China has authorized the emergency use of its first recombinant subunit protein vaccine against COVID-19. According to the health committee of the eastern Anhui province, the vaccine is administered as a three-dose series separated by 28 days.
It is the first vaccine with the technique approved by the country for emergency use against COVID-19.
The vaccine, developed by Anhui Zhifei Longcom Biopharmaceutical and the Institute of Microbiology of the Chinese Academy of Sciences, embarked on clinical trials in June. By October, it finished phase 1 and phase 2 trials.
Phase 3 trials started in China’s Hunan Province in November and in Uzbekistan’s Tashkent in December. Researchers have also been holding trials in Pakistan, Ecuador and Indonesia. In March, Uzbekistan approved the vaccine.
“The results of the trials show that no serious adverse effects were detected after vaccination, and the level of produced neutralizing antibodies is comparable to other recombinant protein and mRNA vaccines used in the world,” the committee said.
The Anhui authorities stressed that production of this vaccine does not require high biosafety-level facilities. The vaccine production is not associated with a biosafety risk and can be scaled up very quickly. Costs are significantly reduced, and the vaccine is easy to store and transport.
Anhui Zhifei Longcom Biopharmaceutical has already built a production line with a capacity of 300 million vaccine doses a year, which is enough to vaccinate 100 million people.
Researchers note that rather than injecting a whole inactivated pathogen to trigger an immune response, like previously approved vaccines, subunit protein vaccines contain purified pieces of the virus’s protein to train the immune system. These fragments are incapable of causing disease, making such vaccines very safe.
US biotech company Novavax is the maker of another recombinant nanoparticle subunit vaccine for COVID called NVX-CoV2373, whose phase-three trials results released last week showed it was 96.4 percent effective against mild, moderate and severe disease caused by the original COVID-19 strain. The mRNA vaccines, developed by Pfizer and Moderna, both have a protection rate of around 95 percent.
With the emergency use approval of the recombinant protein vaccine, China added a fourth COVID-19 shot to its arsenal. China had already given conditional market approvals for four vaccines manufactured by Sinopharm, Sinovac and CanSino.