Another Four Coronavirus Vaccines Approved for Clinical Trials in China

Another Four Coronavirus Vaccines Approved for Clinical Trials in China

A number of coronavirus vaccines have been approved for clinical trials in April 2022. Currently, the technical routes of the new coronavirus vaccines that have been marketed and are under development in China are mainly inactivated, recombinant protein, viral vector and mRNA vaccines.

Shanghai Stemirna’s Coronavirus mRNA Vaccine Receives Approval from SFDA

On April 30, the new coronavirus mRNA vaccine developed by Shanghai Stemirna was approved by the Chinese State Drug Administration (SFDA) to conduct clinical trials. It is reported that the vaccine approved for the clinical trial is an iteration of the vaccine developed for many coronavirus types. This vaccine includes the D614G mutation, which is found in many coronavirus mutant strains such as Delta and Omicron, and has a broad spectrum of protection against current coronavirus strains.

Technical Routes of 4 New Coronavirus Vaccines

From the technical route, among the 4 vaccines approved for clinical trials for coronavirus in China since April 2022, 2 are inactivated vaccines and 2 are mRNA vaccines.
On April 26, SFDA officially approved the inactivated vaccine of Omicron mutant strain of New Coronavirus developed by Kexing Holdings Biotechnology Co.
On April 4, Kexinuo Biologicals announced on the Hong Kong Stock Exchange that the new coronavirus mRNA vaccine developed by the company had received approval from SFDA for drug clinical trials.
On April 3, Shijiazhuang Pharmaceutical Group also announced on the Hong Kong Stock Exchange that its new coronavirus mRNA vaccine “SYS6006” had been approved by SFDA for clinical studies in China.

Industry experts analyzed the different technical routes of vaccines and said that traditional inactivated vaccines have mature technology and high safety, but the protective effect is more common; recombinant proteins can produce vaccines with better protection and safety with mature expression systems. Adenovirus vector vaccines have wide applicability but are limited by the choice of vectors and possible side effects. mRNA vaccine technology is more cutting-edge, and the new mRNA vaccine is the first large-scale vaccine. coronavirus vaccine is its first large-scale clinical application, and while it provides the most outstanding protective effect, its safety has yet to be verified.

They believe that the domestic vaccine industry continues to be in a high boom, with accelerated technology iterations and upgrades, heavyweight products coming to market one after another, and domestic innovative vaccines have become a support point to drive the industry’s sustained market growth.

In fact, since the end of February this year, Kexing Biopharm has been submitting clinical applications for inactivated Omicron variant vaccines to several countries and regions outside of mainland China, and on April 14, Kexing received clinical approval for its new inactivated coronavirus vaccine based on Omicron variant strain in Hong Kong. In addition, several other companies are also actively conducting overseas clinical trials.

On April 29, Suzhou Aibo Biotechnology Co., Ltd. announced that in response to the global coronavirus epidemic, its coronavirus R&D pipeline, Omicron variant coronavirus mRNA vaccine, was recently granted clinical approval in the United Arab Emirates.

Sinopharm’s 2 Omicron variant vaccines received clinical trial approvals for UAE

According to the official website of China Biotechnology on April 29, two inactivated Omicron variant vaccines from China Biotechnology Institute of Beijing and Wuhan Institute of Biological Products, and the recombinant vaccine developed by China National Institute of Biotechnology/National Engineering Research Center for Novel Vaccines, a total of three Omicron vaccines, were approved for clinical trials by the Ministry of Health in Abu Dhabi, UAE.

Foreign Pfizer and Modena advance pediatric vaccine licenses

In addition to a number of domestic pharmaceutical companies advancing clinical trials, foreign leading Coronavirus vaccine developers have also begun to actively promote the licensing of Coronavirus vaccines for children.

On April 28, Moderna sought from the U.S. Food and Drug Administration (FDA) its authorization for the Coronavirus vaccine for children under 6 years of age, which would be the first Coronavirus vaccine for children in that age group. Moderna noted in a statement that the vaccine is about 51 percent effective in preventing infection with the Omicron strain in children under 2 years of age and about 37 percent in children between 2 and 5 years of age, similar to the protections afforded by two doses in adults. on April 26, Pfizer and partner BioNTech said they had submitted an application to U.S. health regulators to authorize a third dose of the vaccine for children between 5 and 11 years of age.