Kiwis will have to wait once vaccine approved
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.