China okays its first mRNA vaccine, from drugmaker CSPC

China has approved its first domestically developed mRNA vaccine against Covid-19, CSPC Pharmaceutical Group Ltd said today, a major achievement in a country that 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, scientists said.

The news of China's first successful mRNA vaccine did not generate much buzz in domestic social media today, 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 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 a good neutralisation effect against Omicron subvariants BA.5, BF.7, BQ.1.1., XBB.1.5 and CH.1.1. in clinical trials.

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

CSPC did not say how many doses it plans to produce. It said the vaccine could be stored at 2-8 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."

Profits rise but breakthrough lacks buzz

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 percent in 2022 net profit today, helped by several newly launched generic drugs included in the national drug procurement programme.

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

"mRNA vaccines are an important new technology and will play a major role in the future to prevent infections," said David Heymann, an infectious disease specialist.

He said it was now important for the CSPC to share its data on the vaccine with the World Health Organization so the UN agency can assess the shot for use in international markets.

The lack of buzz domestically was unsurprising, said Zhi Qu, a scientist at Hannover Medical School in Germany who has written regularly on China's former zero-Covid policy.

While it is a significant scientific development, "from the perspective of Chinese society... the topics are not critical for Chinese people or the Chinese government anymore, they are moving forward to stimulate economic growth," he said.

- Reuters