Medsafe Provisionally Approves Pfizer/BioNTech Vaccine for COVID-19

The medicines regulator Medsafe has provisionally approved the Pfizer/BioNTech vaccine (Comirnaty) to be used in New Zealand following a robust assessment of the safety, effectiveness and quality of the vaccine.

In a joint statement released today, the Director-General of Health Dr Ashley Bloomfield and Medsafe Group Manager Chris James outlined the process involved.

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

“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.”

Dr. Bloomfield says he wants to reinforce that this has been a carefully considered decision every step of the way.

Chris James says 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.

“There are three key aspects assessed: the effectiveness of the vaccine, the safety data (both determined by clinical study results), and finally manufacturing data. Provisional approval of the vaccine allows us to place conditions on the company, “adds Mr. James.

Dr 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.

There is more work to do, we are not out of the woods yet  but the provisional approval of the Pfizer and BioNTech vaccine is a significant milestone,” says Dr. Bloomfield

Image credit: Ministry of Health