The Pfizer-BioNTech Covid-19 vaccine has been provisionally approved by Medsafe for use in New Zealand.
It is the first Covid-19 vaccine to get sign off in New Zealand.
This announcement comes after Medsafe conducted a robust assessment on the safety, effectiveness and quality of the vaccine.
“I want to reinforce that this has been a carefully considered decision every step of the way,” said Director-General of Health Dr Ashley Bloomfield.
“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.”
The provisional approval means Medsafe (the government’s medical regulatory body) is able to place conditions on Pfizer-BioNTech. 58 conditions have been placed on the approval for the vaccine.
“Of these, 52 relate to requiring additional manufacturing data from the company, for instance as it upscales its manufacturing. Six of the conditions relate to additional clinical information such as regular updates from clinical trials, and ensuring we receive any information on safety concerns from around the world,” Medsafe Group Manager Chris James explained.
1.5 million doses have been ordered and are expected to arrive in March. This is enough to vaccinate 750,000 people.
Each person will need to have two doses of the vaccination, one month apart.
As long as there is no community transmission, these are the three main groups that will be prioritised to receive the vaccine:
- Border and managed isolation workers
- Health workers who are at the highest risk of exposure to the virus
- Household contacts of the two above groups
- High risk frontline health workers
- High risk frontline public sector and emergency service staff
- Older people
- Those with underlying health conditions
- At-risk health and social service workers
So far, clinical trials have observed that the side-effects from the Covid-19 vaccine are the same as what we see in other vaccines; sore arm, redness, headaches, fever and sore muscles with some allergic reactions.
The vaccine will be free of charge and will not be mandatory.