New Zealand regulator approves Pfizer-BioNTech COVID-19 vaccine

New Zealand medicines regulator Medsafe has provisionally approved the use of a COVID-19 vaccine jointly developed by U.S. drugmaker Pfizer Inc and Germany's BioNTech, the government said on Wednesday. "The provisional approval of the Pfizer-BioNTech vaccine is a positive step in New Zealand's fight against COVID-19," Prime Minister Jacinda Ardern said in a statement. "It means we can now begin preparations for the first stage in our vaccination roll-out."

The vaccines are expected to arrive in New Zealand by the end of the first quarter, the government said, adding people at highest risk would be vaccinated first before the broader community from the second half of the year. With vaccination drives underway in dozens of countries including the United States, India and China, pressure has been mounting on Ardern to start inoculations for the country's 5 million people.

She said Medsafe had been in contact with medical regulators around the world, and being able to study the roll-out of the vaccine elsewhere had provided it with extra assurances. "I have said 2021 is the year of the vaccine. It's a full-year programme 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," she said.

Opposition party leaders and critics have said New Zealand has fallen behind the rest of the world and risked losing its advantage after virtually eliminating COVID-19 through a tough lockdown and border closures. New Zealand's Health Chief Ashley Bloomfield said Medsafe has placed 58 conditions on the approval of the Pfizer-BioNTech vaccine related to additional manufacturing data and ensuring information is provided on any safety concerns elsewhere.

"We have determined there may be some minor side effects such as a painful arm and headaches – these are not uncommon in other vaccines," Bloomfield said.

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