Updated on 5 January 2022, pursuant to updated interim recommendations on heterologous use of vaccines.
On 3 November 2021, the Technical Advisory Group for Emergency Use Listing listed the Bharat Biotech BBV152 COVAXIN vaccine against COVID-19 for emergency use. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim policy recommendations for the use of the Bharat Biotech BBV152 COVAXIN vaccine. This article provides a summary of those interim recommendations.
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The background document is also available here.
Who should be vaccinated first?
Where COVID-19 vaccine supplies are limited, priority should go to health workers at high risk of exposure and older people.
Countries can refer to the WHO Prioritization Roadmap and the WHO Values Framework for guidance.
The vaccine is not recommended for people younger than 18 years of age. Safety and immunogenicity data for under-18s are currently being generated but until such data are available, vaccination of individuals in this age group is not recommended.
Who else can take the vaccine?
Vaccination is recommended for people living with conditions that have been identified as increasing the risk of severe COVID-19, including cardiovascular disease, respiratory disease, diabetes, liver disease and obesity.
The vaccine can be offered to people who have had COVID-19 in the past. Available data shows that symptomatic reinfection is unlikely for up to 6 months after infection. Those with documented infection may therefore choose to delay vaccination to nearer the end of this period, especially when vaccine supply is limited, to allow others priority for vaccination.
WHO recommends the same use of BBV152 vaccine in breastfeeding and non-breastfeeding women. Data are not available on the potential benefits or possible risks of the BBV152 vaccine to breastfed children. However, as BBV152 vaccine is not a live virus vaccine, it is biologically and clinically unlikely to pose a risk to the breastfeeding child. WHO does not recommend discontinuing breastfeeding because of vaccination.
Persons living with human immunodeficiency virus (HIV) or who are immunocompromised are at higher risk of severe COVID-19 disease. There are not enough data at present to allow assessment of the efficacy or safety of this vaccine for people living with HIV. It is possible that the immune response to the vaccine may be reduced, which could lower its clinical effectiveness. In the interim, however, given that the vaccine is nonreplicating, people living with HIV that is stable may be vaccinated with the standard primary series of 2 doses.
Should pregnant women be vaccinated?
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There are not currently sufficient data on the BBV152 vaccine in pregnant women to assess vaccine safety in pregnancy, although studies in pregnant women are planned. Post marketing safety data from India, where over 120 000 pregnant women have received this vaccine, found only minor adverse events related to the vaccine, but data on neonatal outcomes have not yet been collected. On the basis of previous experience with use of other inactivated vaccines used during pregnancy, the effectiveness of BBV152 vaccine in pregnant women is expected to be comparable to that observed in non-pregnant women of similar age. WHO recommends the use of BBV152 vaccine in pregnant women if 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 the safety data in pregnant women.
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 BBV152 vaccine as 2 doses (0.5 ml) given intramuscularly. The vaccine can be administered with an interval of 4 weeks. It is recommended that all vaccinated individuals receive two doses.
If the second dose is inadvertently administered less than 4 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.
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.
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 Bharat COVID-19 vaccine dependant on product availability.
How does this vaccine compare to other COVID-19 vaccines already in use?
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It is impossible to 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 safety and efficacy of the vaccine and has recommended its use for people aged 18 and above. The WHO EUL process also evaluates the quality of manufacturing along with safety and efficacy.
Safety data is currently limited for persons above 60 years of age (due to the small number of participants of this age group in clinical trials). However, the trial data indicate that the vaccine has an acceptable safety profile for this age group and WHO recommends the vaccine for use in persons aged 60 years and over.
BBV152 has been licensed for use in 23 countries globally; however roll-out has been limited mostly to India where over 77 million doses have been distributed and used. Vaccine effectiveness studies are being conducted in India, and results will be available in the coming months.
How efficacious is the vaccine?
Vaccine efficacy against COVID-19 of any severity, 14 or more days post dose 2, was 78%. Vaccine efficacy against severe disease is 93%. In adults aged less than 60 years, efficacy was 79%; and in those aged 60 years and over it was 68%.
Does it work against new variants of SARS-CoV-2 virus?
Vaccine efficacy against all variant-related COVID-19 disease was 71% with an efficacy of 90% against Kappa, and 65% against Delta. In view of these findings, WHO recommends the use of BBV152 vaccine according to the WHO Prioritization Roadmap, even if currently recognized Variants of Concern (VOC) are present in the country. If new VOCs emerge for which vaccine performance is compromised, these recommendations will be updated accordingly. There are no data yet for Omicron.
Does it prevent infection and transmission?
Vaccine efficacy against asymptomatic SARS-CoV-2 infection was 64%.
As there is not currently sufficient evidence to date to evaluate the impact of the vaccine on transmission, public health and social measures must continue, including use of face masks, physical distancing, handwashing, appropriate ventilation, and other measures as appropriate in particular settings, depending on the COVID-19 epidemiology and potential risks of emerging variants. Government advice on public health and social measures should continue to be followed by both vaccinated and unvaccinated individuals. SAGE will update this advice as information on the impact of vaccination on virus transmission and indirect protection is assessed.
This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting.
