Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced that Comirnaty (BNT162b2) and Comirnaty bivalent vaccine have been registered as drug/biologic products in Hong Kong. They can now be used as basic immunization for people aged 12 and above, and as a booster shot for people aged 12 and above, respectively, in the special autonomous region.
Previous Approvals and Partnerships
Previously, Comirnaty (BNT162b2), alongside pediatric dosages and the Comirnaty bivalent vaccine, obtained Emergency Use Authorization (EUA) in Hong Kong and special import approval in Macau. Fosun Pharma is partnered with Germany’s BioNTech (22UAy.DE) on the development of Comirnaty in the Greater China region. The product was approved for immunization in Hong Kong and Macau, followed by Taiwan in March and September 2021, respectively.
Vaccine Profile and Bivalent Formulation
The Comirnaty bivalent vaccine, another mRNA licensed – in by Fosun Pharma, is a reiteration and complement to Comirnaty. Each dose of the bivalent vaccine contains micrograms of mRNA encoding spike protein of the original strain and 15 micrograms of mRNA encoding spike protein of Omicron BA.4/BA.5 variants. It has been approved for import and vaccination in Macau and Taiwan previously.
Future Prospects and Strategic Implications
The registration of Comirnaty and its bivalent vaccine in Hong Kong marks a significant step for Fosun Pharma in expanding its presence in the vaccine market. By leveraging its partnership with BioNTech and the innovative mRNA technology, Fosun aims to address significant unmet medical needs and improve public health outcomes in the region.-Fineline Info & Tech