China News Service, March 29. The National Health Commission released the "New Coronavirus Vaccination Technical Guidelines (First Edition)" (hereinafter referred to as the "Guide") on its official website on the 29th.
In terms of vaccination recommendations for specific populations, the guidelines are clear. Existing research data shows that re-infection is rare within 6 months after the new coronavirus infection.
People who have been infected with the new coronary pneumonia virus (patients or asymptomatic infections) can receive one dose after 6 months on the basis of full notification.
Data map: Citizens are vaccinated against the new coronavirus.
Photo by Yu Jing
According to the guidelines, at present, my country has 5 manufacturers of new coronavirus vaccines approved for conditional marketing or emergency use.
The results of the interim analysis of the phase III clinical trials of the three inactivated vaccines and adenovirus vector vaccines that were conditionally approved for marketing showed that the protective efficacy of the vaccines all reached the National Medical Products Administration "Guidelines for Clinical Evaluation of New Coronavirus Preventive Vaccines (Trial)" The requirements also meet the index requirements recommended by the World Health Organization’s "New Coronavirus Vaccine Target Product Characteristics".
Surveillance data of suspected abnormal response to vaccination after large-scale vaccination in key populations during clinical trials and emergency use stage and early stage showed that the new coronavirus vaccine is safe.
The results of the Phase II clinical trial of the recombinant new coronavirus vaccine (CHO cell) approved for emergency use showed good immunogenicity and safety.
The guidelines clarify the recommended immunization procedures, applicable to people 18 years of age and above.
In terms of the number and interval of inoculation doses, the guidelines propose: 1. The new coronavirus inactivated vaccine (Vero cells), inoculate 2 doses; the interval between the 2 doses is recommended to be ≥3 weeks, and the second dose should be completed as soon as possible within 8 weeks.
2. Recombinant new coronavirus vaccine (type 5 adenovirus vector), inoculate 1 dose.
3. Recombinant new coronavirus vaccine (CHO cells), 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.
Among them, intramuscular injection into the deltoid muscle of the upper arm is recommended for the route and site of inoculation.
For late replanting, the guidelines are clear. For those who have not completed the vaccination program for the 2 or 3-dose 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 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.
For those who have completed 2 doses of inactivated new coronavirus vaccination within 14-21 days, there is no need to replant.
At the same time, booster immunization is not recommended for the time being during the emergence of the guidelines.
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.
In addition, it is recommended to complete vaccination with the same vaccine product at this stage.
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 the same time, the guidelines clarify that 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.
Regarding vaccination contraindications, common vaccination contraindications 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 previous vaccination of similar vaccines; (2) Those who have had severe allergic reactions to the vaccine in the past (such as acute allergies) Reaction, angioedema, dyspnea, etc.); (3) people with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating 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.
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.
Vaccination recommendations for specific populations
——People aged 60 and above
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, the data of phase I/II clinical studies show that this population has good vaccination safety. 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 under 18
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.
——People with chronic diseases
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.
——Women of childbearing age and breastfeeding period
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.
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 vaccine safety, 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.
-People with impaired immune function
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 malignant tumors, nephrotic syndrome, AIDS patients) and human immunodeficiency virus (HIV) infections.
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, individuals weigh the benefits outweigh the risks and vaccinate.
——Past patients or infected persons
Existing research data shows that there are rare cases of re-infection within 6 months after the new coronavirus infection.
People who have been infected with the new coronary pneumonia virus (patients or asymptomatic infections) can receive one dose after 6 months on the basis of full notification.
The "Guide" stated that as more new coronavirus vaccines are approved for use, vaccine clinical research data continues to improve, and vaccine monitoring and evaluation data increase after the market is launched, this guide will be updated in due course according to the needs of the epidemic prevention and control situation.