EMA starts rolling review of corona vaccine from Janssen

02 December 2020

The European Medicines Agency, EMA, has started a rolling review of data from the clinical trials of a potential COVID-19 vaccine from the manufacturer Janssen. The EMA has previously started the same process for other potential vaccines from AstraZeneca, BioNTech/Pfizer and Moderna.

The EMA has started a rolling review of a potential COVID-19 vaccine from vaccine manufacturer Janssen. The rolling review has been started to ensure readiness and to save administrative time in the review process without compromising the requirements for the documentation of the vaccine’s efficacy and safety.

The EMA has previously started rolling reviews of potential COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna.

In a rolling review, data from the various phases of development are assessed as they become available. Under normal conditions, this assessment would not be started before all data had been obtained.

Preliminary assessments cannot form the basis for the final conclusion

The data which the EMA has started reviewing are data from the first laboratory studies. These data cannot form the basis for a final conclusion on the vaccine’s efficacy and safety. The EMA will not come to any final conclusion about the vaccine before the data from the final phases of vaccine development have been obtained and thoroughly assessed – in line with the EMA’s customary high standards for assessment of quality, safety and efficacy.

The EMA’s decision to start a rolling review of Janssen’s potential vaccine is based on preliminary results from laboratory studies, animal trials and early clinical studies in human subjects. These results so far suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus.

Vaccine is now being tested in comprehensive trials with human subjects

Major clinical trials with several thousands of human subjects are being conducted right now to test the vaccine from Janssen. It is presently unknown when the results of these trials will be available.

Further reading:

EMA’s press release: EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S

16 November (17 November in English): News on the website of the Danish Medicines Agency: EMA starts rolling review of corona vaccine from Moderna

6 October: News on the website of the Danish Medicines Agency: A rolling review of one more potential COVID-19 vaccine has started.

1 October: News on the website of the Danish Medicines Agency EMA starts rolling review of a potential COVID-19 vaccine

COVID-19 theme on the website of the Danish Medicines Agency: Vaccines and medicines against COVID-19.

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