The EMA’s Committee for Human Drugs (CHMP) has concluded that a booster dose of Janssen COVID-19 vaccine can be given at least 2 months after the first dose to people 18 years of age and older.
The recommendation follows data showing that a booster dose of Janssen vaccine, given at least 2 months after the first dose in adults, led to an increase in antibodies to SARS-CoV-2. The risk of thrombosis in combination with thrombocytopenia (TTS) or other very rare side effects after booster dose is not known and is closely monitored.
The CHMP also concluded that a booster dose with the Janssen vaccine could be given after two doses of mRNA vaccines approved in the EU, Comirnaty (by Pfizer / BioNTech) or Spikevax (by Moderna).
As with all medicines, the EMA will continue to review all data on the safety and efficacy of the Janssen vaccine.
At national level, public health bodies can issue formal recommendations for booster use, either after a single dose of Janssen vaccine or after two doses of mRNA vaccines, taking into account the local epidemiological situation, the availability of vaccines, the emerging efficacy and limited safety data for the booster dose.
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