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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, Sinovac-CoronaVac, developed by Sinovac/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 prioritised for vaccination.
Countries can refer to the WHO Prioritization Roadmap and the WHO Values Framework as guidance for their prioritisation of target groups.
The vaccine is not recommended for persons younger than 18 years of age, pending the results of further studied in that age group.
Should pregnant women be vaccinated?
The available data on the Sinovac-CoronaVac (COVID-19) vaccine in pregnant women are insufficient to assess either vaccine efficacy or possible vaccine-associated risks in pregnancy. However, this vaccine is an inactivated vaccine with an adjuvant that is commonly used in many other vaccines with a well-documented safety profile, such as Hepatitis B and Tetanus vaccines, including in pregnant women. The effectiveness of the Sinovac-CoronaVac (COVID-19) vaccine in pregnant women is therefore expected to be comparable to that observed in non-pregnant women of similar age. Further studies are expected to evaluate safety and immunogenicity in pregnant women.
In the interim, WHO recommends the use of the Sinovac-CoronaVac (COVID-19) vaccine 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?
Vaccination is recommended for persons with comorbidities that have been identified as increasing the risk of severe COVID-19, including obesity, cardiovascular disease and respiratory disease.
The vaccine can be offered to people who have had COVID-19 in the past. Available data shows that symptomatic reinfection is unlikely in these persons for up to 6 months after natural infection. Consequently, they may choose to delay vaccination to nearer the end of this period, especially when vaccine supply is limited. 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 Sinovac-CoronaVac in lactating women as in other adults. WHO does not recommend discontinuing breastfeeding after vaccination.
Persons living with human immunodeficiency virus (HIV) or who are immunocompromised are at higher risk of severe COVID-19 disease. Such persons were not included in the clinical trials informing SAGE’s review, but given this is a non-replicating vaccine, persons living with HIV or who are immunocompromised and 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.
Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for ending isolation have been met.
Anyone with a body temperature over 38.5°C should postpone vaccination until they no longer have a fever.
What is the recommended dosage?
SAGE recommends the use of Sinovac-CoronaVac vaccine as 2 doses (0.5 ml) given intramuscularly. WHO recommends an interval of 2–4 weeks between the first and second dose. It is recommended that all vaccinated individuals receive two doses.
If the second dose is administered less than 2 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.
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 is currently 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.
As part of the EUL process, Sinovac has committed to continuing submit data on safety, efficacy and quality in ongoing vaccine trials and rollout in populations, including in older adults.
How efficacious is the vaccine?
A large phase 3 trial in Brazil showed that two doses, administered at an interval of 14 days, had an efficacy of 51% against symptomatic SARS-CoV-2 infection, 100% against severe COVID-19, and 100% against hospitalization starting 14 days after receiving the second dose.
Does it work against new variants of SARS-CoV-2 virus?
In an observational study, the estimated effectiveness of Sinovac-CoronaVac in health workers in Manaus, Brazil, where P.1 accounted for 75% of SARS-CoV-2 samples was 49.6% against symptomatic infection (4). Effectiveness has also been shown in an observational study in Sao Paulo in the presence of P1 circulation (83% of samples).
Assessments in settings where the P.2 Variant of Concern was widely circulating – also in Brazil – estimated vaccine effectiveness of 49.6% following at least one dose and demonstrated 50.7% two weeks after the second dose. As new data becomes available, WHO will update recommendations accordingly.
SAGE currently recommends using this vaccine, according to the WHO Prioritization Roadmap.
Does it prevent infection and transmission?
There is currently no substantive data available related to the impact of COVID-19 vaccine Sinovac-CoronaVac on transmission of SARS-CoV-2, the virus that causes COVID-19 disease.
In the meantime, WHO reminds of the need to stay the course and continue practising public health and social measures that should be used as a comprehensive approach to prevent infection and transmission. These measures include wearing a mask, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds and ensuring adequate ventilation according to local national advice.
