The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended on 10 November 2022 that a marketing authorisation be issued for the COVID-19 booster vaccine VidPrevtyn Beta from Sanofi Pasteur. The EU Commission granted a marketing authorisation for the COVID-19 vaccine that same day.
After a thorough evaluation, the CHMP concluded that the data on the COVID-19 vaccine VidPrevtyn Beta meet the quality, safety and efficacy criteria for an initial COVID-19 vaccine authorisation for booster vaccination at this stage of the pandemic.
The evaluation was based on two clinical trials comparing the immune response induced by VidPrevtyn Beta after the third vaccination (booster) with that of an already authorised COVID-19 vaccine (immunobridging).
The first clinical trial involved 162 persons aged 18 or older. They received a booster dose of either VidPrevtyn Beta or the comparator vaccine Comirnaty, which targets the original form of the SARS-CoV-2 virus (Wuhan). This study showed that booster vaccination with VidPrevtyn Beta leads to higher concentrations (titres) of antibodies in the blood against the SARS-CoV-2 subvariant Omicron BA.1 than booster vaccination with the comparator vaccine.
The second clinical trial involved 543 persons aged 18 years and over who had previously received a primary vaccination course with an mRNA vaccine (two doses of Comirnaty or Spikevax) or an adenoviral vector vaccine (two doses of Vaxzevria or one dose of Jcovden). Booster vaccination with VidPrevtyn Beta significantly increased the immune response against various SARS-CoV-2 virus variants in all groups.
The most common side effects after booster vaccination with VidPrevtyn Beta were injection site pain, headache, muscle or joint pain, general discomfort and chills. These reactions were usually mild and were resolved within a few days of vaccination.
VidPrevtyn is – following the already authorised COVID-19 vaccine Nuvaxovid from Novavax – now the second protein-based COVID-19 vaccine which is authorised in the EU. It contains a cell culture-produced version of the SARS-CoV-2 spike protein and AS03, an adjuvant.
Updated: 11.11.2022
