Jason Falinski slams TGA’s slow Moderna Covid vaccine approval

The TGA took eight months to approve the Moderna Covid vaccine in Australia despite its use in the EU and US.

Northern Beaches MP Jason Falinski has taken concerns about the slowness of TGA approval processes to Health Minister Greg Hunt after the regulatory body waited eight months to approve the Moderna jab despite its approval for use in the US.

Saying it was a “concern for me for a long time”, Falinski asked “why (Moderna needed) to go through its own process around determining whether a medicine can be approved for use in Australia when it’s been approved by the EU regulatory body, when it’s been approved by the FDA in the United States, by Canada, by a whole bunch of other countries.”

The Moderna vaccine has now been approved for use in Australia. Picture: Orlando Sierra

“We have this not just with Moderna, but with a whole bunch of other medicines like cancer treatments for example can take years longer to get approved in Australia than they take in other jurisdictions,” Falinski, who represents the Northern Beaches seat of Mackellar, said on the ABC.

“I do think we need to have reciprocal recognition as part of our regime and as part of what the TGA does,” he said.

Falinski’s comments came after Prime Minister Scott Morrison publicly announced the approval of the Moderna Covid vaccine for use in Australia.

Federal Liberal MP for Mackellar Jason Falinski.

Prime Minister Scott Morrison with Greg Hunt. Picture: NCA NewsWire / Gary Ramage

The Moderna jab was approved for use in the US on December 18, 2020, and in the European Union on January 6 of this year.

Earlier this year the TGA was criticised for failing to approve life-extending and lifesaving cancer drugs such as Trodelvy, insisting it had to go through its own “sovereign” processes despite approval elsewhere.

“I’ve raised this with Greg Hunt (concerning why) the TGA does things like, for example, where pharmaceutical or drug companies will run tests in the United States and then the TGA will insist that they run a whole bunch of new tests which prove and supply no better information than they already have from the tests that have been run either in the European Union or in the United States,” Falinski said.

“And it seems to me like a lot of make-work going on, which ends up costing Australians more money, because to do this requires drug companies to run these tests here in Australia or somewhere overseas to create a new dataset which replicates information that they already have and that all costs money and that costs ends up being passed on to consumers here in Australia.”

Originally published as Jason Falinski slams TGA’s slow Moderna Covid vaccine approval