"Mixed" antibodies 10 times higher? Does dealing with Ami kerong require "scuffle"?

According to media reports, the test results released by the China Institute of Food and Drug Control (hereinafter referred to as the "China Academy of Food and Drug Control") show that after receiving 2 doses of inactivated vaccine, the 1 dose of adenovirus vector new crown vaccine (inhalation dosage form) was sequentially strengthened, and the neutralizing antibody titer of the pseudovirus of the Omikejong variant was only slightly lower than that of the prototype strain, and the neutralizing antibody titer was 10 times higher than that of the three-shot inactivated vaccine.

A long list of technical terms such as "fake virus", "prototype strain", "slight decline", etc., brings a lot of dyslexia.

In short, it is the "2+1" "mixed hit" that produces antibodies, which are tested on the fake virus of Omi kerong, and it is effective! May be more effective than 3-needle inactivation.

Image source: Visual China

The question is, why experiment with a fake virus from Omicron? 2+1 mixing may be more effective, should I turn on mixed play?

Why use a "fake virus" test? Are the results reliable?

Before the first imported case carrying the Aumecreon strain entered the country, no Aumikejun strain was found in China.

What if there is no Aomi Kerong strain and scientific research is still necessary?

As a national platform, China Inspection has long established a technical support platform for independent intellectual property rights. The pseudoviruses are used to form the Pseudovirus of Omikejong by site-directed mutations for preliminary research on the effect of vaccines.

With the pseudo-virus technology, Ami kerong can initially explore the effectiveness of the vaccine before coming. In the "Technical Guidelines for the Research and Development of Vaccines for Novel Coronavirus Prevention (Trial)" issued by the State Food and Drug Administration, it is specifically mentioned that the preliminary immunogenicity exploration can carry out the "pseudoviral neutralization method" to determine the antibody titer, but the results of this method need to be compared with the results of traditional methods or animal poison tests, and further verification should be followed.

It can be seen that the official guidelines believe that the results of the fake virus are preliminary and still need to be verified subsequently.

This time, the fake virus technology platform has reached a "mixed- beating" antibody 10 times higher, and it still needs to be verified by the subsequent real Omikejong strain and even animal tests.

As of press time, there have been cases of Aumecreon infection in two places in China, and relevant departments are further carrying out follow-up research after obtaining the Aomi kerong strain.

According to the data, the Chinese Center for Disease Control and Prevention, Sinopharm Group and Kexing Bio have received the Aomi Kerong strain isolated from the University of Hong Kong around December 9, and have carried out virus culture and vaccine research and development.

Is "mixed-up" ok?

Regarding the "mixed beating", the reporter of Science and Technology Daily summed up the views from three aspects -

For its part, the World Health Organization has convened a meeting of the Strategic Advisory Group on Immunization to make corresponding recommendations on the use of polio vaccine, influenza vaccine, malaria vaccine and NEW CROWN vaccine. In terms of strengthening immunization with covid-19 vaccines, they suggested the use of homologous vaccines, that is, vaccines with the same technical route; they also discussed the issue of sequential immunization of different technical routes of new crown vaccines, believing that there must be evidence and corresponding research results.

Wang Huaqing, chief expert of the immunization program of the Chinese Center for Disease Control and Prevention, said at the previous press conference of the joint prevention and control mechanism that the current advice given by experts is to use the vaccine produced by the original vaccination enterprise, and if the same enterprise cannot meet the supply, it is also necessary to choose the same technical route of the vaccine for vaccination.

Zhang Yuntao, chief scientist of Sinopharm China Biologics, told Science and Technology Daily that from the perspective of scientific research and innovation, the state actively supports and encourages the development of "mixed-up" research work. China Biologics has carried out the research and development of a number of vaccines including protein recombinant, mRNA and other technical routes, and has also carried out research work on the effect of "mixed play" between vaccines of different technical routes. If the vaccine is "mixed" in a large number of people, it needs to follow the scientific rules.

What research should be done before "mixing"?

Relevant experts said that based on the current policies and regulations, mixed vaccines must be vaccines that have been approved for marketing or obtained emergency marketing authorization. The effect of mixing should be evaluated on sensitive animals and should not be limited to the results of neutralizing antibody titers. The safety of mixed beatings must be evaluated and validated on a qualified GLP (Good Practice for Non-Clinical Studies of Drugs) platform.

Therefore, the mixed play still needs further scientific research to verify. Wang Huaqing also said earlier, "The follow-up will be based on the sequential immunization results of the relevant enterprise research to demonstrate and put forward relevant suggestions." ”

Vaccine products have strict specifications in terms of marketing and use strategies and indications, which need to be strictly implemented according to the requirements of the State Food and Drug Administration when approving the application. If the implementation of "mixed beating", it is necessary to submit materials, submit an application, be approved for listing after review and approval, or obtain an emergency use permit from the relevant department.

To deal with Omi kerong, do you need to "mix"?

For the mutant strain, China's vaccine research and development units have always continued to track, intervene in advance, and carry out research.

Xu Wenbo, director of the Institute of Viral Disease Prevention and Control of the Chinese Center for Disease Control and Prevention, said at the press conference of the joint prevention and control mechanism of the State Council that China has done a good job in the preliminary technical reserves and research of many technical routes including inactivated vaccines, protein vaccines, carrier vaccines and other technical routes for the Omilkerong variant, and the relevant preliminary design of some enterprises has begun.

"When a new large-scale epidemic variant strain appears, we will use a mature and complete technical system, that is, an emergency research and development and production system for emerging infectious diseases, and quickly complete the development of a new inactivated vaccine to deal with the mutant strain." Zhang Yuntao told science and technology daily reporter that all the research work before the clinical trial can be completed in about 2 months.

Whether the efficiency of existing vaccines will be reduced due to the increased immune escape capacity of Omi kerong remains to be further confirmed, and further evaluation of which strategy will be used once escaped needs to be further evaluated.

At present, the safety of "mixed beating" still needs to be further verified, and the development of a new crown vaccine specifically for Aumicron has a short cycle. Is it "mixed-up" or a new vaccine? The relevant departments will judge based on "maximum protection at the least cost".

Source Science and Technology Daily WeChat public account

Edited by Li Tuo

Process Editor Yan Shengmiao