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The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for the use of the Janssen Ad26.COV2.S COVID-19 vaccine against COVID-19.
Here is the summary of the interim recommendations:
India
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New Delhi, June 09, 2022:
Who can take the vaccine?
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 Janssen vaccine can be offered to people who have had COVID-19 in the past. But individuals may wish to may choose to delay vaccination for 3 months following the infection.
Can immunocompromised persons take the vaccine?
Persons with immunocompromising conditions are at higher risk of severe COVID-19 and should be vaccinated. WHO recommends a second dose for all people with immunocompromising conditions aged 18 years and older. Available evidence suggests that this dose should be given 1–3 months after the first dose in order to increase protection as quickly as possible.
The most appropriate timing for a third dose may vary depending on the epidemiological setting and the extent and timing of immune suppressive therapy, and should be discussed with a Doctor. There are no data available to determine the need and timing of additional doses. As data become available, these recommendations will be updated.
Should pregnant women be vaccinated?
The Janssen vaccine is a nonreplicating vaccine. No safety issues have been identified following vaccination of more than 1,600 pregnant women using this vaccine platform for vaccines against other pathogens, such as the Ebola virus. Animal developmental and reproductive toxicity studies show no harm to the development of the foetus.
WHO has identified pregnant women as a priority-use group for COVID-19 vaccination, given their increased risk of severe outcomes. WHO recommends the use of the Janssen vaccine in pregnancy when the benefits of vaccination to the pregnant person outweigh the potential risks. This assessment should be made with the appropriate information on risks and benefits. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination.
Who is the vaccine not recommended for?
Individuals with a history of anaphylaxis to any component of the vaccine should not take it.
People who have had Thrombosis with thrombocytopenia (TTS) following the first dose of this vaccine should not receive a second dose of the same vaccine.
Anyone with a body temperature over 38.5ºC should postpone vaccination until they no longer have a fever.
This vaccine is not recommended for persons younger than 18 years of age pending the results of further studies in that age group.
What’s the recommended dosage?
A single dose regimen, in keeping with the EUL recommendations for this vaccine, remains an acceptable option for countries, especially when faced with supply constraints and difficulties to reach remote populations.
However, given the evidence demonstrating improved protection with a second dose, WHO recommends that all efforts should be taken to provide two doses, in particularly to the highest and high priority-use. The administration of the second dose will result in increased protection against symptomatic infection, and against severe disease.
What intervals should there be between doses?
WHO recommends that the second dose should be given 2-6 months after the first dose. Studies show there is improved immunogenicity with longer inter-dose interval and countries could therefore consider an inter-dose interval of up to 6 months.
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.
This vaccine has also undergone review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) and found to be safe for use. A rare serious adverse event is the “thrombosis with thrombocytopenia syndrome” and “Guillain-Barre Syndrome”.
How efficacious is the vaccine?
Studies show that a second dose 2 months after the initial dose substantially increases efficacy, especially against symptomatic infections, including when caused by SARS-CoV-2 variants of concern. In the US, the vaccine efficacy of 2 doses, 2 months apart, was 94%. In comparison, the single dose vaccine efficacy in the USA was 72%.
Furthermore, in the single dose trial the efficacy against symptomatic disease two months after vaccination had fallen to about 50%.
Ad26.COV2.S has an acceptable reactogenicity profile after both the first dose and second dose, with the reactogenicity post-second dose being similar or milder than post-dose 1.
Does it work against new variants of SARS-CoV-2 virus?
SAGE has reviewed all available data on the performance of the vaccine in the settings of the variants of concern. In clinical trials this vaccine has been tested against a variety of SARS-CoV-2 virus variants, including B1.351 (first identified in South Africa) and P.2 (first identified in Brazil), and found to be efficacious. There are no data yet for the performance of this vaccine against the Omicron variant.
SAGE currently recommends using this vaccine, according to the WHO Prioritization Roadmap, even if variants of concern are present in a country. As new data becomes available, WHO will update recommendations accordingly.
Interchangeability between vaccine products and platforms
When a second dose is given, it is currently recommended that the same product should be used for both doses.
Evolving evidence suggests that heterologous COVID-19 vaccine schedules (using WHO EUL vaccine products from different platforms) may be more immunogenic and effective than homologous schedules, depending on the specific platforms and order of the products used.
In particular, data shows that individuals who have received one dose of the Janssen vaccine followed by a second dose of mRNA vaccine have higher neutralising antibody concentrations than individuals who received two doses of the Janssen vaccine.
Studies also show that the Janssen vaccine is as effective in boosting antibodies as a homologous third dose of mRNA vaccine when given six months after a primary two-dose series of mRNA vaccine.
Co-administration with inactivated influenza vaccines
COVID-19 vaccines may be given concomitantly, or any time before or after, other adult vaccines including inactivated influenza vaccines. Different arms for injection should be used when both vaccines are delivered during the same visit. Continued pharmacovigilance monitoring is recommended.
Does it prevent infection and transmission?
There is currently no substantive data available related to the impact of Ad26.COV2.S on transmission of virus that causes COVID-19 disease.
In the meantime, we must maintain and strengthen public health measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds and ensuring good ventilation.
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