Senate Community Affairs Legislation Committee, , 54:04 to 58:01
TGA officials address safety concerns regarding RSV vaccines, including monitoring for Guillain-Barré syndrome and the pharmacovigilance process.
Topics: Health, Public safety
Speakers: Speaker 11, Unknown Speaker, Speaker 16, Emily Harper, Prof Anthony Lawler, Dr Liz Develin
On the 19th of May last 2025, the TGA updated its safety advice regarding Gillian Barr syndrome following vaccination with a couple of the vaccines, citing US safety data. And that at that stage, the TGA stated that as of 24 March it had received no reports of GBS following either the vaccine in Australia. Is that still the case? And if not, how many reports is probably gone for the TGA? Has the TGA received a Gillian Barr syndrome following RSV vaccination to date? That probably more probably does more align with the TG. Sorry, Professor, I'll go to repeat that if you like, sorry.
I think if I understand the question correctly, it was is have we identified any additional indication or instances of Guernbaret syndrome following vaccination with RSV vaccine? Is that correct?
Uh with uh with RSV vaccine, yes, yep.
Uh thank you, Senator, for the question. Tali Fenner, Assistant Secretary, Pharmacovigilance Branch. I'd have to take that on notice to get the most up-to-date numbers. I don't have them at hand.
Okay. So it yeah, okay. So have there been any deaths following RSV vaccination? When then is the TGA going to update its published safety advice on RSV vaccination?
The T the TGA, our process, uh, I think we've spoken about this before, Senator.
Right. And so what when will that be?
I can't give you a date on on that. So we're as I said, we're c we're always undergoing that sort of monitoring activity, and so uh as signals become apparent, then we will look at them and they will move through depending on sort of uh a staged approach.
Yep.
Can you tell me if there's any active surveillance being done by the TGA to identify and investigate serious adverse effects following the RSV vaccination, including Gillian Barr syndrome?
Absolutely, we undertake a continuous monitoring process.
Right. What does that look like?
adverse event.
Okay, I think that's probably good time for me to hand over, Chair.