There has been some disquiet over the time taken to approve Covid vaccines for New Zealand, to a point resembling impatience.
This should now dissipate with the announcement by Medsafe that Pfizer/BionNTech doses purchased by the New Zealand Government are consented for use.
Pfizer and BioNTech agreed on October 12 last year to supply New Zealand with 1.5 million doses of their BNT162 mRNA-based Vaccine Candidate Against SARS-CoV-2.
The agreement was to supply of 1.5 million doses to be provided over the course of 2021 - subject to Medsafe approval. This is the first of 15 million doses purchased by New Zealand in a "diverse portfolio" of vaccines.
At the time of the agreement Pfizer and BioNTech began a Phase 2/3 safety and efficacy trial and, assuming positive data, hoped to initiate regulatory applications in the fourth quarter of 2020 and manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of this year. The Phase 3 clinical trial completed enrolment of 46,331 participants last month, with trials being conducted in Argentina, Brazil, Germany, Turkey, South Africa and the United States.
The US is taking 200 million doses of the Pfizer and BioNTech vaccine - so far, approved for emergency use only - with the companies expecting to deliver the last of the doses to Operation Warp Speed by July 31, 2021.
So why wait for our white-coats to confirm what peers at least as qualified, perhaps more so, have consented in overseas territories?
There are several reasons. Medsafe is tasked with evaluating applications for all new medicines, including vaccines, to ensure compliance with international standards and local requirements for quality, safety and efficacy.
One crucial aspect is whether the product will do as advertised. That is, the doses are of the potency being delivered to other populations and are new stock well clear of expiry concerns.
The other concern is, of course, safety. On this, MedSafe has made its conditional finding, clearly assisted by the vast amount of data from doses so far delivered.
The first rollout, to border and MIQ workforce, healthcare workers and their household contacts, is expected to take place in the first quarter.
The second phase, for the rest of us, is expected in the second half of this year, depending on manufacture rates and sign-off from Medsafe, under its now bedded-in expedited approval process.
The companies announced on January 27 that in-vitro studies demonstrated Pfizer and Biontech Covid-19 vaccine elicits antibodies that neutralised Sars-Cov-2 with key mutations present in UK and South African variants.
The role of MedSafe has not been concluded with the granting of consent yesterday, however. Medsafe continues to collect information on the safety and quality of medicines and vaccines after they have been approved.
In a process known as pharmacovigilance, MedSafe will monitor vaccine use in everyday practice; seek new information on vaccine safety; investigate any report of a new or changed adverse reaction; continue to assess risk of harm and benefits; advise healthcare professionals and consumers to promote the safe use of vaccines; and monitor the impact of any changes made.
We should all be watching on, patiently.