Medsafe had already reviewed "mountains of data" provided to them by Pfizer. Photo / AP
Medsafe had already reviewed "mountains of data" provided to them by Pfizer. Photo / AP
A Wellington student who is immuno-compromised said she is reassured to see the Covid-19 vaccine going through the normal MedSafe process this week.
New Zealand's medical regulatory body Medsafe was seeking advice from the Medicines Assessment Advisory Committee on Tuesday about the Pfizer vaccine for Covid-19.
Medsafe is set toannounce its decision on the Pfizer vaccine today.
Victoria University student Grace Lily Young said she was grateful New Zealand was putting the Pfizer vaccine through the normal tests and regulations.
"For an immuno-compromised person it's so much more important to understand what goes into it and how it works," she said.
"It's so much more reassuring for New Zealanders to get that from MedSafe. If they explain that it's going to be safe for immuno-compromised people as well, that would be so awesome."
Auckland University vaccinologist Helen Petousis-Harris said Medsafe had reviewed "mountains of data" provided to them by Pfizer, as well as collaborating with regulatory bodies from other countries such as Australia.
"They will examine the data on safety very closely as well as the way the company assessed this," she said.
"MedSafe are there to protect the NZ population and ensure that all the drugs and medical devices used in our country are appropriately safe."
The Covid-19 vaccine developed by Pfizer and BioNTech must be kept at ultra-cold temperatures in its journey from the production line to a patient's arm. Photo / Getty Images
She also said vaccines that were not live were generally fine to use in immunocompromised people, and many people with various forms of compromised immunity had participated in the studies.
Young has central pain syndrome, which means pain is not communicated effectively between her brain and central nervous system.
"It's to do with the inflammation and damage of my nervous system so it's completely impacted my immune system," she said.
"If I were to get sick, it's going to impact me wildly differently to a person who is able to just get it out of their system because their immune system knows how to attack viruses."
Unlike most New Zealanders, Young spent the entire period of lockdown – at least six weeks – without leaving her apartment, because even the risk of going to the supermarket was too great.
"It's very important for the average New Zealander to get [the vaccine] so then people like me can just be that extra level of cautious when it comes to getting it."
She said even with after getting the vaccine she may find it difficult to go out in public if there is another outbreak.
"Even if I did have the vaccine I don't know if my behaviour would change because I'd just be so alert.
"It would have an impact on me personally and how I would do things because you've got the extra layer of protection – you almost come up to the level of the average person.
"It kind of makes you feel safer but still aware."
A Ministry of Health spokesperson said it was vital for New Zealanders to know Medsafe is undertaking robust assessments of Covid-19 vaccines, so they can feel safe in taking them.
Medsafe has streamlined its approval processes for faster access, including allowing pharmaceutical companies to submit rolling applications rather than submitting all the data at once.
If they granted provisional consent, this would likely include conditions requiring the pharmaceutical company to provide data and information within an agreed timeframe, including clinical trial and manufacturing data as it became available.
