New Zealand Grants Provisional Approval to Pfizer-BioNTech COVID-19 Vaccine with Conditions

New Zealand has provisionally approved the COVID-19 vaccine developed by Pfizer-BioNTech for use on Feb. 3 with certain conditions.

New Zealand’s regulatory body Medsafe with the Medicine Assessment Advisory Committee granted the provisional approval for the vaccine, but provided 58 conditions to be met by the pharmaceutical company, as well as a time frame to respond to the conditions.

According to Medsafe Group Manager Chris James, 52 of the conditions “relate to requiring additional manufacturing data from the company” while 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.”

Health Director-General Ashley Bloomfield called the decision a “significant milestone.”

The vaccines have yet to arrive in New Zealand, but officials have said they expect to receive it 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,” Bloomfield said.

According to Prime Minister Jacinda Arden, those at most risk of being infected would receive the vaccine first, which includes border workers, cleaners, security workers and nurses in isolation facilities, customs officials, airline staff, and hotel workers.

“I have said 2021 is the year of the vaccine. It’s a full-year program we have only just begun. We’re not in a race to be first, but to ensure safe and timely access to vaccines for all New Zealanders,” Arden said.

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