China greenlights homegrown pneumococcal, HPV vaccines for the market — breaking grips by Pfizer, Merck
Pfizer’s dominating pneumococcal vaccine Prevnar 13 finally has a rival — and it’s neither Merck nor any of the small biotechs trying to topple the megablockbuster.
China has approved a pneumococcal 13-valent conjugate vaccine developed by a unit of Walvax Biotechnology, as an alternative option mainly for infants and children 6 weeks to 5 years old. On the same day, regulators also announced they have OK’d Cecolin, an HPV vaccine for women aged 9 to 45 developed by Xiamen Innovax.
With over 15 million newborns in just 2018, and given that pneumococcal disease is the main cause of death for children under the age of 5, the country “has a huge clinical need for the vaccine,” according to the National Medical Products Administration.
The homegrown vaccine has scored a broader label than Prevnar 13, which nabbed an OK in 2016 chiefly for babies up to 15 months old.
National Business Daily reported that Prevnar 13 can cost up to $430 (RMB$3,000) per treatment. Walvax spokespeople told the local publication that their new product will be priced at an advantage to Pfizer’s entrenched rival but not too low.
It may be another three months before the first vaccines could be administered following manufacturing clearance, National Business Daily added.
Yuxi Walvax, the subsidiary in charge of Walvax’s vaccine R&D business, is a rare bright spot in a troubled operation. The Shanghai-listed company was embroiled in a vaccine scandal a few years back when a different unit focused on selling overseas products was found to be hawking problematic batches. In 2019, Xinhua noted other than Yuxi Walvax, all of its other branches (which make plasma products and monoclonal antibodies) are registering losses.
The biotech is already marketing a 23-valent pneumococcal polysaccharide vaccine, a Diphtheria, Tetanus and Acellular Pertussis combined vaccine, and several meningitis vaccines. It’s also received funding from the Bill and Melinda Gates Foundation to develop new HPV vaccines targeting HPV-16 and -18.
That’s the same types of HPV covered by Innovax’s Cecolin, which would compete with GSK’s older Cervarix and Merck’s Gardasil (both tetravalent and 9-valent). GSK has partnered with Innovax on other HPV vaccine candidates.
As the first homegrown HPV vaccine, Cecolin will sell for $47 (RMB$329) per vial, EEO reported. Younger girls only need two shots while women 15 or above require 3. That compares to around $186, $114 and $86 for current 9-valent, tetravalent and 2-valent options as observed in a Shanghai hospital, respectively, the local outlet added.
Both Walvax’s and Innovax’s new offerings were approved under the priority review pathway.