At present, COVID-19 vaccines from five manufacturers in China have been approved for conditional marketing or emergency use. The mid-term analysis of three kinds of inactivated vaccines and adenovirus vector vaccines that have been approved for marketing shows that the protective efficacy of the vaccines meets the requirements of the Guiding Principles for Clinical Evaluation of Preventive Vaccines in novel coronavirus issued by the State Administration of Medical Supplies, and also meets the index requirements recommended by the World Health Organization's COVID-19 Vaccine Target Product Characteristics. Clinical trials, emergency use stage and monitoring data of abnormal reaction of suspected vaccination in large-scale vaccination of key population in early stage show that the safety of COVID-19 vaccine is good. The second phase clinical trial of recombinant COVID-19 vaccine approved for emergency use shows that it has good immunogenicity and safety.
According to the clinical trial data of approved vaccines in China and the epidemiological characteristics of COVID-19, the COVID-19 Vaccine Working Group of China Center for Disease Control and Prevention drafted this guideline, which was reviewed and approved by the National Advisory Committee of Immunization Planning Experts.
This guide is for health departments and disease control institutions at all levels in COVID-19 to guide vaccination units to carry out vaccination work. _
I. Types of vaccines
Inactivated vaccine.
Three kinds of qualified COVID-19 inactivated vaccine products approved for marketing were produced by China Bio-Beijing Institute of Biological Products, Wuhan Institute of Biological Products and Beijing Kexing Zhongwei Biotechnology Co., Ltd., respectively. The principle is to use African green monkey kidney cells to culture and amplify the virus, inactivate the virus with β-propiolactone, retain antigen components to induce immune response, and add aluminum hydroxide adjuvant to improve immunogenicity.
Adenovirus vector vaccine.
Conditionally approved adenovirus vector vaccine is a recombinant COVID-19 vaccine produced by Kangxinuo Bio-stock Company. Its principle is to recombine novel coronavirus spike glycoprotein gene into replication-deficient human adenovirus type 5 gene, and the recombinant adenovirus expresses COVID-19 S protein antigen in vivo to induce immune response.
Recombinant subunit vaccine.
The recombinant subunit vaccine approved for emergency use this time is the recombinant COVID-19 vaccine produced by Anhui Zhifeilong Kyle Biopharmaceutical Co., Ltd. Its principle is to recombine the new coronavirus S protein receptor binding region gene into China hamster ovary gene, express it in vitro to form RBD dimer, and add aluminum hydroxide adjuvant to improve immunogenicity.
Second, the recommended immunization program
Applicable object.
18 years old and above.
Vaccination time and interval.
1. COVID-19 inactivated vaccine.
Inoculate 2 doses; The interval between two doses of inoculation is recommended to be ≥3 weeks, and the second dose should be completed as soon as possible within 8 weeks.
2. Recombinant COVID-19 vaccine
Inoculation 1 dose.
3. Recombinant COVID-19 vaccine
Inoculate 3 doses; The interval between two adjacent doses is recommended to be ≥4 weeks. The second dose should be completed within 8 weeks after 1 dose, and the third dose should be completed within 6 months after 1 dose.
Inoculation route and inoculation site
It is recommended to inject the deltoid muscle of the upper arm.
Three. Other related matters.
Later planting and replanting.
For 2 or 3 doses of vaccine, if the vaccination is not completed according to the procedure, it is recommended to replant as soon as possible. There is no need to restart the immunization program, just replant and complete the corresponding dose.
For those who have completed 2 doses of inactivated vaccine in COVID-19 within 14 days, they should replant 1 dose of inactivated vaccine as soon as possible within 3 weeks after the second dose. If two doses of inactivated COVID-19 vaccine are inoculated within 14-2 1 day, there is no need to replant.
Enhance immunity.
Strengthening immunization is not recommended at this stage.
Inoculate at the same time as other vaccines.
Simultaneous vaccination with other vaccines is not recommended for the time being. The vaccination interval between other vaccines and COVID-19 vaccine should be greater than 14 days. When rabies vaccine, tetanus vaccine and immunoglobulin need to be vaccinated due to animal injury, trauma and other reasons, the vaccination interval with COVID-19 vaccine may not be considered.
Replacement of different vaccine products.
At this stage, it is recommended to use the same vaccine product to complete vaccination. In case of special circumstances, such as the vaccine can't continue to be supplied, and the recipients can't use the same vaccine product to complete the vaccination, they can use the vaccine products of other similar manufacturers to complete the vaccination.
Infection and antibody screening in COVID-19.
COVID-19 nucleic acid and antibody tests are not required before vaccination; Routine antibody detection after vaccination is not recommended as the basis of successful immunization. _
Inoculation taboo.
The usual taboos of vaccination include: those who are allergic to the active ingredients of the vaccine, any inactive ingredients, substances used in the production process, or those who have been allergic to similar vaccines before; Those who have had severe allergic reactions to vaccines in the past; Uncontrolled epilepsy and other patients with serious nervous system diseases; Patients with fever, acute disease, acute attack of chronic disease or uncontrolled serious chronic disease; Pregnant women.
This guide refers to the following vaccination recommendations for specific populations that are contraindicated or used with caution in the instructions.
Four. Vaccination advice for specific population
People aged 60 and over.
People aged 60 and over are at high risk of serious illness and death after being infected with COVID-19 virus. At present, the number of four phase III clinical trials of COVID-19 vaccine approved for marketing is limited, and there is no data on the protective effect of the vaccine on this population. However, the data of phase I/II clinical research show that the vaccination safety of this population is good. Compared with the population aged 65,438+08-59, the titer of neutralizing antibody was slightly lower after inoculation, but the positive conversion rate of neutralizing antibody was similar, suggesting that the vaccine will also have some protection for people over 60 years old. Vaccination is recommended. _
/kloc-people under 0/8 years old.
At present, the existing vaccine has not obtained the clinical trial data for this population, so it is not recommended to vaccinate people below 18 for the time being.
Patients with chronic diseases.
People with chronic diseases are at high risk of serious illness and death after being infected with COVID-19 virus. Patients with chronic diseases with stable health and good drug control should not be regarded as taboo population for vaccination in COVID-19, so vaccination is recommended.
Women of childbearing age and lactation.
If you get pregnant after vaccination or get vaccinated in an unknown pregnancy situation, based on the understanding of the safety of the above vaccines, it is not recommended to take special medical measures only because of COVID-19 vaccine, and it is recommended to do a good job in pregnancy examination and follow-up. There is no need for a woman who has a pregnancy plan to postpone her pregnancy plan just because she has been vaccinated with COVID-19 vaccine.
Although there is no clinical research data on the effect of COVID-19 vaccine on lactating infants, based on the understanding of vaccine safety, it is suggested to vaccinate lactating women who are at high risk of infection in COVID-19. Considering the importance of breast-feeding to infant nutrition and health, and referring to international practice, it is recommended that breast-feeding women continue breast-feeding after receiving COVID-19 vaccine.
People with impaired immune function.
People with impaired immune function are at high risk of serious illness and death after infection in COVID-19. At present, there is no data on the safety and effectiveness of COVID-19 vaccine for this population and HIV-infected people. The immune response and protective effect of this part of the population may be reduced after vaccination. For inactivated vaccine and recombinant subunit vaccine, according to the safety characteristics of the same type of vaccine in the past, vaccination is recommended; For adenovirus vector vaccine, although the vector virus used is replication deficient, there is no safety data of the same type of vaccine in the past. It is suggested that the benefits outweigh the risks before vaccination.
Previous COVID-19 patients or infected persons.
Existing research data show that reinfection within 6 months after infection is rare in COVID-19. People who have been infected with COVID-19 virus in the past can be vaccinated with 1 dose after 6 months on the basis of full notification.
Verb (abbreviation for verb) Other matters
With the approval of more COVID-19 vaccines, the continuous improvement of vaccine clinical research data and the increase of post-marketing monitoring and evaluation data of vaccines, this guide will be updated according to the needs of epidemic prevention and control situation.