Posted 26 October 2017
Recent US approval of GSK's shingles vaccine Shingrix has strengthened the case for an upcoming ARTG registration of the vaccine and positioned it as a significant competitor to currently NIP-listed Zostavax.
TGA review of the vaccine is currently underway, with a decision expected by the end of this year or early next quarter, while GSK has also indicated it intends to submit Shingrix to the PBAC for listing on the NIP.
Last November Zostavax, supplied by Seqirus in Australia although licensed by MSD overseas, was listed on the program for immunisation of 70-year-olds against the viral infection. According to the AMA, the federal government allocated around $100 million over four years to back the vaccine program with around 240,000 expected to be immunised each year.
Data from clinical trials of Shingrix however showed it could be a much more effective vaccine than Zostavax with GSK's vaccine remaining 90 per cent effective over four years compared to 70 per cent for Zostavax, whose efficacy also noticeably declines over time.
Prior to US approval, the FDA panel which recommended green light for the vaccine noted Shingrix was "a lot better than the vaccine we have now," referring to Zostavax.
In the US, MSD earned USD685 million from Zostavax in 2016 however GSK predicts Shingrix will outperform and take over the sales of the older vaccine with estimated sales of up to USD1 billion in 2022.
Shingles is caused by the reactivation of the virus responsible for chicken-pox in children which lies dormant at the nerve roots near the spinal cord after initial infection.
Both Shingrix and Zostavax are indicated for use in patients over the age of 50, although NIP listing of the latter has been restricted to only those in their 70s while private script purchase of the vaccine comes in at around $200.
Yajun Ma
yajun.ma@lushmedia.com.au