The Sinopharm COVID-19 vaccine: What you need to know – World Health Organization

The WHO Strategic Advisory Group of Experts (SAGE) on Immunization has issued Interim recommendations for the use of the inactivated COVID-19 vaccine BIBP developed by Sinopharm/China National Pharmaceutical Group.

Here is what you need to know.

This article provides a summary of the interim recommendations; the interim recommendationsand thebackground document are also available online.

While COVID-19 vaccine supplies are limited, health workers at high risk of exposure and older people should be prioritized for vaccination.

The vaccine is not recommended for persons younger than 18 years of age, pending the results of further studies in that age group.

Countries can refer to theWHO Prioritization Roadmapand theWHO Values Frameworkas guidance for their prioritization of target groups.

The available data on the COVID-19 vaccine BIBP in pregnant women are insufficient to assess either vaccine efficacy or vaccine-associated risks in pregnancy. However, this vaccine is an inactivated vaccine with an adjuvant that is routinely used in many other vaccines with a documented good safety profile, including in pregnant women. The effectiveness of the COVID-19 vaccine BIBP in pregnant women is therefore expected to be comparable to that observed in non-pregnant women of similar age.

In the interim, WHO recommends the use of the COVID-19 vaccine BIBP in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks. To help pregnant women make this assessment, they should be provided with information about the risks of COVID-19 in pregnancy; the likely benefits of vaccination in the local epidemiological context; and the current limitations of safety data in pregnant women. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or considering terminating pregnancy because of vaccination.

The vaccine can be offered to people who have had COVID-19 in the past. Within 6 months after an initial natural infection, available data show that symptomatic reinfection is uncommon. Given limited vaccine supply, persons with PCR-confirmed SARS-CoV-2 infection in the preceding 6months may therefore choose to delay vaccination until near the end of this period. In settings where variants of concerns with evidence of immune escapeare circulating earlier immunization after infection may be advisable.

Vaccine effectiveness is expected to be similar in lactating women as in other adults. WHO recommends the use of the COVID-19 vaccine BIBP in lactating women as in other adults. WHO does not recommend discontinuing breastfeeding after vaccination.

Persons living with human immunodeficiency virus (HIV) are at higher risk of severe COVID-19 disease. Persons living with HIV were not included in the trial but given this is a non-replicating vaccine, persons living with HIV who are a part of the recommended group for vaccination may be vaccinated. Information and counselling, wherever possible, should be provided to inform individual benefit-risk assessment.

Individuals with a history of anaphylaxis to any component of the vaccine should not take it.

Anyone with a body temperature over 38.5C should postpone vaccination until they no longer have a fever.

SAGE recommends the use of BIBP vaccine as 2 doses (0.5 ml) given intramuscularly. WHO recommends an interval of 34 weeks between the first and second dose. If the second dose is administered less than 3 weeks after the first, the dose does not need to be repeated. If administration of the second dose is delayed beyond 4 weeks, it should be given at the earliest possible opportunity. It is recommended that all vaccinated individuals receive two doses.

We cannot compare the vaccines head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease and hospitalization due to COVID-19.

SAGE has thoroughly assessed the data on quality, safety and efficacy of the vaccine and has recommended its use for people aged 18 and above.

Safety data are limited for persons above 60 years of age (due to the small number of participants in clinical trials). While no differences in safety profile of the vaccine in older adults compared to younger age groups can be anticipated, countries considering using this vaccine in persons older than 60 years should maintain active safety monitoring.

A large multi-country Phase 3 trial has shown that 2 doses, administered at an interval of 21 days, have an efficacy of 79% against symptomatic SARS-CoV-2 infection 14 or more days after the second dose. Vaccine efficacy against hospitalization was 79%.

The trial was not designed and powered to demonstrate efficacy against severe disease in persons with comorbidities, in pregnancy, or in persons aged 60 years and above. Women were underrepresented in the trial. The median duration of follow-up available at the time of evidence review was 112 days.

Two other efficacy trials are under way but data are not yet available.

SAGE currently recommends using this vaccine, according to the WHO Prioritization Roadmap.

As new data becomes available, WHO will update recommendations accordingly. This vaccine has not yet been evaluated in the context of circulation of widespread variants of concern.

There is currently no substantive data available related to the impact of COVID-19 vaccine BIBP on transmission of SARS-CoV-2, the virus that causes COVID-19 disease.

In the meantime, WHO reminds of the need to maintain and strengthen public health measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds and ensuring adequate ventilation.

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The Sinopharm COVID-19 vaccine: What you need to know - World Health Organization