NMPA grants EUA to CSPC Pharmaceutical’s Covid-19 vaccine

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 across the country after a surge recently.

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

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

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

In the trials, the vaccine demonstrated substantially less adverse effects in an elderly group compared with an adult group.

It also showed 85.3% efficacy after 14 to 28 days of a booster vaccination, in a study conducted in 4,000 participants.

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 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.

Laboratories in China have been trying to create an mRNA vaccine for years, where the country refused to give approval for foreign-developed vaccines for widespread use domestically, BBC reported.

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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