No data on efficacy against current Covid variants – but European watchdog wants standard approval for Valneva

RIO DE JANEIRO, BRAZIL – It is the sixth Covid vaccine to be approved in the EU: The European Medicines Agency EMA has recommended approval for Valneva’s vaccine (VLA2001); approval by the EU Commission is considered a mere formality.

It is interesting to note that a lot of data on the vaccine is not available – but instead of conditional approval, they would still like to allow a standard approval directly. This vaccine also uses gene therapy.

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The EMA considers a study with not even 3,000 participants to be significant enough to recommend standard approval.

This is not a placebo-controlled trial, as is actually considered the gold standard for efficacy studies, but merely an immunobridging study comparing the immune response to Valneva’s vaccine with that to AstraZeneca’s controversial vector vaccine.

In the study, antibody production was reportedly higher in Valneva vaccinees – but only against the original strain of SARS-CoV-2, which has not been widely used for a long time. Data are lacking on efficacy against omicron. In terms of how many vaccinees responded with high antibody responses after the shot, the two vaccines showed little difference.

The recommendation for approval applies to persons between 18 and 50 years of age; there are also no meaningful data for persons over 50 years of age.

As originally reported for the mRNA and vector vaccines, the only known side effects to date are pain at the injection site, fatigue, headache, muscle pain, and nausea/vomiting.

The Valneva vaccine is an inactivated whole-virus vaccine that relies on two adjuvants at once – alum and CpG 1018, the latter of which is synthetic DNA and therefore gene therapy. It is therefore wrong, according to experts, to call the vaccine a traditional dead vaccine.

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