July 20, 2021 The Committee for the Evaluation of Medicinal Products (CHMP) of EMA,
the European Medicines Agency,
has initiated a review of Vidprevtyn, a vaccine against Covid-19 developed by
The CHMP's decision to initiate the ongoing review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults, which suggest that the vaccine triggers the production of antibodies to SARS-CoV-2, the virus that causes Covid-19, and can help protect against disease.
The EMA, underlines a note from the Agency, will evaluate the data as soon as they become available to decide whether the benefits outweigh the risks. The review will continue until sufficient evidence is available for a formal marketing authorization application.
Then Ema will assess Vidprevtyn's compliance with the usual EU standards for efficacy, safety and quality. While I cannot predict the overall timeline, it should take less time than usual to evaluate a possible request.
Vidprevtyn, he explains, is supposed to prepare the body to defend itself against SARS-CoV-2 infection. It is a
protein-based vaccine that contains a lab-grown version of the Spike protein,
found on the surface of SARS-CoV-2. It also contains
a substance that helps boost
to the vaccine.
On 18 September 2020, the
signed a pre-purchase agreement with the French pharmaceutical company and the British Gsk, the second contract signed by the EU executive after the one with AstraZeneca, to purchase up to 300 million doses. The trial had not initially yielded satisfactory results and the Franco-British vaccine process had stopped.