The decision by medicines regulator Medsafe to provisionally approve the Pfizer/BioNTech vaccine (Comirnaty) to be used in New Zealand follows a robust assessment of the safety, effectiveness and quality of the vaccine.
In a joint statement, the Director-General of Health Dr Ashley Bloomfield and Medsafe Group Manager Chris James have today outlined the process involved. “Medsafe began assessing the clinical data provided by Pfizer/BioNTech in November, working over weekends and through the Christmas break,” said Dr Bloomfield. “The data was provided on arolling basis, which streamlined the assessment process and enabled a timely approval without compromising the rigour of the review of the vaccine. “I want to reinforce that this has been a