Pfizer-BioNTech Vaccine to arrive this quarter
RNZ Wellington, February 3, 2021
The Pfizer-BioNTech Vaccine has been provisionally approved by Medsafe, with certain conditions placed on the company.
In its assessment of the Vaccine, the medicines regulator met with the Medicine Assessment Advisory Committee (MAAC) for six hours on February 2, 2021 to receive advice and recommendations.
Mandatory compliance
In a statement, Medsafe said that the MAAC supported the decision.
However, the provisions mean the company must meet 58 conditions that are placed on it.
Medsafe group manager Chris James said that of these, 52 relate to requiring additional manufacturing data from the company, for instance as it upscales its manufacturing.
“Six of the conditions relate to additional clinical information such as regular updates from clinical trials, and ensuring we receive any information on safety concerns from around the world,” he said.
Speaking at Waitangi, Prime Minister Jacinda Ardern said that the Vaccine was expected to arrive in the first quarter of the year but could not put a firm date.
Jacinda Ardern on who gets first
Once here, it would be “ready for use, ready for rollout,” with hotel cleaners, security guards and border workers at the airport among those at the front of the queue.
“Those most at risk of getting Covid-19 will receive the Vaccine first, with the broader community accessing the Vaccine from the second half of the year. Subject to expected delivery of the first batch of the Vaccine, we will start vaccinating first our border workers and the people with whom they live. 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,” she said.
Ms Ardern encouraged all to get vaccinated and said that people could have confidence in the Vaccine and the process followed by Medsafe to approve it.
Year of the Vaccine
“I have said 2021 is the year of the Vaccine. It is a full-year programme that we have just begun. We are not in a race to be first, but to ensure safe and timely access to Vaccines for all New Zealanders. Getting vaccinated will save lives, and this is the next job of the team of five million,” she said.
Covid-19 Response Minister Chris Hipkins said that following Medsafe’s approval, Health Ministry officials will advise the government about the ‘decision to use’ the Vaccine.
“This will essentially set out who are most suited to receive the Pfizer-BioNTech Vaccine, such as age ranges. The first Pfizer-BioNTech Vaccines are expected to arrive in New Zealand by the end of the first quarter. Once vaccination of our border workers starts, we expect it to be completed within two to three weeks,” he said.
Checks and counterchecks
Medsafe said that it would continue to monitor use of the Vaccine in the country including analysis of any potential side effects, which it said may include a sore arm or headaches as with other Vaccines.
Mr James said that a full assessment on the Vaccine’s safety, effectiveness and quality to guide the approval decision started in November 2020.
“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. All the data is considered and then we complete a benefit-risk assessment, which allows us to balance the benefits of the Vaccine against any known risks such as side effects,” he said.
Mr James said that there may be some minor side effects such as a painful arm and headaches but these are not uncommon in other Vaccines.
“We also wanted to ensure that the Company can manufacture the Vaccine to a high quality, and that all batches are consistent,” he said.
Medsafe’s website includes more information on the Vaccine, including the medicine datasheet and full list of ingredients. Other details specifically tailored for consumers will also be published.
New Chapter in counter-attack
Director-General of Health Dr Ashley Bloomfield said that the decision brought about a new chapter in New Zealand’s response to the pandemic.
“I want to reassure New Zealanders that we will also be applying the same rigour to all subsequent Vaccine applications,” he said in a Statement.
While Dr Bloomfield highlighted the decision as a “significant milestone,” he warned: “There is more work to do, we are not out of the woods yet. Vaccination is a key next step in our ongoing response to this virus. It is also a good point to recognise the incredible amount of work New Zealanders have put in to support our successful response to date,” he said.
Previously, he said he was confident that New Zealand would receive a Covid-19 Vaccine by the end of March.
“We will be ready to start vaccinating people as soon as a Vaccine arrives, and at this time the first Vaccine that we are expecting is Pfizer in this quarter,” he said.
Alternative Supplies
Last week, Pfizer said in a Statement that it was on track to deliver the first doses to New Zealand in February, and committed to its agreement to supply 1.5m doses during 2021.
If delays with Pfizer’s Vaccine were to occur, New Zealand had other Vaccines to fall back on, Bloomfield said. New Zealand has agreements with AstraZeneca, Novavax and Janssen as well for the Pfizer-BioNTech Vaccine.
Australia approved the Pfizer product last week. BioNTech and Pfizer this month raised their supply goal for this year to 2 billion doses, up from a previous aim of 1.3 billion.
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