2022-06-02-世界卫生组织-Sinopharm_Vero_Cell_-_Inactivated,_COVID-19_vaccine_7页_209kb

报告摘要

Summary of the SARS-CoV-2 Vaccine (Vero Cell), Inactivated (Sinopharm)

Core Content

The SARS-CoV-2 Vaccine (Vero Cell), Inactivated (Sinopharm) is developed by Beijing Institute of Biological Products Co., Ltd. It is an inactivated vaccine that stimulates the immune system without causing disease. The vaccine is adjuvanted with aluminum hydroxide to enhance immune response and is preservative-free. It is available in single-dose vials, 2-dose vials, and 5-dose vials, as well as in non-AD prefilled syringes. The vaccine is administered intramuscularly into the deltoid muscle.

Efficacy and Safety

A multi-country phase 3 trial demonstrated 79% efficacy against symptomatic SARS-CoV-2 infection and 79% efficacy against hospitalization, 14 days or more after the second dose.
The median follow-up duration was 112 days.
No specific data on vaccine effectiveness against variants have been published.
Safety profile is generally mild to moderate, with common local events including pain at the injection site, and systemic events such as headache, fever, fatigue, and muscle pain.
Anaphylaxis is not known to be associated with this vaccine.
The vaccine is not live, so it is unlikely to pose a risk to breastfeeding children, and breastfeeding should not be discontinued after vaccination.

Vaccination Schedule and Administration

Recommended age: 18 years and older.
Primary series: 2 doses of 0.5 mL, 3 to 4 weeks apart.
- If the second dose is given earlier than 3 weeks, it does not need to be repeated.
- If delayed beyond 4 weeks, it should be given as soon as possible.
Extended primary series (for ≥60 years and immunocompromised persons):
- 3 doses (0.5 mL each), with the third dose given 3 to 6 months after the second for older adults, and 1 to 3 months for immunocompromised persons.
Booster dose:
- Recommended for high-priority groups (e.g., older adults, health workers, persons with comorbidities).
- Should be given 4 to 6 months after the primary or extended primary series.
- Heterologous boosters (e.g., mRNA or viral vector vaccines) are preferred over homologous boosters (inactivated vaccines).

Special Populations

Pregnant women: Vaccination is recommended if the benefits outweigh potential risks. No need for pregnancy testing before vaccination. Delaying or terminating pregnancy due to vaccination is not recommended.
Persons living with HIV (PLWH): Vaccination is possible for those with CD4 count >200 cells/μL and viral suppression. No pre-vaccination HIV testing is required.
Immunocompromised persons (ICP): Third dose is recommended as part of the extended primary series. A booster dose may be considered 3 to 6 months after the third dose, and should be heterologous.
Persons in special settings (e.g., refugee camps, prisons, slums): Should be prioritized for vaccination based on national epidemiological data and vaccine supply.

VVM and Packaging Information

VVM Type: Type 7.
Vial and syringe presentation:
- Single-dose vials and non-AD prefilled syringes contain 0.5 mL per dose.
- 2-dose vials contain 1 mL (0.5 mL per dose).
- 5-dose vials contain 2.5 mL (0.5 mL per dose).
Packaging dimensions:
- Monodose pre-filled syringes: Carton sizes vary from 10.4 × 4.5 × 2.1 cm to 43.0 × 33.0 × 24.5 cm.
- Single-dose vials: Carton sizes vary from 7.2 × 3.9 × 2.2 cm to 42.5 × 27.5 × 24.0 cm.
- Two- and five-dose vials: Carton sizes vary from 7.2 × 3.9 × 2.2 cm to 43.5 × 28.0 × 28.0 cm.
Storage: Must be kept in a refrigerator at +2 to +8 °C, not frozen or exposed to direct sunlight and ultraviolet light.
Shelf life: 24 months when unopened and stored at +2 to +8 °C.

Co-administration and Other Considerations

Co-administration with inactivated influenza vaccine is possible.
Minimum interval of 14 days is required between this vaccine and any other vaccine until more data are available.
Vaccination should not be delayed due to minor infections (e.g., cold, low-grade fever).
Persons with acute SARS-CoV-2 infection should wait until recovered and isolation criteria are met before vaccination.
Vaccine recipients should be informed about post-vaccination symptoms and observed for 15 minutes after vaccination.
Antipyretics or analgesics may be used to alleviate symptoms, but routine prophylaxis is not advised.

Important Reminders

Vaccination should continue regardless of prior symptomatic or asymptomatic infection.
Viral or serological testing is not recommended for vaccine decision-making.
Hybrid immunity (from both vaccination and natural infection) is superior to immunity from either alone.
Occupational groups (e.g., health workers) may require time off work due to reactogenicity effects observed in trials.