Provisional approval for COVID-19 treatments no substitute for vaccination
Pfizer and MSD’s oral treatments for COVID-19 have been granted provisional approval for use in adults at increased risk of hospitalisation or death, by the Therapeutic Goods Administration (TGA).
The decision to give Pfizer’s Paxlovid – which comprises two separate tablets of nirmatrelvir and ritonavir – and MSD’s Lagevrio – a molnupiravir capsule – was announced this morning.
The TGA said that either medication should be administered as soon as possible after diagnosis and within five days of the onset of symptoms, but stressed that neither treatment was intended to be a substitute for vaccination against COVID-19.
Both products are to be taken twice daily over a five-day course.
The regulator said the approval of the two treatments was subject to strict conditions requiring the sponsors to continue providing information regarding the longer-term safety and efficacy from ongoing clinical trials and post-market assessment.
More details in today’s issue of Pharmacy Daily.
