China’s National Medical Products Administration (NMPA) granted conditional approval two Chinese-developed COVID-19 vaccines in less than 24 hours on Feb. 25. One of the vaccines approved was developed by Tianjin-based Cansino Biologics Inc., and the other by China National Pharmaceutical Group (Sinopharm) through its Wuhan Institute of Biological Products subsidiary.
In a two-paragraph statement on Feb. 25, the NMPA said it had “conditionally approved” Cansino’s candidate, Convidecia, which the company developed with the Beijing Institute of Biotechnology of the Academy of Military Medical Sciences. Cansino applied for emergency approval on Feb. 21.
In a separate statement, the NMPA announced a conditional approval of Sinopharm’s inactivated virus vaccine.
“It’s good news and I’m sure there will be international demand because of the urgent need for COVID-19 vaccines,” said Benjamin Cowling, a professor and head of the Division of Epidemiology and Biostatistics of the School of Public Health from the University of Hong Kong. “I believe [the approvals] will speed up productions and, perhaps, some of these vaccines could even be produced in other Asian countries to increase the supply more quickly.”
Cansino’s is the first non-replicating adenovirus type-5 (Ad5)-vectored COVID-19 vaccine to be approved in China, the NMPA said. However, since the approval is for emergency use only, the NMPA requested the company to continue with trials and submit follow-up data.
The company has emphasized that its vaccine works after a single shot. Interim data from a phase III trial of Convidecia shows overall efficacy of 65.28% at preventing all symptomatic COVID-19 28 days after a single dose and efficacy of 68.83% at preventing all symptomatic COVID-19 after 14 days, the company said. The vaccine has an efficacy of 90.07% at preventing severe disease after 28 days following a single dose.
“The data is supportive of the fact that the efficacy of Convidecia has met the relevant technical standards laid out by the World Health Organization as well as the relevant standards and requirements set out by the NMPA,” said the company.
Further data will come from an ongoing global multicenter, randomized, double-blind, placebo-controlled, adaptive designed phase III trial to evaluate the efficacy, safety and immunogenicity of the vaccine in people 18 and older. The trial includes 40,000 volunteers in 78 sites across five countries. It has been approved in China, Pakistan and Mexico.
Although the emergency approval is a key milestone for Cansino, this is not Convidecia’s first approval. In June 2020, the vaccine was approved by the Health Bureau of the Logistics Support Department of the Central Military Commission for military use only and as a military specially-needed drug, while it reached the phase III trials stage.
The NMPA also approved the emergency use of the inactive viral vaccine (vero cell) developed by Sinopharm’s Wuhan Institute of Biological Products, a subsidiary of Sinopharm.
“The vaccine is suitable for the prevention of the disease (COVID-19) caused by the new coronavirus infection,” said the Chinese regulator in its short announcement. Sinopharm will also have to submit follow-up data to obtain full marketing approval.
Sinopharm is also testing its vaccine in an international multicenter, randomized, double-blind, placebo-controlled trial in multiple countries. Interim data suggest efficacy of 72.51% after two shots.
This is Sinopharm’s second vaccine to win approval in China.
By the end of 2020, Sinopharm had produced almost 100 million doses of its vaccines and expected to produce close to a billion through 2021.
Separately, on Feb. 5, the NMPA approved the emergency use of Coronavac, developed by Sinovac Biotech Ltd., from Beijing.
Sinovac’s and Sinopharm’s vaccines were already being exported even before the domestic approvals were granted in China with countries like the UAE, Bahrain, Egypt, Jordan, Bolivia, Colombia and Argentina, among others, approving those vaccines first.
The vaccines already approved by the NMPA are part of a group of 16 vaccine candidates under development in China.
“I would expect that quite a few of the vaccines would ultimately be approved, which is good news because the more vaccines we can have in the next few months, the more lives can be saved,” Cowling said.