China OKs its first mRNA vaccine, from drugmaker CSPC

[March 22, 2023]  BEIJING (Reuters) - China has approved its first domestically developed mRNA vaccine against COVID-19, CSPC Pharmaceutical Group Ltd said on Wednesday, a major achievement in a country that has declined to use Western COVID shots to support domestic research.

China, whose home-grown vaccines are seen as less effective than the Moderna and Pfizer-BioNTech mRNA shots, has been racing to develop vaccines using messenger RNA (mRNA) technology since early 2020.

The long-awaited approval comes as infections have fallen sharply across China since it suddenly dropped its strict "zero-COVID" curbs in December, making the sales outlook for the newly approved vaccine moderate.

But it would give China an additional option to tackle future outbreaks and a base for development against newly emerging variants.

The news of China's first successful mRNA vaccine did not generate much buzz in domestic social media on Wednesday, as the country has returned to normal and its borders have re-opened.

Its top leaders declared a "decisive victory" over COVID last month.

CSPC said its vaccine trials showed adverse effects were substantially lower in an elderly group compared with an adult group, which could be help China, which has stressed the need to focus on protecting its vulnerable elderly population.

The company said its independently developed mRNA vaccine SYS6006 targets some major Omicron variants and its booster dose showed good neutralization effect against Omicron subvariants BA.5, BF.7, BQ.1.1., XBB.1.5 and CH.1.1. in clinical trials.

Patients lie on beds and stretchers in a hallway in the emergency department of a hospital, amid the coronavirus disease (COVID-19) outbreak in Shanghai, China January 4, 2023. REUTERS/Staff

In a study of 4,000 participants from Dec. 10 to Jan. 18 when China was experiencing a surge in infections, the vaccine showed efficacy of 85.3% 14 to 28 days after a booster vaccination.

CSPC did not say how many doses it plans to produce. It said the vaccine could be stored at 2 degrees to 8 degrees C (35.6 degrees to 46.4 degrees F) for a long time.

"The group has built a good manufacturing practice-compliant production plant (for the vaccine)," it said in a statement.

"Key raw materials and excipients are produced by the group, which enables independent control in the supply chain and significantly lower production cost."

The firm won emergency approval for clinical trials of the mRNA shot in April last year, around the same time as CanSino, another China-based company that is testing an mRNA Omicron booster shot.

CSPC reported a rise of 8.7% in 2022 net profit on Wednesday, helped by several newly launched generic drugs included in the national drug procurement programme.

Its shares rose as much as 7.7% after the result and news of the approval.

(Reporting by Bernard Orr; Editing by Miyoung Kim and Bernadette Baum; Editing by Clarence Fernandez)

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