have questioned COVID-19 Response Minister Chris Hipkins' statement last year that New Zealand was at the front of the queue for vaccines.

Data collected by Bloomberg shows the milestone of 100 million doses of COVID-19 vaccine administered worldwide has been passed, which ACT leader David Seymour said leaves "questions" for the Government. 

"If the medical regulator gives the all-clear to New Zealand's first vaccine today it won't change anything, we still won't have any vaccine for months," he said. 

"A very effective spin campaign is being waged whereby commentators well-disposed to the Government tell us we should actually be thankful to be at the back of the queue for rolling out coronavirus vaccines."

National leader Judith Collins wrote on Twitter that New Zealand is "hardly" at the front of the vaccine queue. She said the longer our border workers have to wait for the vaccine, the more vulnerable they are to the more transmissible strains of the virus. 

Medsafe's approval of the Pfizer vaccine comes with 58 conditions, 52 of which relate to requiring additional manufacturing data from the company, for instance as it up-scales its manufacturing. 

Six of the conditions relate to additional clinical information such as regular updates from clinical trials, and ensuring Medsafe receives any information on safety concerns from around the world.

"Medsafe's work doesn't stop here. As with all medicines and vaccines, we will monitor the use of the vaccine in New Zealand such as analysing reports of potential side effects," said James. 

Dr Bloomfield said there is "more work to do" and "we are not out of the woods yet", but he said the provisional approval of the Pfizer vaccine is a significant milestone.

"Vaccination is a key next step in our ongoing response to this virus. It's also a good point to recognise the incredible amount of work New Zealanders have put in to support our successful response to date."

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.

What is provisional approval?

Provisional consent means the pharmaceutical company must meet certain conditions, including supplying more data from its clinical trials around the world as they progress. This will happen at the same time as the vaccine is rolled out.

Provisional approval is not uncommon, according to the Ministry of Health, for instance the annual influenza vaccine is given provisional approval for the same reason.