2023-07-19 10:41:03
Bern (awp / ats) – After that of Moderna, Swissmedic is examining a second updated monovalent vaccine against Covid-19. Pfizer has applied for marketing authorization for its product, the Swiss Institute for Therapeutic Products announced on Wednesday.
Swissmedic will review the vaccine against Omicron XBB.1.5 subvariant of SARS-CoV-2. It is an internationally harmonized regulatory procedure for the simplified authorization of new vaccines, for which a minimal update of the strain of an already authorized COVID-19 vaccine has been carried out, writes Swissmedic in a statement.
This procedure was set up under the aegis of the World Health Organization (WHO). In particular, it has been used for decades for the annual authorization of suitable influenza vaccines, which does not require the submission of clinical data at the time of authorization.
The procedure foresees that the applicant subsequently submits empirical data which will be examined by Swissmedic. In the future, the update of the Covid-19 strain will be carried out once a year, in the spring, on the recommendation of the WHO.
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