China approves emergency use of 1st home-grown mRNA COVID vaccine
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China's National Medical Products Administration (NMPA) approved CSPC Pharmaceutical's (OTCPK:CSPCY) (OTCPK:CHJTF) mRNA COVID vaccine SYS6006 for emergency use, marking the country's first domestically developed mRNA vaccine.
CSPC said SYS6006, which is an mRNA vaccine independently developed by the group, coverers Omicron subvariant BA.5's core mutation at the spike mutation positions.
The vaccine was granted emergency clinical trial approval by the NMPA in April 2022 and has completed phase 1, 2 and heterologous booster vaccination trials in China with over 5,500 people, the company noted.
CSPC said that one booster dose of SYS6006 has shown good cross-neutralization against Omicron BA.5, BF.7, BQ.1.1, XBB.1.5 and CH.1.1 strains in people who had received 2 or 3 doses of inactivated vaccine.
SYS6006 induced specific T-cell immunity against wild-type, Delta, Omicron BA.2 and BA.5 strains in both primary and heterologous booster vaccination, with immunity maintaining at high levels for an extended period and the cellular immune response against different strains about the same, according to the company.
In a heterologous booster clinical trial of 4,000 people conducted between Dec. 10, 2022 and Jan. 18, 2023, using a recombinant protein vaccine as control, the efficacy of SYS6006 was 70.2%, 7 to 28 days after booster vaccination. The efficacy of SYS6006 seen was 85.3%, 14 to 28 days after booster vaccination, CSPC noted.
The company said that the incidence of adverse events were substantially lower in the elderly group compared to the adult group, providing a better risk-benefit ratio in the elderly population.
China has not been using mRNA vaccines developed by Moderna (MRNA) and Pfizer (PFE)/ BioNTech (BNTX).