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In a statement sent to thisquality it was revealed that the Ministry of Health conducted a ‘robust’ assessment ahead of Vaccine approval for New Zealand.
The decision made by Medsafe who are the medicines regulator for New Zealand. It has provisionally approved the Pfizer/BioNTech Vaccine.
It follows an assessment of the safety and effectiveness of the Vaccine to be used. The Director-General of health Dr. Ashley Bloomfield and Group Manager Chris James outlined the process is involved in the distribution of Vaccinations.
Bloomfield says that the assessment consisted of effectiveness and safety data results that were both determined by clinical studies.
“Medsafe began assessing the clinical data provided by Pfizer/BioNTech in November, working over weekends and through the Christmas break,” said Dr Ashley Bloomfield.
“I want to reinforce that this has been a carefully considered decision 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.”
Medsafe said they needed to be assured that the Vaccine would be ‘safe’ and ‘effective’ before it could be used in a New Zealand setting — the results were of high quality according to the Ministry of health.
“There are three key aspects assessed: the effectiveness of the vaccine, the safety data (both determined by clinical study results), and finally manufacturing data,” said Chris James.
“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.
Mr James says that there had to be a clear line that the company can manufacture the vaccine to standards of high quality.
“We have also wanted to ensure the company can manufacture the vaccine to a high quality, and that all batches are consistent,” said Chris James.
“Medsafe’s assessment went to the Medicines Assessment Advisory Committee (MAAC) yesterday (2.2.21) 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.
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