The Committee for Medicinal Products for Human Use (CHMP) of the EMA concluded that a booster dose of Janssen COVID-19 vaccine may be administered to persons aged 18 years and over at least 2 months after the first dose.
The recommendation is made on the basis of data showing that administration of a booster dose of COVID-19 Janssen vaccine to adults at least 2 months after the first dose resulted in an increase in levels of antibodies against SARS-CoV-2 (the virus that causes COVID-19 disease). The risk of thrombosis associated with thrombocytopenia (TTS) or other very rare adverse reactions following booster dosing is not known and is being carefully monitored.
The CHMP also concluded that a booster dose with Janssen COVID-19 vaccine may be administered after two doses of one of the EU licensed mRNA vaccines, Comirnaty (from Pfizer/BioNTech) or Spikevax (from Moderna).
As for all medicines, the EMA will continue to review all data on the safety and efficacy of the COVID-19 Janssen vaccine.
At the national level, public health authorities may issue formal recommendations on the use of booster doses, following the administration of either one dose of COVID-19 Janssen vaccine or two doses of mRNA vaccines, taking into account the local epidemiological situation, the availability of vaccines, the resulting efficacy data and the limited safety data on the booster dose.
Data supporting the booster dose recommendation for the COVID-19 Janssen vaccine will be available in the updated product information.
National immunisation campaigns
The implementation of vaccination campaigns in the EU remains the prerogative of the National Immunisation Technical Advisory Groups (NITAGs) which guide the vaccination campaigns in each EU Member State. These bodies are best placed to take into account local circumstances, including the spread of the virus (in particular any variants of concern), the availability of vaccines and the capacity of national health systems.
The EMA will continue to work closely with national authorities and the European Centre for Disease Prevention and Control (ECDC) to assess available data and provide recommendations to protect the public during the current pandemic.
(AF)
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