Where is the R & D? Who needs emergency vaccination? Five questions and five answers of new coronal vaccine

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 Where is the R & D? Who needs emergency vaccination? Five questions and five answers of new coronal vaccine


The reporter interviewed authoritative organizations and professionals to answer the publics concerns about the new coronavirus vaccine.

Where has vaccine been developed?

The reporter learned from the joint prevention and control mechanism of the State Council that the international phase III clinical trials of four new coronavirus vaccines in China have been started, and some trials will complete the first round of vaccination in early September.

Yang Xiaoming, chairman of China Biotechnology Co., Ltd., introduced that the two new types of inactivated coronavirus vaccines developed by the company have been approved to carry out phase III clinical trials in many countries in the Middle East and South America, with a total number of more than 30000 people.

Yin Weidong, chairman of Beijing Kexing zhongweisheng Technology Co., Ltd., introduced that a new type of inactivated coronavirus vaccine developed by the enterprise is steadily promoting phase III clinical trials in several countries in South America and Southeast Asia.

Because the novel coronavirus pneumonia epidemic is effectively controlled in China, and the objective conditions for large-scale clinical trials are not available in China, the above phase III clinical trials are conducted overseas.

What are the characteristics of different vaccines?

According to Xu Jinghe, deputy director of the State Food and drug administration, five technical routes and 10 new coronavirus vaccines have been approved for clinical trials.

The four new coronavirus vaccines, which are expected to be the first to cross the end line of mass vaccination, belong to two technical routes: inactivated vaccine and adenovirus vaccine. The other three technical routes include recombinant protein vaccine, attenuated influenza virus vector vaccine and nucleic acid vaccine.

Among them, inactivated vaccine is a kind of vaccine that can kill the virus by physical or chemical methods, but still retain the activity of human immune response caused by the virus. The vaccine of this technical route has a long-term research basis.

In addition, the Institute of Microbiology, Chinese Academy of Sciences and Anhui zhifeilong Kema biopharmaceutical Co., Ltd. jointly developed the new coronal recombinant protein vaccine, which is now in phase II clinical trial, is to express and purify pathogen antigen protein in engineering cells by genetic engineering, and then prepare the vaccine.

According to reports, no matter which technical route of vaccine, strict monitoring and evaluation of safety and effectiveness will be put in the first place. On the premise of ensuring safety, effectiveness and scientific compliance, relevant enterprises will start large-scale vaccine production capacity.

Who is in emergency vaccination?

Novel coronavirus vaccine was approved by the State Council in June 24th, and the 2 vaccines were approved for emergency use, and the new crown virus vaccine was launched in July 22nd.

Article 20 of the vaccine administration law of the peoples Republic of China, which came into force on December 1, 2019, stipulates that in the event of a particularly serious public health emergency or other emergencies that seriously threaten public health, the health department under the State Council shall, according to the needs of prevention and control of infectious diseases, put forward suggestions for emergency use of vaccines, which shall be demonstrated and approved by the drug regulatory department under the State Council After that, it can be used in a certain range and within a certain period of time.

Who is in emergency vaccination? Zheng Zhongwei, director of the science and technology development center of the National Health Commission, said that according to relevant laws and regulations, emergency use (Trial) is limited to specific groups of people with high exposure risk and unable to use effective protective measures; people who use vaccines urgently should not be taken lightly, and other protective measures and means should not be reduced. In this way, the basic protection for the medical personnel in the city, such as vaccination and operation personnel, can be established.

In addition, it is reported that some overseas staff, as well as some medical staff and market staff, have also been urgently vaccinated with the new coronavirus inactivated vaccine.

How long can the vaccine last?

According to the results of phase I and phase II clinical trials, a number of new coronavirus vaccines showed good safety and antibody effectiveness.

Yang Xiaoming introduced that the two vaccines of China biology were successively approved in April, and the phase I and phase II clinical trials were launched. The results showed that the positive conversion rate of neutralizing antibody reached 100% after the two doses of vaccines were inoculated.

How long can these antibodies last? The answer remains to be confirmed in phase III clinical trials.

At the same time, a group of researchers are collecting the data of cases infected with new coronavirus and recovering during the outbreak of domestic epidemic, analyzing the duration of antibody in vivo, and trying to answer the question of whether new coronavirus will be re infected from the mechanism.

The novel coronavirus vaccine preventive evaluation guidelines (Trial Implementation) issued recently by the national drug regulatory agencys drug review center issued a special recommendation for the effectiveness of the new crown virus vaccine: the vaccine should provide protection for 1 years or more, and provide at least 6 months of protection. Is the new coronavirus vaccine and influenza vaccine superimposed? It is reported that the new coronavirus vaccine is expected to achieve two in one with the influenza vaccine in the current season in the future, so as to simplify the vaccination process. But before the novel coronavirus pneumonia vaccine was approved, many experts called for more efforts to vaccinated the flu vaccine so as not to form a superposition of new crown pneumonia and influenza. Chinas novel coronavirus pneumonia once merged with the flu, the differential diagnosis will be very difficult. The difficulty of isolation will increase significantly and the input of social resources will also increase significantly, Wang Chen, President of the Beijing Union Medical College of Chinese Academy of Medical Sciences, said. The most effective way is to get a universal influenza vaccination in time. Wang Chen said. Source: editor in charge of Xinhua News Agency: Ding Guangsheng_ NT1941

The novel coronavirus vaccine preventive evaluation guidelines (Trial Implementation) issued recently by the national drug regulatory agencys drug review center issued a special recommendation for the effectiveness of the new crown virus vaccine: the vaccine should provide protection for 1 years or more, and provide at least 6 months of protection.

Is the new coronavirus vaccine and influenza vaccine superimposed?

It is reported that the new coronavirus vaccine is expected to achieve two in one with the influenza vaccine in the current season in the future, so as to simplify the vaccination process.

But before the novel coronavirus pneumonia vaccine was approved, many experts called for more efforts to vaccinated the flu vaccine so as not to form a superposition of new crown pneumonia and influenza.

Chinas novel coronavirus pneumonia once merged with the flu, the differential diagnosis will be very difficult. The difficulty of isolation will increase significantly and the input of social resources will also increase significantly, Wang Chen, President of the Beijing Union Medical College of Chinese Academy of Medical Sciences, said.