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 yesterday to receive advice and recommendations.

In a statement, Medsafe said the MAAC supported the decision.

However, the provisions mean the company must meet 58 conditions that are placed on it.

“Of these, 52 relate to requiring additional manufacturing data from the company, for instance as it upscales its manufacturing,” Medsafe group manager Chris James said.

“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.”

The regulator said 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.

James said a full assessment on the vaccine’s safety, effectiveness and quality – to guide the approval decision – started in November last year.

“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,” he said.

“All the data is considered and we then complete a benefit risk assessment, which allows us to balance the benefits of the vaccine against any known risks such as side effects. We have determined there may be some minor side effects such as a painful arm and headaches – these are 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.”

Medsafe’s website includes more information on the vaccine, including the medicine data sheet and full list of ingredients. Other details specifically tailored for consumers will also be published.

In the statement, Director-General of Health Ashley Bloomfield said the decision brought about a new chapter in New Zealand’s response to the pandemic.

“I want to reassure New Zealanders we will also be applying the same rigour to all subsequent vaccine applications.”

While 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’s also a good point to recognise the incredible amount of work New Zealanders have put in to support our successful response to date.”

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 we’re expecting is Pfizer in this quarter,” he said.

Last week, Pfizer said in a statement it was on track to deliver the first doses to New Zealand in February, and committed to its agreement to supply 1.5 million 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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