China approves first domestic mRNA COVID-19 vaccine
In a study of 4,000 participants, the vaccine showed an efficacy of 85.3 percent 14 to 28 days after a booster vaccination.
China has approved its first domestically developed mRNA vaccine against COVID-19, the manufacturer said Wednesday, months after the relaxation of strict zero-COVID regulations sparked a surge in cases.
The vaccine, developed by CSPC Pharmaceutical Group Ltd, has been approved for “emergency use” by Beijing’s health regulator, the company said in a statement on Wednesday.
It showed high efficacy in a trial in which it was used as a booster shot for people who have received other types of vaccines, the company added, without giving further details.
China, whose homegrown vaccines are considered less effective than Moderna and Pfizer-BioNTech’s mRNA shots, has been racing since the early 2020s to develop vaccines using messenger RNA (mRNA) technology.
While traditional vaccines use a weakened or inactivated germ to prepare the body for a future attack from the real virus, mRNA inserts bits of genetic material with instructions that show the body’s cells how to produce a protein—in this case, the spiked protein. protein on the coronavirus that causes COVID.
The body’s immune system then activates antibodies to fight that spike protein, making it ready for when the real coronavirus enters.
The long-awaited approval
The much-anticipated approval came as infection rates across China have plummeted since it suddenly dropped its strict “zero COVID” restrictions in December, casting sales prospects for the newly approved vaccine as bleak.
But it would give China an additional option to deal with future outbreaks and a basis for development against newly emerging variants, scientists said.
News of China’s first successful mRNA vaccine did not cause much of a stir in domestic social media on Wednesday as the country returns to normal and borders are open again.
The top leaders declared a “decisive victory” over COVID last month.
CSPC said its vaccine trials showed side effects were significantly lower in an older group compared to an adult group, boosting China’s efforts to protect the frail older population.
The company said its independently developed mRNA vaccine SYS6006 targets some key Omicron variants and the booster dose showed good neutralizing 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 going through a flurry of infections, the vaccine showed an efficacy of 85.3 percent 14 to 28 days after a booster shot.
CSPC has not said how many doses it plans to produce. It said the vaccine could be stored at 2 to 8 C (35.6 degrees to 46.4 degrees F) for a long time.
The company received emergency clinical trial approval for the mRNA injection in April last year, around the same time as CanSino, another China-based company testing an Omicron mRNA booster injection.