The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended licensing VidPrevtyn Beta vaccine as a booster dose in adults previously vaccinated with mRNA or adenoviral vector vaccine against Covid-19 disease.
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 "immune enhancer", a substance that helps boost immune responses to the vaccine.
The EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that sufficient reliable data on the quality, safety and immunogenicity of the vaccine are available to recommend marketing authorisation in the EU.
The main studies conducted with VidPrevtyn Beta are two immunografting trials, which compare the immune response induced by this new vaccine against a licensed comparator vaccine that has been shown to be effective against the disease.
The first trial included 162 subjects aged 18 years and older who were given a booster dose of VidPrevtyn Beta or the comparator vaccine (the licensed Comirnaty prototype vaccine targeting the wild-type SARS-CoV-2 spike protein). The study showed that a booster dose of VidPrevtyn Beta triggers the production of higher levels of antibodies against the SARS-CoV-2 sub variant Omicron BA.1 compared to Comirnaty.
In the second main study, a booster dose of VidPrevtyn Beta restored immunity against different SARS-CoV-2 virus variants in 627 subjects aged 18 years and older who had previously completed the initial vaccination regimen with an mRNA vaccine (Comirnaty or Spikevax) or an adenoviral vector vaccine (Vaxzevria or Jcovden).
Therefore, the CHMP concluded that a booster dose of VidPrevtyn Beta is expected to be at least as effective as Comirnaty in restoring protection against COVID-19.
The most common adverse reactions observed with VidPrevtyn Beta in the studies were injection site pain, headache, muscle or joint pain, general malaise and chills. These adverse reactions were usually mild and resolved within two days after vaccination.
The safety and efficacy of the vaccine will continue to be monitored as the vaccine is used throughout the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.
Based on the available evidence, the CHMP concluded that the benefits of VidPrevtyn Beta outweigh the risks associated with it, and recommended that a standard marketing authorisation be granted in the EU.
Standard marketing authorisation
The vaccine dossier includes the results of two immunografting trials. Although placebo-controlled efficacy trials have so far been the standard for the licensing of COVID-19 vaccines, the EMA considers that at this point in the pandemic, a well-justified and appropriately designed immunografting study is sufficient for the licensing of future COVID-19 vaccines. This is because there are now EU licensed vaccines against COVID-19 that have been shown to be safe and effective and can be used for comparison in studies. In addition, at present, it would be difficult to recruit enough people who have not been vaccinated or previously exposed to the virus to conduct large clinical efficacy trials.
The European Commission will now expedite the decision making process on the standard marketing authorisation for the VidPrevtyn Beta vaccine, allowing for the inclusion of this vaccine in the vaccination programmes that have been developed across the EU. A standard marketing authorisation is considered appropriate for this vaccine as the immunografting study met its objectives and the data submitted are considered sufficient.
Where to find more information
The product information for VidPrevtyn Beta vaccine contains information for healthcare professionals, a package leaflet for the public and details on the licensing of the vaccine.
The assessment report detailing the EMA assessment of VidPrevtyn Beta vaccine and the full risk management plan will be published shortly. The clinical trial data submitted by the company in the marketing authorisation application will be published on the Agency's clinical data website in due course.
More information is available in a plain language summary of the vaccine, including a description of the benefits and risks of the vaccine and the reasons why the EMA recommended its licensing in the EU.
How the VidPrevtyn Beta vaccine works
VidPrevtyn Beta works by preparing the body to defend itself against COVID-19 disease. The vaccine contains a laboratory-generated version of the spike protein found on the surface of the SARS-CoV-2 Beta variant. It also contains an "immune booster," a substance that helps boost immune responses to the vaccine.
When a person is given the vaccine, their immune system will recognize these proteins as foreign and activate natural defenses - antibodies and T cells - against them. If, later, the vaccinated person comes into contact with the virus, the immune system will recognise the spike proteins on its surface and be ready to attack the virus. The immune system's antibodies and cells can protect against COVID-19 disease by killing the virus through synergy, preventing it from entering the body's cells and destroying the infected cells.
The booster dose of VidPrevtyn Beta is usually administered to the upper arm muscle.
Monitoring the safety of VidPrevtyn Beta vaccine
In accordance with the EU safety monitoring plan for COVID-19 vaccines, VidPrevtyn Beta vaccine will be closely monitored and will be subject to several activities specific to COVID-19 vaccines. Although a large number of individuals have received COVID-19 vaccines in clinical trials, some adverse reactions may occur only after millions of individuals have been vaccinated.
The company is required, in addition to the regular updates required by legislation, to submit monthly safety reports. In addition, independent studies on COVID-19 vaccines coordinated by EU authorities will provide more information on the long-term safety and benefits of the vaccine in the general population.
These measures will allow regulators to quickly assess data from a range of different sources and take any necessary regulatory action to protect public health.
Evaluation of VidPrevtyn Beta vaccine
In evaluating VidPrevtyn Beta vaccine, the CHMP was supported by the EMA Safety Committee, PRAC, which evaluated the vaccine's risk management plan, as well as the COVID-19 EMA pandemic task force (COVID-ETF), a group that brings together experts from across the network of European regulators to facilitate rapid and coordinated action on COVID-19 medicines and vaccines.
The VidPrevtyn Beta vaccine was evaluated as part of "OPEN", an initiative launched in December 2020 to strengthen international collaboration in the EU-wide evaluation of COVID-19 vaccines and medicines. More information is available on the EMA governance during the COVID-19 pandemic
(AF)
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