The WHO Strategic Advisory Group of Experts (SAGE) on Immunization 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 recommendations and the background document are also available online.
Who should be vaccinated first?
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 the WHO Prioritization Roadmap and the WHO Values Framework as guidance for their prioritization of target groups.
Should pregnant women be vaccinated?
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.
Who else should be vaccinated?
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 6 months may therefore choose to delay vaccination until near the end of this period. In settings where variants of concerns with evidence of immune escape are 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.
Who is the vaccine not recommended for?
Individuals with a history of anaphylaxis to any component of the vaccine should not take it.
Anyone with a body temperature over 38.5ºC should postpone vaccination until they no longer have a fever.
What’s the recommended dosage for Sinopharm?
SAGE recommends the use of BIBP vaccine as 2 doses (0.5 ml) given intramuscularly. WHO recommends an interval of 3–4 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.
How does this vaccine compare to other vaccines already in use?
We cannot compare the vaccines head-to-head due to the different approaches taken in designing the respective studies, but overall, all the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease and hospitalization due to COVID-19.
Is Sinopharm vaccine safe?
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.
How effective is the vaccine?
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.