China’s National Medical Products Administration (NMPA) has granted emergency use authorisation (EUA) for CSPC Pharmaceutical Group’s messenger RNA (mRNA) vaccine, SYS6006, to treat Covid-19.

With this regulatory approval, CSPC Pharmaceutical is claimed to be the first company to receive approval for providing an mRNA vaccine in the country.

The latest authorisation from the Chinese health authority comes as cases of Covid-19 decline after a recent surge.

The independently developed SYS6006 vaccine has been designed to target some major Omicron variants.

In April, CSPC Pharmaceutical secured emergency clinical trial approval to conduct trials of the mRNA vaccine.

With more than 5,500 participants, the company has completed Phases I and II, along with heterologous booster vaccination clinical studies in the country.

In the trials, the vaccine demonstrated substantially fewer adverse effects on a group of elderly subjects compared with an adult group. In a study of 4,000 participants receiving a booster vaccination, it also showed an 85.3% efficacy after 14 to 28 days.

Injection site pain and grade 1 and grade 2 fever were reported to be the most common adverse events.

The mRNA vaccine’s booster dose also demonstrated a good neutralisation effect against Omicron subvariants BA.5, BF.7, BQ.1.1, XBB.1.5 and CH.1.1 in clinical trials.

The company reported a “good” safety profile for the vaccine in August last year.

The BBC reported that laboratories in China have sought to create an mRNA vaccine for years, after the country refused to approve foreign-developed vaccines for widespread domestic use.

The Chinese vaccines were found to be less effective in preventing deaths and severe illness compared to the mRNA vaccines in the studies.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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