[latest] the first edition of novel coronavirus vaccination technical guide is coming!

The first National Health Commission (National Health Commission) released the first edition of technical guidelines for vaccination of coronavirus

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It is pointed out that the applicable objects are people aged 18 and above

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Two doses of inactivated new coronavirus vaccine (Vero cells) should be injected

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The interval between the two doses should be more than 3 weeks

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The second dose should be completed as early as 8 weeks

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More information is provided below

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1、 Type of vaccine (1) inactivated vaccine

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The three new coronavirus inactivated vaccine products approved for marketing conditionally are respectively produced by Sinopharm Beijing Institute of Biological Products Co., Ltd

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(Beijing Institute), Wuhan Institute of Biological Products Co., Ltd

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(Wuhan Institute) and Beijing Kexing Zhongwei Biological Technology Co., Ltd

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(Kexing Zhongwei)

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The principle is to use Vero cells to culture and amplify the virus, inactivate the virus with β – propionolactone, retain antigen components to induce immune response, and add aluminum hydroxide adjuvant to improve immunogenicity

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(2) Adenovirus vector vaccine

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The new recombinant coronavirus vaccine (type 5 adenovirus vector) produced by kangxinuo biological Co., Ltd

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(kangxinuo) was approved to be listed conditionally

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The principle is to recombine the spike glycoprotein (s protein) gene of the new coronavirus into the replication deficient human adenovirus type 5 gene, and the recombinant adenovirus expresses the S protein antigen of the new coronavirus in vivo to induce immune response

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(3) Recombinant subunit vaccine

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The recombinant subunit vaccine approved for emergency use is the recombinant new coronavirus vaccine (CHO cell) produced by Anhui zhifeilongkema biopharmaceutical Co., Ltd

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(zhifeilongkema)

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The principle is to recombine the S protein receptor binding region (RBD) gene of new coronavirus into the gene of Chinese hamster ovary (CHO) cells, express it in vitro to form RBD dimer, and add aluminum hydroxide adjuvant to improve the immunogenicity

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2、 Recommended immunization program (1) applicable objects

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People aged 18 and above

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(2) Inoculation times and intervals

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1

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Two doses of new coronavirus inactivated vaccine (Vero cell) should be injected; the interval between the two doses should be more than 3 weeks, and the second dose should be completed as soon as possible within 8 weeks

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2

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One dose of recombinant new coronavirus vaccine (type 5 adenovirus vector)

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3

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Three doses of recombinant new coronavirus vaccine (CHO cells) were inoculated, and the interval between the two adjacent doses should be more than 4 weeks

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The second dose should be completed within 8 weeks after the first dose, and the third dose should be completed within 6 months after the first dose

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(3) The route and site of inoculation are recommended

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3、 (1) late replanting

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For those who fail to complete the vaccination according to the procedure for 2 or 3 doses of vaccine, it is recommended to re vaccinate as soon as possible

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There is no need to restart the immunization procedure, and the corresponding dose can be completed

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For those who have completed two doses of inactivated vaccine of new coronavirus within 14 days, one dose of inactivated vaccine should be given as soon as possible 3 weeks after the second dose

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There is no need to re vaccinate those who have completed two doses of inactivated coronavirus vaccine in 14-21 days

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(2) Strengthen immunization

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At present, it is not recommended to strengthen immunization

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(3) They were vaccinated at the same time as other vaccines

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It is not recommended to vaccinate with other vaccines at the same time

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The interval between other vaccines and new coronavirus vaccine should be more than 14 days

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When rabies vaccine, tetanus vaccine and immunoglobulin need to be vaccinated due to animal injury, trauma and other reasons, the vaccination interval with new coronavirus vaccine may not be considered

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(4) Replacement of different vaccine products

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At this stage, it is recommended to complete the vaccination with the same vaccine product

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In case that the vaccine cannot be supplied continuously and the recipient can not be inoculated in other places, the same vaccine product can be used to complete the vaccination

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(5) New coronavirus infection and antibody screening

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It is not necessary to detect the nucleic acid and antibody of new coronavirus before vaccination, and it is not recommended to detect the antibody after vaccination as the basis of successful immunization

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(6) vaccination contraindications

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The common contraindications of vaccination include: (1) people who are allergic to the active ingredients, any non active ingredients and substances used in the production process of the vaccine, or people who have been allergic to the same kind of vaccine before; (2) people who have had severe allergic reactions to the vaccine in the past (such as acute hypersensitivity, angioneurotic edema, dyspnea, etc.); (3) people who have uncontrolled epilepsy and other diseases Patients with severe nervous system diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.); (4) patients with fever, acute disease, acute attack of chronic disease, or uncontrolled severe chronic disease; (5) pregnant women

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This guideline refers to the following specific population vaccination recommendations for some people listed in the manual who are contraindicated or cautious in vaccination

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4、 Specific population vaccination recommendations (1) people aged 60 and above

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People over 60 years old are at high risk of severe and death after new coronavirus infection

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At present, the number of phase III clinical trials of four new coronavirus vaccines approved for marketing is limited, and there is no data on the protective effect of the vaccine on this population

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However, the data of phase I / II clinical study showed that the safety of vaccination in this population was good

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Compared with the population aged 18-59, the titer of neutralizing antibody after vaccination was slightly lower, but the positive conversion rate of neutralizing antibody was similar, suggesting that the vaccine would also have a certain protective effect on the population aged over 60, so vaccination is recommended

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(2) people under the age of 18

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At present, the existing vaccine has not yet obtained the clinical trial data for this population, so it is not recommended to vaccinate people under 18 years old

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(3) Chronic patients

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The chronic patients were severe and high risk of death after infection with new coronavirus

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The chronic patients with stable health and good drug control are not taboo population for new coronavirus vaccination, so vaccination is recommended

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(4) Women of childbearing age and lactation

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In case of pregnancy after vaccination or in case of unknown pregnancy, based on the understanding of the safety of the above vaccines, it is not recommended to take special medical measures (such as termination of pregnancy) just because of vaccination of new coronavirus vaccine, and it is recommended to do a good job in pregnancy examination and follow-up

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For women who have a pregnancy plan, it is not necessary to delay the pregnancy plan just because of the new coronavirus vaccine

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Although there is no clinical research data on the impact of new coronavirus vaccination on lactating infants among lactating women, based on the understanding of the safety of the vaccine, it is recommended to vaccinate lactating women (such as medical staff) with high risk of new coronavirus infection

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Considering the importance of breast-feeding to infant nutrition and health, referring to the international practice, it is suggested that breast-feeding should be continued after breast-feeding women are vaccinated with new coronavirus vaccine

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(5) People with impaired immune function

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People with impaired immune function are at high risk of severe and death after infection with new coronavirus

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At present, there is no data on the safety and effectiveness of the new coronavirus vaccine for this population (such as cancer, nephrotic syndrome, AIDS patients) and human immunodeficiency virus (HIV) infected people

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The immune response and protective effect of these people may be reduced after vaccination

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For inactivated vaccine and recombinant subunit vaccine, vaccination is recommended according to the safety characteristics of the same type of vaccine in the past; for adenovirus vector vaccine, although the vector virus used is replication defective, there is no safety data of the same type of vaccine in the past, vaccination is recommended after full notice that individual benefits outweigh risks

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(6) Patients with previous novel coronavirus or infection

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Existing research data show that the incidence of reinfection is rare within 6 months after new coronavirus infection

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Novel coronavirus pneumonia patients (patients or asymptomatic infections) were given 1 doses of antibiotics after 6 months.

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