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Medsafe explains their process to approve the Pfizer vaccine

Author
Newstalk ZB,
Publish Date
Wed, 3 Feb 2021, 5:32pm
MedSafe Group Manager Chris James signing the gazette notice to grant provisional approval to the vaccine. (Photo / Supplied)
MedSafe Group Manager Chris James signing the gazette notice to grant provisional approval to the vaccine. (Photo / Supplied)

Medsafe explains their process to approve the Pfizer vaccine

Author
Newstalk ZB,
Publish Date
Wed, 3 Feb 2021, 5:32pm

New Zealand has the green light for our first Covid-19 vaccine.

The Government says after a rigorous assessment process, Medsafe's granted provisional approval to the Pfizer BioNTech jab.

The Medicines Assessment Advisory Committee held a six hour meeting yesterday to help Medsafe come to the decision.

Covid-19 Response Minister Chris Hipkins says Health officials will now advise on who's most suited to get this specific jab - including age ranges.

He says the first shipment's still expected by the end of March - but they're making sure everything's ready to go in case of an earlier arrival.

Medsafe has placed 58 conditions on the approval - from requiring the company's manufacturing data as it scales up production to extra clinical updates.

Group Manager Chris James says the company must continue to give ongoing clinical and manufacturing data.

"As company's upscale their manufacture from making 10,000 doses to 100,000 doses, they need to provide us with information to make sure the vaccine is still very high quality."

Auckland University vaccinologist Helen Petousis-Harris says this is no cause for alarm.

She says it ensures the quantity of vaccines being produced doesn't affect the quality.

"That's completely normal and I'm sure there's likely been much larger lists than that in the past."

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