On April 26, Sinopharm China Bio-Omicoron variant strain (hereinafter referred to as "Austrian strain") new coronavirus inactivated vaccine received clinical approval from the State Food and Drug Administration.
When will the Austrian strain vaccine be available?
In the face of more mild cases of Omicron, is it necessary to vaccinate the Austrian strain?
Is the production capacity and supply of the Austrian strain vaccine guaranteed?
Will the public need to be vaccinated every year to prevent new crown infections in the future?
On April 27, Sinopharm Group China Biology held a media communication meeting on "Clinical Approval for New Crown Inactivated Vaccine of Omicron Variant".
In response to the questions raised by reporters, Zhang Yuntao, Chief Scientist and Vice President of China Biotechnology, and Yang Huichuan, Chief Scientist and Vice President of China Biotechnology, answered the questions.
A generation of new crown vaccines vaccinated earlier is still effective
A few days ago, Sinopharm Group's China Bio-Omicron variant of the new coronavirus inactivated vaccine has successively obtained clinical approvals from Hong Kong and the mainland.
Zhang Yuntao said that Sino Bio is accelerating relevant clinical research work, and the clinical plan of the vaccine must be determined after discussions with experts and drug regulatory authorities.
At present, clinical studies still need about 3 to 4 months to complete.
"The Austrian strain vaccine is not a complete denial of the previous new crown vaccine. The first generation of new crown vaccines vaccinated in the early stage is still effective, especially for people over 60 years old to prevent severe illness and prevent death. It has obvious curative effect." Zhang Yuntao emphasized to reporters that at present From the perspective of clinical design, the vaccination of the Austrian strain vaccine 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 inoculation research of the Austrian strain vaccine is carried out.
Clinical research divided into two lines as planned
Does this mean that people who have not been vaccinated against the new crown cannot be vaccinated against the Austrian strain?
Zhang Yuntao explained that the clinical research of Omicron’s new crown inactivated vaccine is currently planned to be carried out according to two routes.
One route is to have received two or three doses of inactivated vaccine in the early stage, with three or six months apart, and then inject the vaccine against the Omicron variant to observe the safety and immunogenicity.
In addition, research will be carried out simultaneously in blank populations to observe the safety and immunogenicity of the new crown vaccine of the Omicron variant.
Zhang Yuntao said that for the Omicron variant, in addition to inactivated vaccines, China Biotech also has a new generation of recombinant vaccines and mRNA vaccines, all of which are rolling out submissions to the drug regulatory department and are in the final sprint stage.
Vaccination with Austrian strain prevents latent infection
Some people think that Omicron has more mild symptoms, so is the necessity of vaccination affected?
Will there be a problem of vaccine hesitancy?
In this regard, Zhang Yuntao said that the Omikron virus spreads rapidly and violently. Nearly half of the group infections in my country recently were caused by the spread of recessive infections and then clustered infections.
"Inoculation of the Austrian strain vaccine will significantly improve the efficacy of preventing mild onset and latent infection, so vaccination is necessary!"
Does the public need a new vaccine every year to protect against Covid-19?
Zhang Yuntao said that whether a new coronavirus vaccine needs to be developed depends on the span of virus mutation.
"The so-called span, in terms of the protective effect of the vaccine, is mainly the result of immunogenicity, that is, the result of serological protection, which is the most important criterion."
"This time, the mutant strain of the prototype virus to Omicron is the antibody produced by the prototype strain of the new crown vaccine. The neutralizing activity of Omicron has dropped significantly, and the span is large, so new vaccines need to be developed." Zhang Yuntao said, If the neutralizing antibody produced by the prototype strain of the new crown vaccine still has a good neutralizing effect on the variant strain, the span is relatively small. From the perspective of vaccine protection, then there is no need to develop a new vaccine.
Regarding the issue of whether the elderly and children can be vaccinated with the Austrian strain vaccine, which has attracted much attention from the outside world, Zhang Yuntao said that the current clinical research will first be carried out for people over 18 years old, and the follow-up will be accelerated for people aged 3 to 17 years old and infants and young children. clinical research.
After the data is obtained, this part of the population can also be vaccinated.
"The contraindications of the Austrian strain vaccine are exactly the same as those of the first-generation inactivated vaccine, and there are no other special matters. Corresponding clinical studies have been carried out for people with diabetes, hypertension, AIDS, etc., and future contraindications It will gradually decrease." Zhang Yuntao said.
Neutralizing antibodies will be most focused on future clinical research
Compared with the marketed new crown inactivated vaccine, what are the difficulties in the development of the new crown inactivated vaccine of Omicron?
Zhang Yuntao said that the overall research and development route of the Austrian strain vaccine is consistent with that of the first-generation inactivated vaccine, and the process is generally the same. It is a new problem faced by 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 strain vaccine can produce neutralizing antibodies specific to the Omicron virus strain.
"This is the core issue of effectiveness." Zhang Yuntao said.
In addition, whether the immunogenicity of the Austrian strain vaccine to the prototype virus or delta strains has also improved, it also needs to be continuously observed during the clinical research process.
After the listing is approved, the production capacity supply is guaranteed
Talking about the production of Omicron's new crown inactivated vaccine, Yang Huichuan said that since the epidemic, China Biotechnology has launched the research and development and workshop construction of the new crown vaccine, and has built 3 P3 high-level biosafety laboratories and 6 laboratories across the country. P3 high-level biosafety production workshop, with an annual production capacity of more than 7 billion doses.
"During the research and development of the new Omicron COVID-19 inactivated vaccine, the main production process and quality testing methods have basically remained unchanged. These production facilities originally built by China Biotechnology, including the supporting sub-packaging, can continue to be used."
At the same time, Yang Huichuan said that Sinopharm China has also made full preparations, including the raw materials, bottles, and packaging materials used in the Ao-strain vaccine, "after approval in the future, we will fully invest in production, and there will be no problems with production capacity and supply guarantees. "
To the delight of the outside world, compared with the original first-generation vaccine, the development speed of the Austrian strain vaccine has been greatly improved.
"As the construction of my country's emergency response system for sudden infectious diseases gradually matures, relying on the scientific and technological innovation platform for vaccine research and development, if new sudden infectious diseases are encountered again, the research and development process will definitely be shortened." Zhang Yuntao said.
Reporter Yuan Lu