The Ema (European Medicines Agency) has recommended authorizing the Covid VidPrevtyn Beta vaccine, manufactured by Sanofi Pasteur, as a booster in adults previously vaccinated with an mRna vaccine or adenoviral vector. VidPrevtyn Beta contains a version of the spike protein found on the surface of the Beta variant of the Sars-CoV-2 virus. It also contains an ‘adjuvant’, a substance to help boost immune responses to the vaccine.
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EMA’s Committee for Medicinal Products for Human Use concluded that sufficiently robust data on the quality, safety and immunogenicity of the vaccine are now available to recommend its marketing authorization in the EU.
The main studies conducted with VidPrevtyn Beta are two immunobridging, which compare the immune response induced by this new vaccine with that induced by a licensed comparator vaccine effective against the disease. The first involved 162 people aged 18 and over who were given a booster of VidPrevtyn Beta or the comparator vaccine (the first version of BioNTech-Pfizer’s Comirnaty vaccine). The study showed that a booster dose of VidPrevtyn Beta triggers higher antibody production against the Sars-CoV-2 Omicron BA.1 sub-variant compared to Comirnaty.
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In a second work, a booster injection with VidPrevtyn Beta restored immunity against several variants of the Sars-CoV-2 virus, in 627 people aged 18 and over who had previously completed a primary vaccination course with an mRna vaccine (Comirnaty or Spikevax) or an adenoviral vector vaccine (Vaxzevria or Jcovden). The most common side effects seen with VidPrevtyn Beta in studies were pain at the injection site, headache, muscle or joint pain, generally feeling unwell and chills. But these were generally minor consequences and disappeared within a couple of days after vaccination.