EMA recommends approval of VidPrevtyn Beta as a Covid-19 booster vaccine
The European Medicines Agency (EMA) said on November 10 that its human medicines committee had recommended authorising the VidPrevtyn Beta vaccine against Covid-19 as a booster in adults previously vaccinated with an mRNA or adenoviral vector Covid-19 vaccine.
VidPrevtyn Beta, developed by Sanofi Pasteur, 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 strengthen the immune responses to the vaccine, the EMA said.
The agency’s human medicines committee concluded that sufficiently robust data on the quality, safety and immunogenicity of the vaccine are now available to recommend its marketing authorisation in the EU.
The main studies conducted with VidPrevtyn Beta are two immunobridging trials, which compare the immune response induced by this new vaccine with that induced by an authorised comparator vaccine effective against the disease.
The first trial involved 162 people aged 18 years and older, who were given a booster of VidPrevtyn Beta or the comparator vaccine (the originally authorised Comirnaty vaccine targeting the wild-type SARS-CoV-2 spike protein).
The study showed that a booster dose of VidPrevtyn Beta triggers a higher production of antibodies against the SARS-CoV-2 Omicron BA.1 subvariant than Comirnaty.
In a second main study, a booster injection with VidPrevtyn Beta restored immunity against different SARS-CoV-2 virus variants in 627 people aged 18 and older who had previously completed a primary vaccination course with an mRNA vaccine (Comirnaty or Spikevax) or an adenoviral vector vaccine (Vaxzevria or Jcovden).
The EMA human medicines committee concluded that a booster dose of VidPrevtyn Beta is expected to be at least as effective as Comirnaty at restoring protection against Covid-19.
The most common side effects observed with VidPrevtyn Beta in studies were pain at the injection site, headache, muscle or joint pain, feeling generally unwell and chills. These were usually mild and cleared within a couple of days after vaccination, the EMA said.
The safety and effectiveness of the vaccine will continue to be monitored as the vaccine is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.
Based on the available evidence, the human medicines committee concluded that the benefits of VidPrevtyn Beta outweigh its risks and recommended granting a standard marketing authorisation in the EU, the EMA said.
(Photo: Bulgarian Military Medical Academy)
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