The Press

Kiwis will have to wait once vaccine approved

- BridieWitt­on

A Covid-19 vaccine will need to gain Medsafe approval, expected to take several months, even if it’s already rubber-stamped by trusted overseas regulators.

And a GP leader says doctors will need more funding, staff and direction if they are at the forefront of administer­ing a vaccine.

Medsafe, which usually takes close to two years to approve a vaccine, has allowed pharmaceut­ical companies to make rolling applicatio­ns – updating Medsafe as more data comes in – to speed up the process.

Britain could give regulatory approval to Pfizer-BioNTech’s

Covid-19 vaccine this week, while the United States’ Food and Drug Administra­tion said it would meet on December 10 to discuss whether to authorise the vaccine under emergency use.

New Zealand has pre-ordered

1.5 million doses of the PfizerBioN­Tech vaccine, which will protect 750,000 people as a double dose is needed.

The first vaccines, which must be kept at -70 degree Celsius, could be rolled out by early 2021.

The Government has also agreed to buy 5 million vials of a single-dose vaccine from Janssen Pharmaceut­ica once it finishes clinical trials and passes regulatory approvals.

But Dr Helen Petousis-Harris, former director of the World Health Organisati­on’s global advisory committee on vaccine safety, said emergency-use authorisat­ion had a different risk to benefit assessment.

‘‘The tolerance for reactions needs to be a lot higher [than emergency-use authorisat­ion] because we don’t have people dying right now. If you’re in the US, you’ve got a crisis,’’ she said.

Medsafe will analyse a ‘‘huge stack of data’’ and look at any NZspecific requiremen­ts.

‘‘It is not going to get the big tick in New Zealand unless they are satisfied,’’ she said. ‘‘They have really got their work cut out for them now.’’

A Medsafe spokesman said the regulator could make a decision within a few months, once it had the full dataset.

‘‘We cannot give an exact timeframe due to the variables involved but – using a rolling submission processes and building on any earlier approvals of trusted regulators in Australia, UK, Canada, Europe and the USA – we expect to progress quickly,’’ he said.

Dr Bryan Betty, medical director of the Royal New Zealand College of General Practition­ers. said GPs would need clear direction around who gets the first doses.

Frontline Covid-19 workers, including border and healthcare staff, are expected to receive the first doses. People more susceptibl­e to Covid-19 – including older communitie­s as well as Ma¯ori and Pasifika – are next in line.

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