Pfizer says it is on track to deliver the first doses of its Covid-19 vaccine to New Zelaand before the end of March, following its regulatory approval on Wednesday.

Medsafe granted the Pfizer/BioNTech vaccine provisional approval for use in New Zealand on Wednesday afternoon, allowing the two-dose inoculation to be administered to anyone 16 or over.

Those first in line will be health workers, border workers, their families, and those most at risk of death from Covid-19.

Director-General of Health Dr Ashley Bloomfield said the conditional approval followed months of hard work and an “extremely robust” process with “no corners cut”.

“Medsafe began assessing the clinical data provided by Pfizer/BioNTech in November, working over weekends and through the Christmas break,” Bloomfield said.

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

The decision was made after a roughly six-hour meeting of the Medicines Assessment Advisory Committee on Tuesday.

Bloomfield said the Government had spoken to Pfizer in recent days and it had assured him New Zealand was still on track to receive 450,000 doses of the vaccine before the end of March – enough for 225,000 border workers, their families and older people.

The vaccine would arrive by plane and go to one of nine new freezers in Auckland or Christchurch for storage. The Pfizer vaccine needs to be kept at minus 70 degrees Celsius until days before use.

A spokesperson for Pfizer confirmed the company was on track to deliver vaccines in the first quarter of the year.

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“Pfizer is committed to delivering on its agreement with the New Zealand Government to supply 1.5 million doses of our mRNA-based vaccine for Covid-19 over 2021,” the spokesperson said.

“Currently we are on track to deliver our first doses to New Zealand by the end of Q1 2021.”

OTHER VACCINES IN PIPELINE

Medsafe group manager Chris James said other vaccine manufacturers had sent applications and his 80-person staff had the capacity to assess four vaccines at once.

Janssen applied earlier and had been submitting data for some time, meaning James thought Medsafe was likely to make a decision in “the early part of the second quarter” of 2021. New Zealand has ordered 5 million doses of the Janssen vaccine.

AstraZeneca applied for approval in the past week and had started sending data over. New Zealand has ordered 3.8 million doses of this vaccine.

Novovax, the other vaccine manufacturer that the New Zealand Government has ordered 5.4 million doses from, had not yet applied to Medsafe.

Prime Minister Jacinda Ardern welcomed the approval.

“I have said 2021 is the Year of the Vaccine. It is a full-year programme we have only just begun. We are not in a race to be first but to ensure safe and timely access to vaccines for all New Zealanders,” Ardern said.

“The provisional approval of the Pfizer/BioNTech vaccine is a positive step in New Zealand’s fight against Covid-19. It means we can now begin preparations for the first stage in our vaccination roll-out.

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“Approval has been a very carefully considered and robust process, with safety the key priority. They have been in regular contact with medicines regulators around the world where the vaccine is already being rolled out. Allowing some time to study the vaccine roll-out overseas has provided extra assurance before starting our vaccination programme here.”

New Zealand has ordered enough of the two-dose Pfizer vaccine to cover 750,000 people, with an aim of covering the most exposed to Covid-19 and those most at risk of dying from it. Several other pre-purchasing agreements have been established for vaccines for the wider population.

Other vaccines are planned to vaccinate the entire population, starting from the middle of the year.

“Subject to expected delivery of the first batch of the vaccine, we will start vaccinating first our border workers and the people they live with. People such as cleaners, the nurses who undertake health checks in MIQ [managed isolation and quarantine], security staff, customs and border officials, airline staff and hotel workers will be among the first to get the vaccine,” Ardern said.

The Government had earlier said New Zealand would be “first in line” for the vaccine. It expected the first batch of 100,000 doses of the Pfizer vaccine would arrive before the end of March.

Covid-19 Minister Chris Hipkins said the Ministry of Health would give exact advice on who should get the vaccine first.

“This will essentially set out who are most suited to receive the Pfizer/BioNTech vaccine, such as age ranges,” Hipkins said.

“We expect the first Pfizer/BioNTech vaccines will arrive in New Zealand by the end of the first quarter but we are making sure everything is in place in case there is an earlier arrival.

“Once vaccination of our border workers starts, we expect it to be completed within two to three weeks.”

James said the process for approval had been rigorous.

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

“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.”

Fifty-eight reporting conditions have been placed on the use of the vaccine to make sure Medsafe is kept appraised of new data.

Bloomfield said the approval was the start of a “new chapter” in the country’s Covid-19 response.

“I want to reassure New Zealanders we will also be applying the same rigour to all subsequent vaccine applications.”