Updated on 10 June 2022, pursuant to revised interim recommendations.
The WHO Strategic Advisory Group of Experts (SAGE) has issued interim recommendations for the use of the Sinopharm vaccine against COVID-19. This article provides a summary of those interim recommendations; you may access the full guidance document here.
Here is what you need to know.
Who can be vaccinated?
The vaccine is safe and effective for all individuals aged 18 and above. In line with the WHO Prioritization Roadmap and the WHO Values Framework, older adults, health workers and immunocompromised persons should be prioritised.
The Sinopharm vaccine can be offered to people who have had COVID-19 in the past. But individuals may choose to delay vaccination for 3 months following the infection.
Should pregnant and breastfeeding women be vaccinated?
The available data on the COVID-19 vaccine Sinopharm 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 Sinopharm 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 Sinopharm 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.
Vaccine effectiveness is expected to be similar in breastfeeding women as in other adults. WHO recommends the use of the COVID-19 vaccine Sinopharm in breastfeeding women as in other adults. WHO does not recommend discontinuing breastfeeding after vaccination.
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.
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.
What’s the recommended dosage?
SAGE recommends the use of Sinopharm vaccine as 2 doses (0.5 ml) given intramuscularly.
SAGE recommends that a third, additional dose of the Sinopharm vaccine be offered to persons aged 60 and above as part of an extension of the primary series. Current data does not indicate the need for an additional dose in persons under 60 years of age.
SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary vaccination series and are at higher risk of severe COVID-19 disease.
WHO recommends an interval of 3–4 weeks between the first and second dose of primary series. 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. When administering an additional dose to over 60s, SAGE recommends countries should initially aim at maximizing 2-dose coverage in that population, and thereafter administer the third dose, starting with the oldest age groups.
Is a booster dose recommended for this vaccine?
A booster dose may be considered 4 – 6 months after completion of the primary vaccination series, starting with the higher priority-use groups, in accordance with the WHO Prioritization Roadmap.
The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time.
Either homologous (a different vaccine product to Sinopharm) or heterologous (a booster dose of Sinopharm) doses can be used. A study in Bahrain found that heterologous boosting resulted in a superior immune response compared to homologous boosting.
Can this vaccine be ‘mixed and matched’ with other vaccines?
SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series.
To ensure equivalent or favourable immunogenicity or vaccine effectiveness either of the WHO EUL COVID-19 mRNA vaccines (Pfizer or Moderna) or the WHO EUL COVID-19 vectored vaccines (AstraZeneca Vaxzevria/COVISHIELD or Janssen) can be used as a second dose following a first dose with the Sinopharm vaccine dependent on product availability.
Does it prevent infection and transmission?
There is currently no substantive data available related to the impact of Sinopharm 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.
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.
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.
Post time: Jun-15-2022