206. How many people who died from Covid were given Remdesivir? 207. Why did the TGA approve Remdesivir on next to no evidence when it was still being trialled and the WHO recommended against it?

Question Number: 214
PDR Number: SQ22-000584
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 206 The Therapeutic Goods Administration (TGA) does not hold medical treatment information on patients in Australia who have died from COVID-19. The TGA may receive adverse event reports relating to a specific treatment given to a patient.

Question 207 The Therapeutic Goods Administration (TGA) granted provisional approval to remdesivir for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised. Provisional approval was made on the basis of preliminary clinical data, as there is the potential for substantial benefit to this group of highly vulnerable Australian patients. The data submitted to support the quality, safety and efficacy of this medicine was thoroughly reviewed by the TGA and followed the same rigorous evaluation procedures used for all medicines approved in Australia. The decision to approve this treatment was made only once the TGA was satisfied that the data showed a positive benefit-risk ratio. The Product Information document for VEKLURY and the Australian Public Assessment report were published on the TGA website at the time of conditional approval. It is not true that the WHO recommends against the use of remdesivir. The World Health Organization (WHO) recommendations for VEKLURY were updated on 21 April 2022 following the publication of data from a clinical trial looking at the outcome of admission to hospital. Updated recommendations by the WHO included the use of VEKLURY in mild or moderate COVID-19 patients at high risk of hospitalisation. The WHO statement is available at: www.who.int/news/item/22-04-2022-who-recommends-highly-successful-covid-19- therapy-and-calls-for-wide-geographical-distribution-and-transparency-from-originator. Furthermore, on 15 September 2022, the WHO made further updates to their Therapeutic and COVID-19: living guideline (available at: www.bmj.com/content/370/bmj.m3379) following the final results of the WHO-sponsored SOLIDARITY study. The WHO now conditionally recommends remdesivir for the treatment of patients with severe COVID-19. The WHO continues to conditionally recommend remdesivir in those with non-severe COVID-19 at the highest risk of hospitalisation.