Medsafe has conditionally approved the Pfizer vaccine for use in New Zealand and the first Kiwis to get it will be MIQ workers and their families.
The announcement was made at 2pm by the Ministry of Health and Prime Minister Jacinda Ardern said the conditional approval won’t stop use of the vaccine but will require Pfizer to continue providing rolling data.
“Subject to the expected delivery of the first batch of the vaccine, we will start vaccinating first our border workers and the people they live with. People such as cleaners, the nurses who undertake health checks in MIQ, security staff, customs and border officials, airline staff and hotel workers will be among the first to get the vaccine,” Ardern said.
Ardern said she and her family members will be vaccinated but they weren’t the priority – frontline border workers are.
“I will absolutely be vaccinated.”
Ardern said while the vaccine wouldn’t be compulsory for border workers, she expected there to be high uptake.
The initial batch is expected to cover every border worker and their close contacts.
Once border workers have been vaccinated there will be a tiered roll-out, with it moving to health workers and rest-home staff.
The recommended dose is two jabs, 21 days apart.
Ardern would not say what the policy would be for vaccinating Kiwis needing to travel overseas.
She’s hasn’t received any advice that the hold-ups in Europe would affect New Zealand’s delivery and blamed New Zealand’s wait for the vaccine on the fact we didn’t have people dying like other countries.
Ashley Bloomfield said the provisional approval was the “start of a new chapter” and a “significant milestone”.
Bloomfield said the Covid vaccine was still due in New Zealand by the end of March, but officials were ready to start jabs sooner if the stock arrived earlier.
The most important considerations were the safety, effectiveness and the quality of its production, he said.
Under provisional approval, ongoing clinical data and data from manufacturing sites must be provided, he said
The priority is to vaccinate people who are at the highest risk – those working at the border, he said.
That included all staff at our managed isolation hotels and those working at ports, he said.
The wider rollout of vaccines is expected to be from July onwards, he said.
Bloomfield said there were different potential scenarios in which vaccines would be administered.
Currently there was no community transmission, but that was a scenario officials had considered.
Bloomfield said the team regularly talked to Pfizer, which had reassured officials it was on track to deliver within the first quarter.
Medsafe group manager Chris James called Pfizer’s approval a carefully considered decision.
“We needed to be assured that the vaccine was safe and effective in a New Zealand setting.”
And that it was manufactured to a high quality, he said. “We have determined that this is the case.”
Medsafe had been working with Pfizer for a number of months and started receiving data back in November, he said.
The company had been allowed to provided rolling submissions of data as soon as it was available, he said.
“It is important that people understand we have not cut any corners in the assessment along the way while we worked to make a decision,” he said.
James said Medsafe’s assessment went to the medicine’s assessment advisory committee yesterday for a review which spanned about six hours.
The provisional approval had allowed Medsafe to place conditions on the company, he said.
James said 58 conditions had been placed on Pfizer and BioNTech, 52 relate to manufacturing information.
“They need to provide us with information to make sure the vaccine is still a very high quality,” James said.
There are also six conditions for additional clinical information.
“MedSafe’s work doesn’t stop there.”
They will be collecting reports of possible side-effects, he said.
James said the discussion yesterday was robust and lengthy because there was a lot of technical data.
Bloomfield said the vaccines would be transported here on board aircraft. They will come among a batch destined also for Australia.
Being confident we can maintain a “cold-chain” is important, Bloomfield says.
It needed to be kept between 2 and 8 degrees throughout transport, Bloomfield said, which was a standard the healthcare system was used to.
“It is already being used in countries around the world. So it is already being manufactured at scale.
“No corners have been cut here. We have gone through a robust process,” Bloomfield said, repeating what James said earlier in their press conference.
“Every day, every week, we are getting more data from around the world … it is very reassuring.”
Bloomfield said New Zealand had its own vaccine regulator. It had looked at summaries from other countries but also done its own work.
“We have 80 people at MedSafe that cover the medicines and medical devices regulation,” James said.
It was expected the virus would mutate and get “a competitive advantage” some might say, Bloomfield said.
What was promising was possible resistance or immunity to other strains after vaccines, he said.
Bloomfield said, over time, the number of people opposed to vaccines shrank as confidence grew.
“We have a very significant communications campaign under way.”
The Unite Against Covid-19 campaign had cost about $15 million and was an “incredibly good” campaign, he said.
Some of the latest advice to Bloomfield about injection protocol included that once the vaccine was administered, people should wait 30 minutes to check for allergic reactions, he said.
Bloomfield is very excited about receiving the vaccine but will be waiting his turn.
He does not fit into the description of prioritised border workers.
After those who are at most at risk then officials would look to vaccinate people who, if they got ill, were more at risk of a poor outcome, he said.
Bloomfield said that, regarding increased risk, there was better data about the effect of the vaccine on people with diabetes and heart disease etc.
It was beholden on officials to make sure border workers were confident in the information they received about vaccines, he said.
Frail older people in aged residential care were clearly in the highest risk category, he said.
Earlier today the regulator said it put the vaccine through a “robust assessment” of its safety, effectiveness and quality.
On vaccine hesitancy, research has indicated 70 per cent would get the vaccine and 20 per cent wanted more information. Ardern said those people could now have confidence because we’ve taken time to approve it.
Minor side effects identified are sore arms and headaches – like some other vaccines.
Ardern said safety was a “key priority” and now the Pfizer vaccine had conditional approval the Government could prepare for the first stage in the vaccination roll-out.
New Zealanders could have confidence in Medsafe’s decision, she said.
“They’ve been in regular contact with medicines regulators around the world where the vaccine is already being rolled out,” said Ardern.
“Allowing some time to study the vaccine roll-out overseas has provided extra assurance before starting our vaccination programme here.”
The process included a six-hour meeting by a panel of medical experts yesterday and 58 conditions have been put on the approval including additional manufacturing data, regular updates from clinical trials and ensuring safety concerns are relayed to Medsafe.
Following Medsafe’s approval, the Ministry of Health will provide advice to ministers about the “decision to use” the vaccine.
This advice will set out who are most suited to get this variety of the vaccine, such as age ranges and ethnicities.
It’s expected the first batch will arrive some time in March then it will take two weeks to vaccinate the entire frontline border workforce after the Pfizer doses arrive.
Bloomfield said he wanted to reinforce that every step of the process had been carefully considered.
“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.”
Who will get the vaccine?
The first Kiwis to get the vaccines will be frontline border workers – like cleaners, nurses, security staff, customs and border officials, airline crew and hotel workers – and the people they live with.
On advice from health officials, there will then be a roll-out of the national vaccination programme and the Government is aiming to vaccinate at least 70 per cent of the population but is hoping for 90 per cent.
It will be free to get the vaccine.
Ardern said vaccinating frontline staff would provide a “critical additional line of defence” to prevent them being infected with the virus and to keep Covid-19 out of New Zealand.
The Government will encourage all New Zealanders to get vaccinated.
“Getting vaccinated will save lives, and this is the next job of the team of five million.
“We have come far in the fight against Covid; getting vaccinated is key to locking in the gains we have made and protecting our hard-won freedoms.”
She said the vaccination programme would take a full year.
“We’re not in a race to be first, but to ensure safe and timely access to vaccines for all New Zealanders.”
What is the Medsafe approval process?
Medsafe began assessing the clinical data provided by Pfizer/BioNTech in November, working over weekends and through the Christmas break, said Bloomfield.
“The data was provided on a rolling basis, which streamlined the assessment process and enabled a timely approval without compromising the rigour of the review of the vaccine.
“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.”
Three key aspects were assessed: its effectiveness, safety and manufacturing data.
Medsafe Group Manager Chris James said once all the data had been considered the vaccine went through a benefit-risk assessment to weigh up any known risks with its benefits.
James said there may be minor side effects like a painful arm or headaches which were 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.”
The results of the approvals process then went to the Medicines Assessment Advisory Committee for approval. The six-hour meeting took place yesterday.
The committee supported the conditional approval of the vaccine.
There are 58 conditions for approval which relate to getting additional manufacturing data from Pfizer and BioNTech, regular updates from clinical trials and ensuring Medsafe receives information on safety concerns from around the world.
“”Medsafe’s work doesn’t stop here. As with all medicines and vaccines, we will monitor the use of the vaccine in New Zealand such as analysing reports of potential side effects. Medsafe’s website will have the latest published information around Pfizer and BioNTech vaccine,” said James.
“This will include the medicine data sheet, which includes all the known information about the vaccine including the full list of ingredients. Information specifically tailored for consumers will also be published.”
Bloomfield said the other three subsequent vaccines would go through “the same rigour” as Pfizer.
“Vaccination is a key next step in our ongoing response to this virus. It’s also a good point to recognise the incredible amount of work New Zealanders have put in to support our successful response to date.
“There is more work to do, we are not out of the woods yet — but the provisional approval of the Pfizer and BioNTech vaccine is a significant milestone.”