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Watch as Medsafe Group Manager Chris James signing the gazette notice to grant provisional approval for the use of Pfizer/BioNTech Vaccines in New Zealand. This includes the BioNTech COVID-19 Vaccine Comirnaty.
On Wednesday the Ministry of Health revealed a ‘robust' assessment ahead of Vaccine approval to ensure New Zealand gets the best quality and ensuring it is safe for people to take it.
Chris James said that the safety and quality is a priority rather than a ‘mess' of distributing them around the country.
“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 Mr 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.”
“We have also wanted to ensure the company can manufacture the vaccine to a high quality, and that all batches are consistent.”
Image: CC/ Sam Hudson
Director-General of Health Dr. Ashley Bloomfield mentioned in a press briefing that the Ministry of Health is focusing on ‘giving access' to a vaccine and that over time, people may gradually wish to take it.
“I have great confidence in the process that Medsafe has undertaken. Just emphasising as Chirs said no corners have been cut here. We have gone through a robust process,” said Dr Bloomfield.
“Every day, every week, we are getting more data from around the world as millions more by this vaccine and other vaccines are administered and there is nothing out of the ordinary from what we are seeing from a safety guard coming through. It is very assuring.”
“We always had anticipated that the wider general population rollout would be in the second half of the year from July onwards. That will be, as of course, we need much more Vaccines onshore from not just Pfizer but other manufactures.” — Dr Bloomfield assured the press that those Vaccines must go through an approval process.
The aim of the distribution and mass-rollout will be during the second quarter of 2021.
“Our aim would to have had every New Zealander able to access the Vaccine[s] before the end of the calendar year,” said Dr Bloomfield.
The Vaccine approval means COVID-19 spreading in the community will be further protected to prevent outbreaks from happening by giving it to border staff, managed isolation and quarantine staff members.
Image/Video: SUPPLIED/Ministry of Health
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