On April 26, Kexing Biotech announced that its inactivated vaccine for the new crown virus based on the Aomi Kerong variant has been approved by the State Food and Drug Administration for clinical research.
On the same day, Sinopharm said that the inactivated vaccine of the new crown virus of the Chinese biological Aomi Kerong variant was clinically approved by the State Food and Drug Administration, and a sequential immunological clinical study will be carried out in the 18-year-old and older population who have completed 2 or 3 doses of the new crown vaccination.
On April 27, China Cell Engineering, a holding subsidiary of Beijing Shenzhou Cell Biotechnology Group Co., Ltd., recently received a drug clinical trial approval issued by the Ministry of Health and Prevention of the United Arab Emirates, agreeing that the company's SCTV01C (2-valent) and SCTV01E (4-valent) recombinant new coronavirus variant S trimer protein vaccines will be conducted in the United Arab Emirates for Phase III clinical trials.
In the past few days, many people have consulted, and some people think that the Aomi Kerong vaccine can be vaccinated. Approved clinical and clinical use are two concepts, approved clinical only means to enter clinical trials, and it is necessary to select some specific populations that meet the requirements of the trial for vaccine efficacy and safety assessment. Clinical trials for drugs generally take years, but vaccines generally do not take so long, but also go through phase I, II, and III clinical trials. Experts said that if the products under research can be approved for emergency use after phase I and II clinical trials, it will take 3 months at the earliest.
Regarding the COVID-19 vaccine, the most critical issue is efficacy and safety, which is also the most concerned issue for all people. Sinopharm said that in the upcoming clinical trial study, the research team will pay great attention to whether the vaccine can stimulate the human body to produce specific neutralizing antibodies against Omilon, which is the core issue of effectiveness. And as an inactivated vaccine, safety aspects
, should be similar to the previous INactivated COVID-19 vaccine.
How is the Omiljung vaccine administered? Does it conflict with the previous vaccination?
Zhang Yuntao, chief scientist of Sinopharm China Biologics, said: From the clinical trial design of the inactivated vaccine of the Omicron strain, there are several designs.
1. After 3 months or 6 months apart for people who have been given two or three doses of inactivated vaccine, one or two doses of the Omiljung strain are given to observe safety and immunogenicity, that is, the level of neutralizing antibodies is produced.
2. For the "blank population" who have not been vaccinated with the original strain of the new crown vaccine, receive two doses of Theomilon inactivated vaccine and further observe the relevant data.
3. In the clinical design in Hong Kong, people who have received two or three injections of mRNA vaccine in the early stage are also injected with one or two injections of TheOmilon strain vaccine after an interval of 3 or 6 months to observe the relevant data.
4. Follow-up consideration should also be given to one or two doses of the Almichron strain vaccine in people who have been vaccinated with adenovirus vector vaccine and recombinant gene vaccine to obtain safety and immunogenicity related data.
From the perspective of time, if the clinical trial goes well, the inactivated COVID-19 vaccine of Omi kerong is expected to be available at the end of September. However, vaccination is only part of the epidemic prevention and control policy, not vaccination can sit back and relax, as long as the virus still poses a threat to people's health, it is inevitable to continue to normalize the epidemic prevention and control, and adhere to the dynamic zero policy without wavering.