On April 26, Sinopharm's Inactivated COVID-19 vaccine of China Biological Aomi Kerong Mutant Strain (hereinafter referred to as "Aobu") was clinically approved by the State Food and Drug Administration.
When will the Olympus vaccine be available? In the face of the situation that There are more mild diseases in Olmiqueron, is it still necessary to vaccinate the Olympus? Is the production capacity supply of Aobu vaccine guaranteed? Will the public need new vaccines every year to prevent COVID-19 infections?
On April 27, Sinopharm China Biologics held a media communication meeting on "Clinical Approval of the New Coronavirus Inactivated Vaccine of the Aomi Kerong Variant Strain". In response to the questions raised by reporters, Zhang Yuntao, chief scientist and vice president of China Biology, and Yang Huichuan, chief scientist and vice president of China Biology, answered the questions and responded to the hot spots.
The previous generation of COVID-19 vaccines remains effective
A few days ago, Sinopharm's Inactivated Covid-19 vaccine of TheOpharm China Bio-Aumi Kerong Variant has received clinical approval from Hong Kong and the mainland.
Zhang Yuntao said that China Biologics is accelerating the relevant clinical research work, and the clinical plan of the vaccine should be determined after discussion with experts and drug regulatory departments. At present, clinical research will take about 3 to 4 months to complete.
"The Ao strain vaccine is not a complete negation of the previous new crown vaccine, and the generation of new crown vaccines vaccinated in the early stage is still effective, especially for the prevention of severe illness and death for people over 60 years old, which has obvious efficacy." Zhang Yuntao stressed to reporters that the current vaccination of the Olympic vaccine, from the perspective of clinical design, is not designed according to four injections, but on the basis of the completion of two or three injections of the inactivated vaccine in the early stage, the vaccination research of the Austrian vaccine is carried out.
Clinical research is planned in two routes
Does this mean that people who have not been vaccinated against COVID-19 cannot be vaccinated against the Olympian vaccine? Zhang Yuntao explained that the clinical study of the Opmi Kerong new crown inactivated vaccine is currently planned to be carried out along two routes. One route is to have received two or three doses of inactivated vaccines in the early stages, with an interval of three or six months, and then inject vaccines against the Omikejung variant, respectively, for safety and immunogenicity observation. In addition, studies will be carried out simultaneously in the blank population to observe the safety and immunogenicity of the New Coronavirus vaccine of the Semikron variant.
Zhang Yuntao said that in response to the Aomi Kerong variant, in addition to the inactivated vaccine, China Biology also has a new generation of recombinant vaccines and mRNA vaccines, which are all submitting information to the drug regulatory department on a rolling basis and are in the final sprint stage.
Vaccination with the Olympian vaccine prevents latent infection
Some people believe that Aomi Kerong has more mild diseases, and the need for vaccination is affected? Is there a problem with vaccine hesitation? In this regard, Zhang Yuntao said that the Omiljung virus spreads rapidly and violently, and nearly half of the recent mass infections in the mainland are due to the spread of hidden infections and then cause cluster infections. "Vaccination with the Olympic strain vaccine will significantly improve the efficacy of preventing mild diseases and preventing hidden infections, so vaccination is necessary!"
Does the public need a new vaccine every year to prevent COVID-19 infection? Zhang Yuntao said that whether a new COVID-19 vaccine needs to be developed depends on the span of virus mutation. "The so-called span size, from the protective effect of the vaccine, is mainly the result of immunogenicity, that is, the protective result of serology, which is the most important criterion for judging."
"This time the prototype virus to the Aumecreon variant strain, is the prototype strain of the new crown vaccine produced antibodies, the neutralization activity of the Omicron significantly reduced, the span is large, the need to develop a new vaccine." Zhang Yuntao said that if the neutralizing antibody produced by the prototype strain of the new crown vaccine still has a good neutralizing effect on the mutant strain, the span is relatively small, from the perspective of vaccine protection, then there is no need to develop a new vaccine.
For the issue of whether the elderly and children, who have attracted much attention from the outside world, can be vaccinated against the Austrian strain, Zhang Yuntao said that the current clinical research will first be carried out for people over 18 years old, and follow-up clinical research will be accelerated for people aged 3 to 17 years old and infants and young children. After obtaining the data, this part of the population can also be vaccinated.
"The contraindications to the Ao-strain vaccine and the contraindications to the first-generation inactivated vaccine are completely consistent, and there are no other special matters. Corresponding clinical studies have been carried out for diabetes, hypertension, AIDS and other populations, and the contraindications will gradually decrease in the future. Zhang Yuntao said.
Future clinical studies will focus most on neutralizing antibodies
Compared with the inactivated COVID-19 vaccines that have been listed, what are the difficulties in the development of the Semikron inactivated COVID-19 vaccines? Zhang Yuntao said that the overall research and development route of the Austrian vaccine is consistent with the inactivated vaccine of a generation, and the process is basically the same, but because of the concept of replacing the strain to develop, the quantitative detection of antigens and the change of viral culture titer are new problems facing clinical research.
The reporter learned that in the process of future clinical research, the most important thing to pay attention to is whether the Austrian vaccine can produce neutralizing antibodies specific to the Aumechjong virus strain. "This is the core issue of effectiveness." Zhang Yuntao said. In addition, whether the Vaccine has improved the immunogenicity of variants such as prototype viruses or Delta also needs to be continuously observed during clinical research.
After the listing is approved, the supply of production capacity is guaranteed
Talking about the production of Aomi Kerong's new crown inactivated vaccine, Yang Huichuan said that since the epidemic, China Biologics has launched the research and development of new crown vaccines and workshop construction, and has built 3 P3 high-grade biosafety laboratories and 6 P3 high-grade biosafety workshops across the country, with an annual production capacity of more than 7 billion doses. "During the development of the new Omilon inactivated COVID-19 vaccine, the main production process and quality testing methods have basically not changed. These production facilities originally built by China Biotech, including the supporting sub-packaging, can be continued to be used. ”
At the same time, Yang Huichuan said that Sinopharm China has also made full preparations, including raw materials and bottles and packaging materials used in the Olympic vaccine, "After being approved in the future, it will be fully put into production, and there is no problem in terms of production capacity and supply guarantee." ”
What makes the outside world feel happy is that compared with the original first-generation vaccine, the research and development speed of the Austrian vaccine has been greatly improved.
"With the gradual maturity of the construction of the emergency response system for sudden infectious diseases in the mainland, relying on the vaccine research and development technology innovation platform, if new sudden infectious diseases are encountered, the research and development process will be shortened." Zhang Yuntao said.