Medsafe could approve Pfizer and BioNTech vaccine as early as next week; Public vaccine rollout still not expected until the middle of the year

The Government says New Zealand’s medicines regulator, Medsafe, will next Tuesday receive advice from the country’s ‘Medicines Assessment Advisory Committee’ on whether to approve the Pfizer and BioNTech vaccine.

“Medsafe will consider its feedback and may decide to grant provisional consent, which will likely include conditions that require the pharmaceutical company to provide data and information within an agreed timeframe. This includes additional clinical trial and manufacturing data as it becomes available,” the Prime Minister and Minister for COVID-19 Response said in a statement.

“If the company agrees to any required conditions, Medsafe will formally gazette the decision to approve the vaccine’s provisional consent for use in New Zealand. That could happen as quickly as the day after the MAAC meeting.”

However New Zealand will continue to have to wait in a queue to get the vaccine.

The first vaccines are expected to arrive in the country by the end of March. Border workers and their close contacts will be vaccinated first. Doing so is expected to take two to three weeks. 

The plan is for the broader public to be vaccinated from the middle of the year.

Update from Northland

The woman who contracted COVID-19 in managed isolation and then tested positive when she left, hasn't passed the virus on to anyone else - test results suggest at this stage. 

Here is a snippet from a press release from the Ministry of Health:

Sixteen people have been identified as potential close contacts of the previously reported case in Northland. Of those, 15 people have returned negative tests, including a household contact of the case.

An additional close contact is awaiting their test result. A total of 157 staff from the managed isolation facility at Pullman Hotel have been tested, along with 192 guests currently in the facility. Of those, 30 still have test results to come, and all others have returned negative results.

Contact tracing staff are following up with 357 people who departed  the managed isolation facility between 9 and 24 January. Of that number, 325 have been contacted, are isolation and have been or are being tested. The remaining former guests are being followed up today.

187 people received a push notification as a result of having scanned into one of 31 locations of interest. A further location was added yesterday and is on the Ministry’s website. At this time 154 people have been identified as ‘casual plus’ contacts, as a result of either the push notification or after speaking with Healthline following media publicity. These people are being tested and are isolating until they receive their result.

The source investigation into how the Northland case was infected continues today at the managed isolation facility. This includes reviewing CCTV footage at the facility and looking at whether the infection may have occurred from person-to-person or surface transmission, or airborne transmission, including possibly the ventilation system.

More on the vaccine 

Here is a Government press release with more information:

The green light for New Zealand’s first COVID-19 vaccine could be granted in just over a week, Prime Minister Jacinda Ardern said today.

“We’re making swift progress towards vaccinating New Zealanders against the virus, but we’re also absolutely committed to ensuring the vaccines are safe and effective,” Jacinda Ardern said.

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

“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.

“Medsafe’s process not only ensures New Zealanders can feel confident in the vaccines we receive, it’s also been timely and means we will be ready to receive and administer vaccines as soon as Pfizer is in a position to send them.

“We’ve always known a safe and effective vaccine is a vital part of our COVID-19 response for our long-term control of the virus. 2021 is Year of the Vaccine,” Jacinda Ardern said.

COVID-19 Response Minister Chris Hipkins said COVID-19 vaccines will play a critical role in protecting New Zealanders’ health and wellbeing and, over time, will be a big step back to normality.

“Our first focus will be vaccinating our border and managed isolation and quarantine workforce and their close contacts. Once the vaccine arrives in New Zealand, we expect to be able to complete vaccinating this group within two to three weeks.

“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.

“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.

“If granted, the provisional approval will mean that Medsafe has sufficient information and assurance of both safety and effectiveness for it to allow vaccination to start – though there will be continued monitoring of the vaccine here and overseas.

“However, if Medsafe decides next week that some additional assurances are required before it grants approval, I accept their decision and am satisfied that it’s the right decision on behalf of all of us.

“It’s vital for New Zealanders to know that Medsafe is undertaking robust assessments of this vaccine and others so that we can be confident they’re safe and effective. It streamlined its approval processes for faster access, but it hasn’t cut any corners along the way.

“Safety is paramount and we want to be assured of this and also allow all New Zealanders the same opportunity of protection as other countries,” Chris Hipkins said.

Q and A

How long will the Medicines Assessment Advisory Committee take to make their recommendations?

We expect they will make their recommendations and give their advice to Medsafe, which has delegated authority from the Minister, on 2 February.

Who is on the Medicines Assessment Advisory Committee?

It is an 11-member committee of people from around New Zealand with a broad range of skills, such as biostatistics, infectious diseases, geriatrics, paediatrics, consumer interests, pharmaceutical chemistry and manufacturing, clinical pharmacology, toxicology, clinical genetics, rheumatology and psychiatry. Their identities aren’t public to protect them from external pressure in giving independent, free and frank advice about medicine approvals.

Where will the 2 February meeting take place?

The members are from around New Zealand so will meet virtually, as is usual practice. Key Medsafe members will also attend.

What happens next after MAAC gives their recommendations and advice on 2 February?

Medsafe will consider its feedback and may decide to grant provisional consent, which will likely include conditions that require the pharmaceutical company to provide data and information within an agreed timeframe. This includes additional clinical trial and manufacturing data as it becomes available. If the company agrees to any required conditions, Medsafe will formally gazette the decision to approve the vaccine’s provisional consent for use in New Zealand. That could happen as quickly as the day after the MAAC meeting.

When will the vaccines arrive in New Zealand?

We expect the first vaccines will arrive in New Zealand by the end of the first quarter but we are making sure everything is in place in case of an earlier arrival. We have broadly similar timing expectations as Australia. We acknowledge that there is international pressures for Pfizer and BioNTech to prioritise countries that have serious community transmission of COVID-19. As we have seen, timelines are changing often.

How has Medsafe streamlined its approval process?

We have prioritised the COVID-19 vaccines and allocated assessors for each vaccine candidate. We have close communication with the pharmaceutical companies about the timelines for getting their data and we’ve been accepting rolling submissions of data.

We received the first set of data from Pfizer last November. Last week, we received a large amount of data from Pfizer. 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. 

What happens if we choose not to use but Australia does?

New Zealand, like Australia, has to make a decision to use that will best support our Immunisation Programme from the portfolio of vaccines that have been purchased.

Why are you vaccinating border workers first?

We’ve always known that our greatest risk of COVID-19 entering New Zealand is at our border because the virus is rampant in many countries overseas, which is why we’ve put such tight measures in place at our border.

Protecting people working at the border and those at greatest risk of COVID-19 protects our entire population.

Our sequencing of who we vaccinate first only changes if our situation changes, such as if we have widespread community transmission.

How will we safeguard Māori?

Under the no/low transmission scenario, the best protection for everyone in New Zealand is to protect those who are most at risk of infection and their household contacts.

We are also reviewing the evidence for additional risk faced by Māori and Pacific peoples in relation to infection and transmission, more serious illness and death, and the cultural, social and economic impacts.

We will engage with key stakeholders and consider this alongside implementation options to determine the best approach.

Where will the first vaccinations of the general public be done?

Initial delivery settings are likely to be workplace and some community locations. We are engaging with DHBs on their local plans for the initial scenarios, including the providers they are likely to engage. As more vaccines become available, we will add new settings as we scale through the year.

How much will all the doses of vaccinations cost?

Cabinet has set aside just under $NZ 1 billion ($NZ 983.7 million) from the COVID-19 Response and Recovery Fund to secure access to COVID-19 vaccines.

This will be New Zealand’s largest immunisation roll out ever. We have never before attempted an immunisation programme of this scale, cost or complexity.

We’re aiming to vaccinate as many New Zealanders as possible – so that’s potentially 5 million people.

Do you have enough vaccinators trained for the rollout?

We’re planning for an extra 2,000-3,000 full time (or equivalent) vaccinators who will be trained and available when needed throughout New Zealand.

An initial call for expressions of interest has gone out via the COVID-19 surge workforce webpage, and we are working with partners across the health and disability system (including regulatory authorities for the relevant healthcare professions and occupational health providers) to engage additional vaccinator capacity across New Zealand. 

So far more than 1,100 people have registered their interest in being involved. In addition, more than 1,200 people have been trained as provisional vaccinators, ready to complete the COVID-19 vaccine training once available.

The Ministry of Health has contracted the Immunisation Advisory Centre to provide training on COVID-19 vaccines. This training is expected to begin in February — initially for those vaccinators who will deliver the Pfizer vaccine and then for nurses, doctors and pharmacists. This training will be available online and face to face across the country.