Technical guideline for the inoculation of COVID-19 vaccines

So far, China has approved four COVID-19 vaccines for conditional marketing and one for emergency use. Phase III clinical trials of three inactivated vaccines and one adenovirus vaccine approved for conditional marketing show their efficacy rates meet the requirements of the National Medical Products Administration and the World Health Organization. Phase II trials of the recombinant protein subunit vaccine (CHO cell) approved for emergency use show the vaccine is safe and can induce a strong immune response.

The National Health Commission has published a guideline on the use of COVID-19 vaccines. Here is some key information from the guideline.

1. Types of vaccines:

(1) Inactivated vaccine

The three inactivated vaccines are respectively made by Beijing Biological Products Institute Co Ltd and Wuhan Institute of Biological Products Co Ltd, two affiliates of China National Pharmaceutical Group Co Ltd (SinoPharm), and Sinovac Biotech Ltd.

(2) Adenovirus vector vaccine

The adenovirus vector vaccine is made by CanSino Biologics Inc.

(3) Recombinant protein subunit vaccine

This vaccine is produced by the Anhui Zhifei Longcom Biopharmaceutical Co Ltd.

2. Recommended vaccination procedure

(1) People suitable for vaccination

Those aged 18 or above.

(2) Doses and vaccination intervals

a. Inactivated vaccines (Vero cell)

Two doses; interval: 3-8 weeks.

b. Recombinant protein subunit vaccine

One dose.

c. Recombinant protein subunit vaccine (CHO cell)

Three doses; interval: no less than four weeks between two shots, second dose administered within eight weeks after the first shot, third dose within six months after the first.

(3) How and where to inoculate

Intramuscular injections in deltoid in upper arm.

3 Other matters of concern

(1) Late vaccination or follow-up vaccination

For the two-dose or three-dose vaccination, if you have not completed the vaccination within the schedule, it is recommended to continue the vaccination as soon as possible. You do not need to start over again.

For those who have received two doses of inactivated vaccines within 14 days, one dose of follow-up inactivated vaccine should be given within three weeks of the second dose. For those who have received two doses of inactivated vaccines within 14-21 days, there is no need for more doses.

(2) Booster shot

Booster shots are not recommended for the time being.

(3) Simultaneous inoculation with other vaccines

It is not recommended to take the COVID-19 vaccine with other vaccines at the same time. The interval between the inoculation of COVID-19 vaccine and other vaccines should be longer than 14 days. Such an interval is not required when being inoculated with the rabies vaccine, tetanus vaccine, or immune globulin due to injuries.

(4) Replacement

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

(5) Infection testing and antibody screening

There is no need to carry out nucleic acid and antibody testing before vaccination; and it is not recommended to have routine antibody testing after vaccination to evaluate whether an immune response has been elicited.

(6) Groups not suitable for vaccination

a. Those who are allergic to the ingredients of the vaccine or who have history of allergy to the same type of vaccine;

b. History of serious allergy to vaccines (such as acute allergic reactions, angioedema, breathing difficulty);

c. People with uncontrolled epilepsy and other serious neurological diseases;

d. Patients with fever, or acute diseases, or during acute attacks of chronic diseases, or patients with uncontrolled severe chronic diseases;

e. Women during pregnancy.

4. Vaccination recommendations for specific groups

(1) People aged 60 or above

People aged 60 or above are at higher risk of developing severe symptoms or dying after being infected with the novel coronavirus. At present, there are limited phase III clinical trials of the four vaccines with conditional approval for market use on this group of people and there is no data on the protection efficacy of the vaccines for this group.

However, the data of phase I and II clinical trials has shown that the vaccines are safe. The concentration of vaccine-induced neutralizing antibody is slightly lower than observed in people aged between 18 and 59, but the positive conversion rate of the neutralizing antibody is similar, suggesting that the vaccines provide a certain degree of protection for people aged 60 or above.

Thus, vaccination is recommended for this age group.

(2) People under 18

No clinical trial data has been obtained for people in this age group, so it is not recommended that people under 18 be vaccinated.

(3) People with chronic diseases

People with chronic diseases are at higher risk of developing severe symptoms or dying after being infected with the novel coronavirus. Patients in stable condition and whose chronic diseases are well-controlled are recommended for vaccination.

(4) Women of childbearing age or breastfeeding women

If you get pregnant after vaccination or get the vaccine without knowing you are pregnant, it is not recommended to take special medical measures (such as termination of pregnancy) because of the vaccination. It is recommended to do a pregnancy check and follow-up checks. For women who plan to have child, there is no need to delay pregnancy just because of the vaccination.

Although there is currently no clinical research data on the impact of COVID-19 vaccines on breastfeeding women and infants, it is recommended that breastfeeding women who are at higher risk of infections (such as medical staff) be vaccinated.

Considering the importance of breastfeeding to the health of infants and young children and according to internationally accepted practices, breastfeeding women are recommended to continue breastfeeding after being vaccinated.

(5) People with impaired immunity

People with impaired immunity are at higher risk of developing severe symptoms or dying after being infected with the novel coronavirus. There is currently no data on the safety and effectiveness of COVID-19 vaccines for this group of people (such as people with malignant tumors, nephrotic syndrome and AIDS) and people infected with HIV.

The immune response and protection effect of this group of people after vaccination may be reduced. Inactivated vaccines and the recombinant subunit vaccine are recommended; for the adenovirus vector vaccine, it is recommended that individuals are fully informed and fully consider the benefits and the risks before vaccination.

(6) People who have been infected with the novel coronavirus

Existing research data shows that there are rare cases of re-infection within six months after being infected with the novel coronavirus. People who have been infected (confirmed patients or asymptomatic cases) can receive one dose of vaccine after six months on the basis of full notification.