The Press

Ki­wis will have to wait once vac­cine ap­proved

- Bri­dieWit­ton Health · Medical Activism · Medicine · Medical Treatments · Vaccines · United Kingdom · Pfizer · United States of America · U.S. Food and Drug Administration · New Zealand · Janssen Pharmaceutica · World Health Organization · Australia · Canada · European Union

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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