Home COVID-19 COMIRNATY® Bivalent COVID-19 Vaccine is Officially Approved as Regular Imported Vaccine by the Pharmaceutical Administration Bureau of Macao SAR
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COMIRNATY® Bivalent COVID-19 Vaccine is Officially Approved as Regular Imported Vaccine by the Pharmaceutical Administration Bureau of Macao SAR

SHANGHAI, CHINA  20 January 2023 – On January 20, 2023, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) announced that COMIRNATY® Original/Omicron BA.4/BA.5 bivalent COVID-19 vaccine (also known as COMIRNATY® Bivalent COVID-19 Vaccine) is officially approved as a regular imported vaccine by the Pharmaceutical Administration Bureau of Macao Special Administrative Region of the People’s Republic of China (“Macao SAR”). It is indicated as a booster dose for individuals aged 12 years and older who have completed the primary vaccination course against COVID-19. After this approval, people in need can now receive the COMIRNATY® vaccines at qualified medical institutions, which are approved by the Health Bureau of Macau Special Administrative Region, in Macao SAR, with a local medical prescription.

In May 2022, the monovalent COVID-19 vaccine COMIRNATY® (30 mg per dose) (also known as BNT162b2 or COMIRNATY® Original) for people aged 12 years and older was officially approved by the Pharmaceutical Administration Bureau of Macao SAR as a regular imported vaccine. Since November 1, 2022, the self-paid COMIRNATY® Original vaccination service has opened for non-local residents in Macao SAR, which is indicated as a primary course of vaccination against COVID-19 for individuals aged 12 years and older.

Starting from November 1, 2022, the Chinese government resumed the e-visa application for travel to Macao. On the same day, the self-paid COMIRNATY® Original vaccination service for non-local residents of Macao has been officially put into operation in the University Hospital of Macao. In order to meet the growing demand for vaccination, the second self-paid vaccination site in Macao, Kiang Wu Hospital, has been put into operation officially since December 21, 2022.

For the self-paid COMIRNATY® Original vaccination service for non-local residents of Macao, customers can make an appointment and pay through the GoSmart online platform designated by the supplier, Jacobson Pharmaceutical (Hong Kong) Limited. As for the self-paid COMIRNATY® Bivalent COVID-19 Vaccine, customers can make an appointment to get vaccination in Macao through the Fosun Health platform or other designated cooperation platforms after the self-paid vaccination service of the COMIRNATY® Bivalent COVID-19 Vaccine is officially put into operation in Macao SAR.

COMIRNATY® Bivalent COVID-19 Vaccine can effectively deal with Omicron sub-lineages

COMIRNATY® Bivalent COVID-19 Vaccine, an effective deal with Omicron sub-lineages, is an iteration and supplement to the COMIRNATY®, a monovalent COVID-19 mRNA vaccine (BNT162b2) which is already in the market. The COMIRNATY® 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 sub-lineages of SARS-CoV-2.

Clinical data from an ongoing Phase 2/3 trial demonstrated a robust neutralizing immune response one month after a booster dose of the COMIRNATY® Bivalent COVID-19 Vaccine. 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. These results suggest that a booster dose of the bivalent vaccine may induce a higher level of protection against the Omicron BA.4 and BA.5 sub-lineages than the monovalent COVID-19 vaccine.

In addition, as the Omicron BA.4/BA.5 subseries variant virus (including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1) that is currently raging in many Asian countries and regions, the COMIRNATY® Bivalent COVID-19 Vaccine produced a higher immune response comparing with the monovalent COVID-19 vaccine. The safety and tolerance of the two vaccines were similar. An analysis of the antibody response of the COMIRNATY® Bivalent COVID-19 Vaccine to the new substrain of Omicron virus showed that after inoculation with COMIRNATY® Bivalent COVID-19 Vaccine, the titers of neutralizing antibodies against BQ.1.1 and XBB.1 increased respectively by 8.7 fold and 4.8 fold.

On March 16, 2020, Fosun Pharma and BioNTech announced a strategic collaboration to develop and commercialize COVID-19 vaccines based on BioNTech’s mRNA technology platform for Greater China Market, including the Chinese Mainland, Hong Kong SAR, Macao SAR, and Taiwan region. COMIRNATY® Original has been authorized for emergency use (EUA) for the government vaccination program in the Hong Kong SAR and Macao SAR since March 2021. Vaccination was commenced in the Taiwan region in September 2021. In November 2022, The Health Bureau of the Hong Kong SAR granted Emergency Use Authorization (EUA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. In addition, the Pharmaceutical Administration Bureau of Macao SAR granted a Special Import Authorization for the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The COMIRNATY® Bivalent COVID-19 Vaccine has been vaccinated for the public in Hong Kong SAR and Macao SAR under the government vaccination programme since December 1, 2022.

Fosun Pharma has started to provide COMIRNATY® Bivalent COVID-19 Vaccine to the private medical system in Hong Kong SAR since January 6, 2023. People in need will be able to receive vaccines at their own expense at clinics or medical institutions that provide the COMIRNATY® Bivalent COVID-19 Vaccine.

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