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Two-Component Recombinant COVID-19 Vaccine Granted Authorization In Mongolia

March 21, 2023 • 9:04 am CDT
U.S. CDC Mongolia map March 2023
(Coronavirus Today)

Jiangsu Recbio Technology Co., Ltd. today announced in a press release that by the Mongolian law on the prevention of COVID-19, the Company was granted an Emergency Use Authorization ("EUA") for its two-component recombinant vaccine ReCOV.

As of March 21, 2023, this is the first novel adjuvant recombinant subunit COVID-19 vaccine developed in China and approved overseas.

ReCOV is a recombinant COVID-19 vaccine developed by the Company with its technology platforms, including its novel adjuvant, protein engineering, and immunological evaluation platforms.

And the adjuvant used therein is its self-developed novel adjuvant BFA03.

The Company has successively conducted multiple late-stage clinical studies for ReCOV in China, the Philippines, the United Arab Emirates, Nepal, and Russia.

Studies have shown that ReCOV has demonstrated a favorable safety profile, with mild adverse reactions and no vaccine-related serious adverse events.

In particular, in a comparative clinical study with a positive control of Pfizer's mRNA vaccine, a sequential booster of ReCOV among subjects who have completed vaccination of inactivated vaccines induced durable and widespread cross-neutralizing antibodies against various Omicron variants, including BF.7, BA.5, BA.2.75, and BA.2, with all subgroups achieving superior levels of neutralizing antibodies as compared to the Pfizer's mRNA vaccine (with statistically significant differences).

The granting of the EUA to ReCOV in Mongolia will play a positive role in promoting registrations in other countries and regions.