A world-first surveillance program that tracks adverse reactions to vaccinations will soon monitor every vaccine on the national immunisation program (NIP). SmartVax was created in response to the 2010 Fluvax disaster, when a spike in convulsions and fever prompted Australias chief medical officer to suspend the flu vaccine program for children under five. “We needed to develop a better way to detect vaccine safety signals [a link between a vaccine and severe side effects] that could mobilise an effective response in a timely fashion, said co-developer and Perth GP Alan Leeb. “Especially for new vaccines and influenza vaccines, which change formulation every year.” SmartVax has monitored more than 1 million vaccinations since 2010 including the highly reactive meningococcal B vaccine Bexsero across more than 270 GP practices, Indigenous medical centres and hospital immunisation clinics. From 2019 the program will actively monitor all vaccinations on the NIP in real time, Dr Leeb announced at the Royal Australian College of General Practitioners annual conference on the Gold Coast this month. “We are collecting an extensive amount of data. We know where the vaccines are by postcode, we know the vaccine batch number, we know which arm it’s gone into. “What we don’t know [is] where the next problem is going to come from, but I think we are in a much better position now to be able to pick it up early and act on it if we do find something. “Its about improving confidence in our immunisation program and reassuring the public of the safety of our national program,” Dr Leeb said. So far, the results should do just that, he said. The rate of adverse events recorded by SmartVax is between 6 and 7 per cent. The bulk of the reactions are minor (swollen arms and fever), and a small proportion experienced fatigue, headache and skin rashes. The system detected no serious adverse events (such as convulsions, anaphylaxis, or Guillain-Barre syndrome) linked to vaccines and patients sought medical assistance in just 0.6 per cent of cases overall. “We are yet to detect any sort of signal that says we have a problem with a vaccine, he said. Medical attendance following vaccination was the most significant measure to track, Dr Leeb said. “If suddenly we get a huge spike and people start going back to their doctors we need to ask OK, whats going on. Lets have a closer look at it, he said. The SmartVax system sends patients or parents an automated text message three days after a vaccine has been administered, asking if they noticed any kind of reaction. If they respond yes or Y, they are asked if they sought medical attention and sent a two-minute survey to establish the nature, severity and duration and outcome of the reaction. In 2018 the system captured 25,000 encounters with children under five. The database contains over 87,000 meningococcal vaccinations, including quadrivalent Meningococcal ACWY vaccines and the meningococcal B vaccine (Bexsero). “Bexsero was fascinating because it was wildly reactive, Dr Leeb said. One in four children had an adverse reaction to the multi-dose vaccine, which is not currently on the NIP. “It was mostly fever or a nasty local reaction, and thats despite giving these children prophylactic paracetamol, Dr Leeb said. SmartVax had not identified any serious adverse events and medical attendance rates were still relatively low, he said. The alternative contracting the rare but potentially deadly condition was immeasurably worse. “[Meningococcal] is a rare disease but when people get it its devastating, Dr Leeb said. Health Minister Greg Hunt has encouraged B vaccine manufacturer GSK to re-apply Pharmaceutical Benefits Advisory Committee approval once additional data expected in 2019 is available. A spokeswoman for GSK said it was important to note the TGA has also assessed the adverse event profile of Bexsero and concluded there were no unexpected safety issues and that the number of reports were within expectations. SmartVax is in partnership with AusVaxSafety a national, collaborative active vaccine safety surveillance initiative led by the National Centre for Immunisation Research and Surveillance (NCIRS) and funded by the Australian Government Department of Health. Immunisations episodes currently monitored by SmartVax include childhood vaccines (51 per cent), flu vaccines (27 per cent), adolescent vaccines such as Gardasil (6 per cent), adult vaccines (1 per cent), elderly vaccines (2 per cent) and travel vaccines (13 per cent). Dr Leeb said the system only monitored for early reactions (within three days of receiving a vaccine). Aus Vax Safetys hospital program (AEFI-CAN) would pick up serious reactions that occurred outside of this window.
The Age, 22 October 2018 ; http://www.theage.com.au