Janssen-Cilag AG applies to have its vaccine candidate authorised
Bern, 07.12.2020 - Swissmedic is examining Janssen’s COVID-19 vaccine in a rolling submission procedure Last week the pharmaceutical company Janssen-Cilag, which is part of the Johnson & Johnson Group, submitted an application to Swissmedic to have its vaccine candidate Ad26.COV2.S authorised. Almost simultaneously, Janssen also submitted applications to have the vector-based vaccine authorised in Europe and Canada.
As with the previous applications, Swissmedic is examining this candidate in a greatly accelerated process. In this “rolling procedure”, companies submitting an authorisation application do not have to wait until all the necessary documentation has been completed but can submit results from ongoing studies as soon as they become available. In this way, Swissmedic may under certain circumstances be able to reach a decision on initial authorisation so that the Swiss population can swiftly gain access to effective vaccines of impeccable quality.
The Janssen COVID-19 vaccine candidate Ad26.COV2.S is a recombinant viral-vector vaccine based on a human adenovirus. The company uses this same platform to develop and produce other vaccines. Vector viruses trigger the production of antibodies to the new coronavirus in human immune cells.
Having received this latest application for authorisation, Swissmedic is now examining four COVID-19 vaccine candidates. The vaccine manufacturers decide whether – and, if so, when – they will apply to Swissmedic to have their product authorised. As Swissmedic has been planning the authorisation process for coronavirus vaccines for some months now, the necessary staff resources for testing them scientifically have been properly planned and allocated.
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