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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 recommendations and the background document are also available online.
Who made it and is it approved?
The BBIBP in China has developed the Sinopharm COVID-19 vaccine BBIBP-CorV. Of the COVID-19 vaccines that Chinese companies have produced, BBIBP-CorV is the first one that the WHO has authorizedTrusted Source for use against the SARS-CoV-2 virus.
The WHO issued its emergency use listing for the Sinopharm vaccine on May 7, 2021, some 4 months after China’s National Medical Products Administration authorized it on December 31, 2020. A further 42 countries, including Hungary, Venezuela, and Sri Lanka, have approved the vaccine. However, the European Medicines Agency (EMA) has not yet reviewed it for use in the European Union.
How does it work?
Sinopharm and the BBIBP opted to use a well-established technology to develop their COVID-19 vaccine. The two-dose vaccine incorporates inactivated virus to stimulate an immune response.
The Sinopharm vaccine contains SARS-CoV-2 that has undergone treatment with a chemical called beta-propiolactone. This chemical binds to the virus’s genetic material and stops it from replicating and causing COVID-19. The vaccine also contains an adjuvant in the form of aluminum hydroxide. Adjuvants help strengthen the body’s immune response to vaccines.
When an individual receives the vaccine, their body’s immune system identifies the inactivated virus as foreign and makes antibodies against it. If the vaccinated person subsequently comes into contact with SARS-CoV-2, their immune system launches an immune response against it.
The WHO recommends the Sinopharm vaccine for people aged 18 years and older, with a gap of 3–4 weeks between the two doses. The global health agency estimates overall vaccine efficacy to be about 78%, although it notes that trial data are lacking for adults over the age of 60 years.
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.
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.
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.
Who else can take the vaccine?
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?
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 of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease and hospitalization due to COVID-19.
Is it 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 efficacious 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.
Two other efficacy trials are under way but data are not yet available.
Does it work against new variants of SARS-CoV-2 virus?
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.
Does it prevent infection and transmission?
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.
Where can I get vaccinated in Abu Dhabi
Abu Dhabi Health Services Company (SEHA) has announced starting to provide Sinopharm’s COVID-19 vaccine to children aged 3 to 17 in centres and facilities across its network, available for walk-ins. This announcement follows the Ministry of Health and Prevention’s (MoHAP) approval for emergency use based on the clinical trials and local evaluations.
The Pfizer vaccine will continue being administered to individuals aged 12 years old and over, as normal.
For Abu Dhabi residents and visitors, vaccinations for the 3-17 age group will be provided through the COVID-19 Vaccination Centre at Abu Dhabi National Exhibition Centre, Al Mushrif Children’s Specialty Centre, Majlis Al Mushrif, Majlis Al Manhal and Majlis Al Bateen.
Meanwhile, residents and visitors of Al Ain can vaccinate their children through the SEHA COVID-19 Vaccination Centre at Al Ain Convention Centre, Al Towayya Children’s Specialty Centre, or Majlis Falaj Hazaa, while those living in Al Dhafra can visit Majlis Dalma, Majlis Ghayathi, Majlis Al Marfaa, Majlis Liwa, Majlis Alsila’a, Al-Dhafra Family Medicine Centre, or the SEHA COVID-19 Vaccination Centre at Al-Dhafra Association Hall.
For more information, members of the community are encouraged to call 800 50 or visit