New Coronavirus Vaccination Technical Guide (First Edition)

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6pt;font-family:"Times New Roman";font-size:16pt;'> At present, China has already approved the conditional listing or emergency use of new coronavirus vaccines from five manufacturing companies.

At present, China has already approved the conditional listing or emergency use of new coronavirus vaccines from five manufacturing companies.

6pt;font-family:"Times New Roman";font-size:16pt;'> Based on the clinical trial research data of China's approved vaccines and the epidemiological characteristics of new coronary pneumonia , the New Coronavirus Vaccine Working Group of the Chinese Center for Disease Control and Prevention drafted this guideline, which was reviewed and approved by the Expert Advisory Committee of the National Immunization Program.

Based on the clinical trial research data of China's approved vaccines and the epidemiological characteristics of new coronary pneumonia , the New Coronavirus Vaccine Working Group of the Chinese Center for Disease Control and Prevention drafted this guideline, which was reviewed and approved by the Expert Advisory Committee of the National Immunization Program.

6pt;font-family:"Times New Roman";font-size:16pt;'> This guide is used by health departments and disease control agencies at all levels to guide vaccination units to carry out new coronavirus vaccination.

This guide is used by health departments and disease control agencies at all levels to guide vaccination units to carry out new coronavirus vaccination.

6pt;font-family:"Times New Roman";font-size:16pt;'> 1.

1.

6pt;font-family:"Times New Roman";font-size:16pt;'> (1) Inactivated vaccines.

(1) Inactivated vaccines.

6pt;font-family:"Times New Roman";font-size:16pt;'> The three new coronavirus inactivated vaccine products approved for listing with conditions are provided by Sinopharm China National Bio-Beijing Institute of Biological Products Co.

The three new coronavirus inactivated vaccine products approved for listing with conditions are provided by Sinopharm China National Bio-Beijing Institute of Biological Products Co.

6pt;font-family:"Times New Roman";font-size:16pt;'> (2) Adenovirus vector vaccine.

(2) Adenovirus vector vaccine.

6pt;font-family:"Times New Roman";font-size:16pt;'> The adenovirus vector vaccine approved for marketing with conditions is a recombinant new coronavirus vaccine ( type 5 adenovirus vector) produced by Cansino Biotech Co.

The adenovirus vector vaccine approved for marketing with conditions is a recombinant new coronavirus vaccine ( type 5 adenovirus vector) produced by Cansino Biotech Co.

6pt;font-family:"Times New Roman";font-size:16pt;'> (3) Recombinant subunit vaccine.

(3) Recombinant subunit vaccine.

6pt;font-family:"Times New Roman";font-size:16pt;'> The recombinant subunit vaccine approved for emergency use is the recombinant new coronavirus vaccine ( CHO cell) produced by Anhui Zhifeilongkoma Biopharmaceutical Co.
, Ltd.
(Zhifeilongkoma ).
The principle is to recombine the new coronavirus S protein receptor binding region (RBD) gene into Chinese hamster ovary (CHO) cell genes, express in vitro to form RBD dimer, and add aluminum hydroxide adjuvant to improve immunogenicity .

The recombinant subunit vaccine approved for emergency use is the recombinant new coronavirus vaccine ( CHO cell) produced by Anhui Zhifeilongkoma Biopharmaceutical Co.
, Ltd.
(Zhifeilongkoma ).
The principle is to recombine the new coronavirus S protein receptor binding region (RBD) gene into Chinese hamster ovary (CHO) cell genes, express in vitro to form RBD dimer, and add aluminum hydroxide adjuvant to improve immunogenicity .
The recombinant subunit vaccine approved for emergency use is the recombinant new coronavirus vaccine ( CHO cell) produced by Anhui Zhifeilongkoma Biopharmaceutical Co.
, Ltd.
(Zhifeilongkoma ).
The principle is to recombine the new coronavirus S protein receptor binding region (RBD) gene into Chinese hamster ovary (CHO) cell genes, express in vitro to form RBD dimer, and add aluminum hydroxide adjuvant to improve immunogenicity .

6pt;font-family:"Times New Roman";font-size:16pt;'> 2.
Recommended immunization program

2.
Recommended immunization program

6pt;font-family:"Times New Roman";font-size:16pt;'> (1) Applicable objects.

(1) Applicable objects.

6pt;font-family:"Times New Roman";font-size:16pt;'> People who are 18 years old and above.

People who are 18 years old and above.

6pt;font-family:"Times New Roman";font-size:16pt;'> (2) Times and intervals of inoculation doses.

(2) Times and intervals of inoculation doses.

6pt;font-family:"Times New Roman";font-size:16pt;'> 1.
New coronavirus inactivated vaccine (Vero cells)

1.
New coronavirus inactivated vaccine (Vero cells)

6pt;font-family:"Times New Roman";font-size:16pt;'> Inoculate 2 doses; the recommended interval between the 2 doses is ≥ 3 weeks, and the second dose should be completed as soon as possible within 8 weeks.

Inoculated 2; vaccination is recommended interval between the two ≥ inoculated 2; recommended interval between vaccination ≥ 2 .
3 weeks, 2 weeks early completion 8.
Week, the second dose was completed as soon as possible within 8 weeks.

6pt;font-family:"Times New Roman";font-size:16pt;'> 2.
Recombinant new coronavirus vaccine ( type 5 adenovirus vector)

2.
Recombinant new coronavirus vaccine ( type 5 adenovirus vector) 2.
Recombinant new coronavirus vaccine ( type 5 adenovirus vector)

6pt;font-family:"Times New Roman";font-size:16pt;'> Inoculate 1 dose.

Inoculate 1 dose.
Inoculate 1 dose.

6pt;font-family:"Times New Roman";font-size:16pt;'> 3.
Recombinant new coronavirus vaccine (CHO cells)

3.
Recombinant new coronavirus vaccine (CHO cells)

6pt;font-family:"Times New Roman";font-size:16pt;'> Inoculate 3 doses; the recommended interval between two adjacent doses is ≥4 weeks.
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 .

Inoculate 3 doses; the recommended interval between two adjacent doses is ≥4 weeks.
For the second dose, try to inoculate 3 doses after the first dose; the interval between two adjacent doses is recommended to be ≥4 weeks.
The second dose should be completed within 8 weeks after the first dose , the third dose should be completed within a week after the first dose , and the third dose should be completed within 6 months after the first dose .

6pt;font-family:"Times New Roman";font-size:16pt;'> (3) Vaccination route and location

(3) Vaccination route and location

6pt;font-family:"Times New Roman";font-size:16pt;'> Intramuscular injection in the deltoid muscle of the upper arm is recommended.

Intramuscular injection in the deltoid muscle of the upper arm is recommended.

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Other related matters

3.
Other related matters

6pt;font-family:"Times New Roman";font-size:16pt;'> (1) Late planting and replanting.

(1) Late planting and replanting.

6pt;font-family:"Times New Roman";font-size:16pt;'> For the two-dose or three-dose program, if the vaccination is not completed according to the program, it is recommended to replant as soon as possible.
The immunization program does not need to be restarted, just complete the corresponding doses.

For the two-dose or three-dose program, if the vaccination is not completed according to the program, it is recommended to replant as soon as possible.
The immunization program does not need to be restarted, just complete the corresponding doses.
For the two-dose or three-dose program, if the vaccination is not completed according to the program, it is recommended to replant as soon as possible.
The immunization program does not need to be restarted, just complete the corresponding doses.

6pt;font-family:"Times New Roman";font-size:16pt;'> For those who have completed 2 doses of inactivated new coronavirus vaccination within 14 days, one dose of inactivated vaccine should be supplemented as soon as possible three weeks after the second dose of vaccination .
Pair 14-2 1 complete day two new crown inactivated virus vaccine, without the need to replant.

For the completion of two new crown inactivated virus vaccine recipients within 14 days, the first two inoculation of the two new crown inactivated virus vaccine recipients completed within 14 days, the first two vaccination 3 weeks after replant as soon as possible an inactivated vaccine.
One dose of inactivated vaccine should be supplemented as soon as possible after 14-2 weeks .
Pair 14-2 1 complete day two new crown inactivated virus vaccine, without the need to replant.
If you complete 2 doses of inactivated COVID-19 vaccine every day, you don’t need to replant.

6pt;font-family:"Times New Roman";font-size:16pt;'> (2) Strengthen immunity.

(2) Strengthen immunity.

6pt;font-family:"Times New Roman";font-size:16pt;'> Boost immunization is not recommended at this stage.

Boost immunization is not recommended at this stage.

6pt;font-family:"Times New Roman";font-size:16pt;'> (3) Simultaneous vaccination with other vaccines.

(3) Simultaneous vaccination with other vaccines.

6pt;font-family:"Times New Roman";font-size:16pt;'> It is not recommended to vaccinate with other vaccines at the same time.
The interval between other vaccines and the new coronavirus vaccine should be greater than 14 days.
When rabies vaccine, tetanus vaccine, and immunoglobulin are needed due to animal injuries, trauma, etc.
, the interval between vaccination with the new coronavirus vaccine may not be considered.

It is not recommended to vaccinate with other vaccines at the same time.
The interval between other vaccines and the new coronavirus vaccine should be greater than 14 days.
When rabies vaccine, tetanus vaccine, and immunoglobulin are needed due to animal injuries, trauma, etc.
, the interval between vaccination with the new coronavirus vaccine may not be considered.
It is not recommended to vaccinate with other vaccines at the same time.
The interval between other vaccines and the new coronavirus vaccine should be greater than 14 days.
When rabies vaccine, tetanus vaccine, and immunoglobulin are needed due to animal injuries, trauma, etc.
, the interval between vaccination with the new coronavirus vaccine may not be considered.

6pt;font-family:"Times New Roman";font-size:16pt;'> (4) Replacement of different vaccine products.

(4) Replacement of different vaccine products.

6pt;font-family:"Times New Roman";font-size:16pt;'> At this stage, it is recommended to use the same vaccine product to complete the vaccination.
In special circumstances such as the inability to continue the supply of vaccines and the recipients are vaccinated in different places, and the same vaccine product cannot be used to complete the vaccination, the same type of vaccine products from other manufacturers can be used to complete the vaccination.

At this stage, it is recommended to use the same vaccine product to complete the vaccination.
In special circumstances such as the inability to continue the supply of vaccines and the recipients are vaccinated in different places, and the same vaccine product cannot be used to complete the vaccination, the same type of vaccine products from other manufacturers can be used to complete the vaccination.

6pt;font-family:"Times New Roman";font-size:16pt;'> (5) New coronavirus infection and antibody screening.

(5) New coronavirus infection and antibody screening.

6pt;font-family:"Times New Roman";font-size:16pt;'> There is no need to carry out new coronavirus nucleic acid and antibody testing before vaccination; routine antibody testing is not recommended as a basis for immunization success after vaccination.

There is no need to carry out new coronavirus nucleic acid and antibody testing before vaccination; routine antibody testing is not recommended as a basis for immunization success after vaccination.

6pt;font-family:"Times New Roman";font-size:16pt;'> (6) Contraindications for vaccination.

(6) Contraindications for vaccination.

6pt;font-family:"Times New Roman";font-size:16pt;'> The usual contraindications for vaccination include: ( 1) Those who are allergic to the active ingredients of the vaccine, any inactive ingredients, the substances used in the production process, or those who have had allergies during the previous vaccination of the same type of vaccine; ( 2) Have experienced serious vaccines in the past Allergic reactions (such as acute allergic reactions, angioedema, dyspnea, etc.
); (3) People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelination) Sheath diseases, etc.
); (4) Patients with fever, or suffering from acute diseases, or acute attacks of chronic diseases, or patients with uncontrolled severe chronic diseases; ( 5 ) Pregnant women.

The usual contraindications for vaccination include: ( 1) Those who are allergic to the active ingredient of the vaccine, any inactive ingredient, the substances used in the production process, or those who have had allergies during the previous vaccination of similar vaccines; ( 2) The vaccine has been severe in the past.
Allergic reactions (such as acute allergic reactions, angioedema, dyspnea, etc.
); (3) those with uncontrolled epilepsy and other severe neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelination) Sheath diseases, etc.
); (4) People who are feverish, or suffering from acute diseases, or acute attacks of chronic diseases, or patients with uncontrolled severe chronic diseases; ( Usually contraindications for vaccination include: ( 1) Active ingredients, Anyone who is allergic to any kind of inactive ingredients, substances used in the production process, or has allergies during previous vaccination of similar vaccines; ( 2) People who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, dyspnea Etc.
); (3) People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.
); (4) People who are feverish or suffering from acute diseases , Or acute attack of chronic disease, or uncontrolled severe chronic disease; ( 5 ) pregnant women.

6pt;font-family:"Times New Roman";font-size:16pt;'> This guide will refer to the following vaccination recommendations for specific populations for some people who are contraindicated or used with caution in the instructions.

This guide will refer to the following vaccination recommendations for specific populations for some people who are contraindicated or used with caution in the instructions.

6pt;font-family:"Times New Roman";font-size:16pt;'> 4.
Vaccination recommendations for specific populations

4.
Vaccination recommendations for specific populations

6pt;font-family:"Times New Roman";font-size:16pt;'> (1) People aged 60 and above.

(1) People aged 60 and above.
(1) People aged 60 and above.

6pt;font-family:"Times New Roman";font-size:16pt;'> People aged 60 and above are those at high risk of severe illness and death after being infected with the new coronavirus.
At present, the number of phase III clinical trials of the 4 new coronavirus vaccines with conditional approval for marketing has been included in this population in a limited number, and there is no data on the protective efficacy of the vaccine in this population.
However, data from phase I/II clinical studies show that this population is safe for vaccination.
Compared with the population of 18-59 years old, the neutralizing antibody titer after vaccination is slightly lower, but the positive conversion rate of neutralizing antibody is similar, suggesting that the vaccine is 60% People over the age of age will also have a certain protective effect, and vaccination is recommended.

People aged 60 and above are those at high risk of severe illness and death after being infected with the new coronavirus.
At present, the number of phase III clinical trials of the 4 new coronavirus vaccines with conditional approval for marketing has been included in this population in a limited number, and there is no data on the protective efficacy of the vaccine in this population.
However, data from phase I/II clinical studies show that this population is safe for vaccination.
Compared with the population of 18-59 years old, the neutralizing antibody titer after vaccination is slightly lower, but the positive conversion rate of neutralizing antibody is similar, suggesting that the vaccine is 60% People over the age of age will also have a certain protective effect, and vaccination is recommended.

6pt;font-family:"Times New Roman";font-size:16pt;'> (2) People under 18 years old.

(2) People under 18 years old.
(2) People under 18 years old.

6pt;font-family:"Times New Roman";font-size:16pt;'> At present, the existing vaccines have not yet obtained clinical trial data for this population, and it is not recommended for people under 18 years of age to be vaccinated.

At present, the existing vaccines have not yet obtained clinical trial data for this population, and it is not recommended for people under 18 years of age to be vaccinated.
At present, the existing vaccines have not yet obtained clinical trial data for this population, and it is not recommended for people under 18 years of age to be vaccinated.

6pt;font-family:"Times New Roman";font-size:16pt;'> (3) People with chronic diseases.

(3) People with chronic diseases.

6pt;font-family:"Times New Roman";font-size:16pt;'> People with chronic diseases are those who are severely ill and at high risk of death after being infected with the new coronavirus.
People with stable health conditions and well-controlled chronic diseases are not considered contraindications for new coronavirus vaccination and are recommended to be vaccinated.

People with chronic diseases are those who are severely ill and at high risk of death after being infected with the new coronavirus.
People with stable health conditions and well-controlled chronic diseases are not considered contraindications for new coronavirus vaccination and are recommended to be vaccinated.

6pt;font-family:"Times New Roman";font-size:16pt;'> (4) Women of childbearing age and breastfeeding period.

(4) Women of childbearing age and breastfeeding period.

6pt;font-family:"Times New Roman";font-size:16pt;'> If you get pregnant after vaccination or get the vaccine without knowing your 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 the new coronavirus vaccine.
It is recommended to do a pregnancy check and Follow up.
For women who have a pregnancy plan, there is no need to delay the pregnancy plan just because of the new coronavirus vaccine.

If you get pregnant after vaccination or get the vaccine without knowing your 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 the new coronavirus vaccine.
It is recommended to do a pregnancy check and Follow up.
For women who have a pregnancy plan, there is no need to delay the pregnancy plan just because of the new coronavirus vaccine.

6pt;font-family:"Times New Roman";font-size:16pt;'> Although there is currently no clinical research data on the impact of new coronavirus vaccines in breastfeeding women on breastfeeding infants, based on the understanding of the safety of the vaccine, it is recommended to vaccinate breastfeeding women (such as medical staff) who are at high risk of new coronavirus infections.
.
Considering the importance of breastfeeding to the nutrition and health of infants and young children, referring to internationally accepted practices, breastfeeding women are recommended to continue breastfeeding after being vaccinated against the new coronavirus.

Although there is currently no clinical research data on the impact of new coronavirus vaccines in breastfeeding women on breastfeeding infants, based on the understanding of the safety of the vaccine, it is recommended to vaccinate breastfeeding women (such as medical staff) who are at high risk of new coronavirus infections.
.
Considering the importance of breastfeeding to the nutrition and health of infants and young children, referring to internationally accepted practices, breastfeeding women are recommended to continue breastfeeding after being vaccinated against the new coronavirus.

6pt;font-family:"Times New Roman";font-size:16pt;'> (5) People with impaired immune function.

(5) People with impaired immune function.

6pt;font-family:"Times New Roman";font-size:16pt;'> People with impaired immune function are those at high risk of severe illness and death after being infected with the new coronavirus.
There is currently no data on the safety and effectiveness of the new coronavirus vaccine for the population (such as patients with malignant tumors, nephrotic syndrome, and AIDS) and people infected with human immunodeficiency virus ( HIV).
The immune response and protective effect of this group of people after vaccination may be reduced.
For inactivated vaccines and recombinant subunit vaccines, based on the safety characteristics of previous vaccines of the same type, vaccination is recommended; for adenovirus vector vaccines, although the vector virus used is replication defective, there is no safety data for the use of the same type of vaccine in the past.
It is recommended that after being fully informed, the individual weighs the benefits outweigh the risks and vaccinates.

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