Coronavirus: Medsafe COVID-19 vaccine approval process 'important' for NZ - Ashley Bloomfield

The Director-General of Health is confident New Zealand will be ready to administer vaccines to border workers as soon as doses arrive, something that can't happen until our medicines regulator gives the green light. 

The timeline around vaccine delivery has been a hot political topic this month, with New Zealand not yet having access to any jabs despite more than 50 countries now administering doses. National's Judith Collins has said vaccinating border staff is an "economic and moral imperative", while Act's David Seymour has called assurances the doses are coming soon "unacceptably vague". 

Speaking to The AM Show on Wednesday, Dr Ashley Bloomfield said the expectation continues to be that vaccines will begin arriving  in the first quarter of the year and we will be ready to administer them to frontline workers. 

However, he explained that the greenlight is first needed from Medsafe. 

"None of the manufacturers will deliver their vaccine until there is approval. That is the first very important step. We have expedited that process. Medsafe staff have done some excellent work there," he said. 

On Tuesday, Prime Minister Jacinda Ardern announced that Medsafe may provide provisional consent to the Pfizer/BioNTech COVID-19 vaccine as early as next week. That has followed a process to ensure the vaccines are "safe and effective". 

"Medicines regulator Medsafe will seek advice and recommendations from the Medicines Assessment Advisory Committee (MAAC) next Tuesday, about the Pfizer and BioNTech vaccine," Ardern said. 

"The Ministerial expert advisory committee will review Medsafe's benefit-risk assessment of the pharmaceutical company's data and, depending on feedback, Medsafe may be able to grant provisional approval as soon as the following day."

Unlike in other countries which are struggling to contain the virus and are seeing thousands of deaths every day, New Zealand has no community transmission. Many nations that do have given vaccines an emergency authorisation, reflecting the severity of the situation and allowing them to be among the first to receive doses. 

Dr Bloomfield said the Medsafe process was worthwhile despite clinical trials already proving the general safety and effectiveness of the vaccines and millions of jabs having been administered without any significant side effects. 

"It is still a really important process. This is for New Zealand and it is for New Zealand in the situation we are in at the moment. Medsafe looks at the risks and benefits for the New Zealand situation.

"The great thing is that now that tens of millions of doses have been administered around the world, we are getting new safety data every week to help provide further assurance about the safety profile. It is not irrelevant."

Australia's medical regulator gave approval to the Pfizer-BioNTech vaccine on Monday, with local priority groups likely to be vaccinated from late February. It prompted Seymour to question why New Zealand was behind. 

"If we're constantly sharing information with our Aussie cousins, as the Government insists we are, why is it taking our medical regulator, Medsafe, longer to approve the Pfizer vaccine? And what do we think Medsafe might discover that the Australians haven't?"

The first set of data from Pfizer was received last November and another large batch arrived last week. 

"After assessing it, we've asked them some questions, for which we've requested a response in a week. Normally we'd give companies four months to respond," the Government said. 

Those working on the border will be the first to receive vaccines.

"These brave people have been protecting our country from this global pandemic during the past year and protecting them and those who share their households is a priority for us," COVID-19 Response Minister Chris Hipkins said on Tuesday.

"That will be the start of New Zealand's largest ever vaccination campaign. And that will take some time and the most important thing is when we finish not when we start. 

"However we do intend to get our front line staff vaccinated as soon as possible. Doing so will add another layer to our border defences. We hope to start vaccinating the wider population mid-year."

New Zealand has invested in four vaccines - 750,000 doses from Pfizer/BioNTech, 5 million from Janssen, 3.8 million from the University of Oxford/AstraZeneca, and 5.36 million from Novavax.