Medicines regulator Medsafe has provisionally approved the Pfizer/BioNTech vaccine (Comirnaty) for Covid-19 to be used in New Zealand.

Director-general of health Dr Ashley Bloomfield and Medsafe group manager Chris James outlined the process involved in a joint statement this afternoon (Wednesday February 3).

The decision to approve the vaccine follows a robust assessment of the safety, effectiveness and quality of the vaccine, they said.

Ashley called the provisional approval of the vaccine “a significant milestone" for New Zealand.

The decision had been “carefully considered” every step of the way. 

“It’s only been made after following the vigorous assessment processes which are an integral part of all New Zealand’s decision-making around medicines,” he said.

Chris said Medsafe 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.

“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.

Chris said Medsafe’s assessment went to the Medicines Assessment Advisory Committee (MAAC) yesterday (Tuesday February 2) for its review, so the committee could provide Medsafe with advice and recommendations. The MAAC is made up of a range of industry experts from around New Zealand, and it met for six hours to help Medsafe come to a decision.

The MAAC supported Medsafe's proposal to grant provisional approval for the Pfizer/BioNTech vaccine.

“Provisional approval of the vaccine allows us to place conditions on the company,” Chris said, adding that Medsafe has placed 58 conditions on the approval for the Pfizer and BioNTech vaccine - including regular updates from clinical trials and information on safety concerns.

Ashley Bloomfield acknowledged the ongoing commitment of New Zealanders during the pandemic.

“This provisional approval is very much the start of a new chapter in our COVID-19 response and I want to reassure New Zealanders we will also be applying the same rigour to all subsequent vaccine applications,” he said.