Plans to fast-track COVID vaccine approval

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The Ministry of Health is planning to fast-track the approval process for a COVID-19 vaccine, and won't rule out offering a supplier indemnity from any potential claims resulting from its use.

It says Medsafe will ensure a vaccine is safe for use, and it will not be used on people unless clinical data suggests it is safe and effective.

This week, pharmaceutical companies Moderna and Pfizer announced they are launching trials of a COVID-19 vaccine which they say, if successful, could lead to approval and widespread use by the end of the year.

More than 150 coronavirus vaccine candidates are in various stages of development, with some two dozen prospects already conducting human testing.

In a statement, a Ministry of Health spokesperson says it's looking at how it approves vaccines.

"As part of the COVID-19 vaccine strategy, the Ministry is working to develop an expedited regulatory approval process that will still maintain standards.

"Medsafe will ensure that any vaccine for COVID-19 will be of acceptable efficacy, quality and safety before it is used in New Zealand.

"Clinical data will be required to ensure any vaccine is safe and effective before it is used on people. The process will be run by Medsafe."

The Ministry won't rule out offering indemnity to a vaccine supplier, as has happened previously.

Documents obtained under the Official Information Act show the previous Labour government accepted liability when it sourced a bird flu vaccine.

In May 2007, the Ministry of Health obtained 100,000 vaccines from Baxter Healthcare, at a cost of up to $3.4 million.

But as part of the purchase, the government had to provide indemnity to Baxter.

"It is not practical to conduct a normal trials process with this vaccine, so Baxter cannot license the vaccine in the normal way," the report, sent to then-Finance Minister Michael Cullen, and then-Health Minister Pete Hodgson, says.

"It is also not possible to know ahead of time how effective the vaccine will be against any H5 pandemic virus that may develop within the shelf life of the vaccine."

The Ministry says every potential supplier of the vaccine has the same conditions - indemnity "from any claims arising from the use of the vaccine".

While it's deemed a financial risk, it's determined to be worth it for the potential benefits if the bird flu pandemic worsened.

RNZ has put questions to Megan Woods, the Minister of Research, Science and Innovation who is leading the vaccine strategy work, about whether the government would consider taking liability for a COVID-19 vaccine.

Meanwhile, as part of that strategy, Pharmac says it is seeking information "regarding COVID-19 vaccine research, manufacture and supply, including supplier willingness to consider a range of different commercial scenarios for supply to New Zealand".

It says it has not sought commercial proposals for the supply of a vaccine.

Pharmac listed eight technology platforms it is considering for a vaccine, but says it is open to other technology also.

The vaccine types were: Inactivated virus; live attenuated virus; DNA-based vaccine; RNA-based vaccine; non-replicating viral vector; replicating viral vector; protein subunit; and virus-like particle.

The government has dedicated $37m to the COVID-19 vaccine strategy, which includes support for local research and manufacturing, and support for international research.

-RNZ/Ben Strang.

4 comments

Squeak, Squeak

Posted on 30-07-2020 08:40 | By Yadick

Offering indemnity, unproven, unknown effectiveness. I'm certainly no Guinea pig. Who knows what the results could be. The outcome could even be worse - a stronger and worse pandemic. Is this more about trying to play the hero, try to wear the cape . . .


Needs must...

Posted on 30-07-2020 12:40 | By morepork

...when the Devil drives. As long as being vaccinated is not compulsory, we should be OK. People can evaluate and decide for themselves. Personally, I have some reservations about the process being short-cut, but I understand why it is. The datasets provided to support its use would need to be above suspicion, and like most people, I don't trust Big Pharma. We should have our own trials and analysis of results from independent research here in NZ, before buying any vaccine in bulk.


Vaccinations

Posted on 30-07-2020 15:17 | By Val.M

Offering indemnity shows they cannot guarantee it’s safety! The people receiving it should be the ones having the say on this. Or perhaps government officials, are going to offer to be the first ones to try the vaccines?


Rescue

Posted on 30-07-2020 17:04 | By Slim Shady

We can’t rely on a home made vaccine or the border will be shut forever. The motherland will come to the rescue. You can pay us in lamb chops.


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