Source : 'Scrip Intelligence'
China National Biotec Group (CNBG) has filed a new drug application for its COVID-19 vaccines with China's National Medical Products Administration (NMPA). The move comes amid the recent reports from several global frontrunner developers of efficacies of over 90% for their candidates.
The submission indicates that China may get its first vaccine approved for broad use before year-end, despite no Phase III data from CNBG having been released and multiple studies conducted at overseas sites in the Middle East, Latin America still ongoing.
CNBG, a state-owned subsidiary of the giant Sinopharm Group Co. Ltd., is progressing two inactivated virus-based vaccines, for which it received the first approval for a Phase I/II trial back in April.
Ke Wu, the CEO of one Chinese vaccines firm, Wuhan-based BravoVax Co Ltd, told Scrip that the CNBG vaccine could get a conditional approval before the final clinical results are announced, given that the regulatory agency’s drug review wing, the Center for Drug Evaluation, has recently released new guidelines for such an approval pathway, in which vaccines for public health crises are included.
The guidelines, issued on 19 November, target two categories of products. The first is those for the treatment of severe, life-threatening diseases and for public health needs, for which clinical trials have demonstrated their efficacy and clinical value. The second category is vaccines that are urgently needed to respond to major public health emergencies or other vaccines that the National Health Commission has identified as urgently needed.
Such vaccines are eligible for conditional approval as long as one or two primary assessments of the Phase III data show that benefits outweigh risks, note the new guidelines.
As well as data requirements, manufacturing will be a challenge for CNBG, noted BravoVax's Wu. So far, there is a need for tens of millions doses and CNBG will need a complex manufacturing process for its inactivated vaccines compared to the mRNA-based candidates such as from Moderna, Inc. and Pfizer Inc./BioNTech SE.
Pricing is another possible obstacle. The Russian developers of the Sputnik V adenoviral vector-based vaccine have just said they will offer this at $10 per dose. ()
The cost of CNBG's vaccines will be higher and could easily be north of CNY100 ($15) per dose, given that the company has conducted Phase III trials around the world, adding to its development costs.
Another leading Chinese COVID-19 vaccine developer, CanSino Biologics Inc., has said it will prioritize quality and science over speed. Speaking at the recent Qiming CEO Summit, CEO Xuefeng Xu said the company is still conducting a global Phase III study with its adenovirus-based candidate, Ad5-nCoV.
This has already been used under an emergency authorization scheme in China and approved for administration to the military, with no adverse event reports. ()
By Brian Yang