BioNTech, Fosun Pharma get full regulatory approval for COMIRNATY in individuals 12 years and older in Hong Kong
Shanghai: BioNTech SE and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. have announced that the Fosun Industrial Co., Limited (as a sub-licensee of Fosun Pharmaceutical Industrial) has received the certificates of registration as pharmaceutical product in relation to the official registration of the monovalent COVID-19 vaccine (also known as BNT162b2 or COMIRNATY Original) and the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (also known as COMIRNATY Original/Omicron BA.4/BA.5) by the Health Bureau of the Hong Kong Special Administrative Region of the People's Republic of China ("Hong Kong") which is equivalent to a Biologics License Application.
The full regulatory approval of both the companies' monovalent and Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine follows the emergency use authorization of the companies' monovalent COVID-19 vaccine in Hong Kong in March 2021. This makes COMIRNATY the first and currently only variant-adapted vaccine available as a booster dose for individuals 12 years and older which has been granted approval in Hong Kong. The companies' monovalent COVID-19 vaccine is approved as a primary course of vaccination for individuals 12 years of age. In addition to vaccine access via governmental vaccination centers, individuals 12 years and older can now receive COMIRNATY vaccines at medical institutions or clinics in Hong Kong, with a local medical prescription.
While the companies' monovalent COVID-19 vaccine for individuals 12 years and older contains 30-µg of mRNA encoding for the spike-protein of the wild-type of SARS-CoV-2, the bivalent COVID-19 vaccine contains 15-µg of mRNA encoding for the spike-protein of the wild-type of SARS-CoV-2 and 15-µg of mRNA encoding for the spike protein of the Omicron BA.4/BA.5 sublineages of SARS-CoV-2. Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.
Clinical data from an ongoing Phase 2/3 trial demonstrated a robust neutralizing immune response one month after a booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Immune responses against BA.4/BA.5 sublineages, which are currently the prevalent sublineages in Hong Kong and many regions in Asia, were substantially higher for those who received the bivalent vaccine compared to the companies' monovalent COVID-19 vaccine, with a similar safety and tolerability profile between both vaccines. One-month after a booster dose of the bivalent vaccine, Omicron BA.4/BA.5-neutralizing antibody titers increased 13.2-fold from pre-booster levels in adults older than 55 years of age, and 9.5-fold in adults 18 to 55 years of age, compared to a 2.9-fold increase in adults older than 55 years or age who received the original booster vaccine. These results suggest that a booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine may induce a higher level of protection against the Omicron BA.4 and BA.5 sublineages than the companies' monovalent COVID-19 vaccine.
Further, an analysis examining the immune response induced by the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine against newer Omicron sublineages, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1., showed that neutralizing antibody titers against emerging Omicron sublineages increased 3.2- to 4.8-fold compared to the companies' monovalent COVID-19 vaccine.
COMIRNATY Original has been authorized for emergency use (''EUA'') for the government vaccination program in the Hong Kong Special Administrative Region and Macau Hong Kong Special Administrative Region since March 2021; vaccination was commenced in the Taiwan region since September 2021. COMIRNATY Original/Omicron BA.4/BA.5 was available to citizens in Hong Kong and Macau through the government vaccination program since December 1, 2022.
On 16 March 2020, BioNTech and Fosun Pharma announced a strategic collaboration to develop and commercialize COVID-19 vaccines based on BioNTech's mRNA technology platform for Greater China Market including Mainland China, Hong Kong Special Administrative Region and Macau Hong Kong Special Administrative Region and Taiwan region.
