On 15 December 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended the authorisation of booster vaccinations for people 18 years of age and older with COVID-19 Vaccine Janssen (Johnson & Johnson). The booster was recommended after previous vaccination with COVID-19 Vaccine Janssen (homologous booster vaccination) or after basic immunisation with authorised mRNA COVID-19 vaccines (heterologous booster vaccination). A decision by the European Commission on whether to follow the recommendation is expected soon.
After evaluating the data, the CHMP has concluded that a booster dose of COVID-19 Vaccine Janssen can be authorised and thus considered for booster vaccinations for those 18 years of age or older who received their first dose of COVID-19 Vaccine Janssen at least two months prior.
The data submitted shows that a booster dose of COVID-19 Vaccine Janssen given no earlier than two months after the first dose of COVID-19 Vaccine Janssen in adults results in an increase in antibodies to SARS-CoV-2. The risk level of thrombosis in combination with thrombocytopenia (TTS) or other very rare side effects following homologous booster vaccination is not yet known and will be carefully monitored.
The CHMP also supported the authorisation of a booster vaccination with COVID-19 Vaccine Janssen at least six months after basic immunisation with two doses of one of the mRNA vaccines licensed in the EU, Comirnaty (Pfizer/BioNTech) or Spikevax (Moderna).
Taking into account the local epidemiological situations, vaccine availability and emerging information on efficacy, as well as the limited safety data for booster vaccination, health authorities at the national level may make official recommendations for the use of booster doses, either after one dose of COVID-19 Vaccine Janssen or after two doses of one of the EU-approved mRNA vaccines.
The COVID-19 vaccine from Janssen is a vector vaccine. It consists of an innocuous, non-replicable vector virus from the human adenovirus family (cold viruses). The virus has been modified so that its genome contains the gene for the production of the SARS Coronavirus 2 spike protein. The SARS Coronavirus 2 needs this surface protein to invade certain body cells. After vaccination, the vaccine introduces the SARS-CoV-2 spike protein gene into the body's cells. The cells read the gene and produce the spike protein for a limited time. The immune system recognises this protein as foreign, produces antibodies, and activates the cellular immune system (white blood cells) to render the virus harmless and eliminate infected cells. If a vaccinated person later comes into contact with the SARS-CoV-2 virus, their immune system will recognise and fight the spike proteins on the virus and on virus-infected cells.
Basic immunisation with the COVID-19 Vaccine Janssen requires a single dose in persons 18 years of age and older, according to the authorisation. However, the Standing Committee on Vaccination (Ständige Impfkomission, STIKO) currently recommends optimising vaccination protection by an additional vaccination with an mRNA vaccine (Comirnaty or Spikevax), whereby Spikevax should not be used for those under 30 or pregnant. In addition, the STIKO recommends a booster vaccination with an mRNA vaccine for all persons aged 18 years and older, usually at an interval of 6 months from the last vaccine dose of the basic immunisation. Spikevax should not be used for those under 30 or pregnant in this case as well.
Updated: 16.12.2021
