On April 26, Sinovac announced that its new coronavirus inactivated vaccine based on the Omicron variant has been approved by the State Food and Drug Administration for clinical research.
On the same day, Sinopharm Group said that China Bio-Omicoron variant new coronavirus inactivated vaccine received clinical approval from the State Food and Drug Administration, and will be 2 or 3 doses of the new crown vaccine after the completion of the vaccination. Sequential immunization clinical studies in people 18 years of age and older.
On April 27, China Cell Engineering, a holding subsidiary of Beijing China Cell Biotechnology Group Co., Ltd., recently received a drug clinical trial approval document issued by the Ministry of Health and Prevention of the United Arab Emirates. SCTV01C (2-valent) and SCTV01E (4-valent) recombinant new coronavirus variant S-trimeric protein vaccines are undergoing Phase III clinical trials in the United Arab Emirates.
In the past few days, many people have inquired, and some people think that the Omicron vaccine can be vaccinated. Approved for clinical use and clinical use are two concepts. Approved for clinical use only means entering clinical trials. It is necessary to select some specific groups of people who meet the test requirements to evaluate the efficacy and safety of vaccines. Clinical trials for drugs generally take several years, but vaccines generally do not need such a long time, but they also undergo Phase I, Phase II, and Phase III clinical trials. Experts said: If the product under development can be approved for emergency use after Phase I and II clinical trials, it will take 3 months at the earliest.
About the new crown vaccine, the most critical issue is efficacy and safety, which is also the most concerned issue of all people. Sinopharm Group said that in the upcoming clinical trial research, the research team will pay close attention to whether the vaccine can stimulate the human body to produce specific neutralizing antibodies against Omicron, which is the core issue of effectiveness. As an inactivated vaccine, the safety aspect
, it should be similar to the previous inactivated vaccine for the new crown.
How do I get the Omicron vaccine? Does it conflict with previous vaccinations?
Zhang Yuntao, chief scientist of Sinopharm China Biotechnology, said: From the perspective of clinical trial design of the inactivated vaccine of Omicron strain, there are several designs.
1. For people who have been vaccinated with two or three doses of inactivated vaccine, after 3 or 6 months interval, receive one or two doses of Omicron strain for observation Safety and immunogenicity, i.e. the level of neutralizing antibodies produced.
2. For the “blank population” who have not been vaccinated with the original strain of the new crown vaccine, receive two doses of the Omicron inactivated vaccine, and further observe the relevant data.
3. In the clinical design of Hong Kong, people who have received two or three injections of mRNA vaccine in the early stage are also injected with Omic after an interval of 3 or 6 months. One or two injections of the Rong strain vaccine, and observe the relevant data.
4. Follow-up consideration should be given to the population receiving adenovirus vector vaccine and genetic recombination vaccine, one or two doses of Omicron strain vaccine to obtain safety and immunogen sex-related data.
From the perspective of time, if the clinical trial goes well, the Omicron new crown inactivated vaccine is expected to be available at the end of September. However, vaccination is only part of the epidemic prevention and control policy. It is not that you can sit back and relax after being vaccinated. As long as the virus still poses a threat to people’s health, it is necessary to continue to normalize epidemic prevention and control, and adhere to the dynamic reset policy.