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EMA
recommends Valneva’s COVID-19 vaccine for authorisation in the EU |
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EMA has recommended granting a
marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted)
Valneva for use in the primary vaccination of people from 18 to 50 years of
age. COVID-19 Vaccine (inactivated,
adjuvanted) Valneva contains inactivated (killed) whole particles of the
original strain of SARS-CoV-2 that cannot cause disease. It is the sixth
vaccine recommended in the EU for protecting against COVID-19 and, together
with the vaccines already authorised, will support vaccination campaigns in EU
Member States during the pandemic. After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality. The main study conducted with
Valneva’s vaccine is an immunobridging trial. Immunobridging trials compare
the immune response induced by a new vaccine with that induced by an
authorised comparator vaccine proven to be effective against the disease. Results from the study, which
involved nearly 3,000 people aged 30 years and older, showed that the vaccine
triggers the production of higher levels of antibodies against the original
strain of SARS-CoV-2 than the comparator, Vaxzevria. In addition, the
proportion of people who produced a high level of antibodies was similar for
both vaccines. Additional data from this study
also showed that the vaccine is as effective at triggering the production of
antibodies in people aged between 18 and 29 as it is in people aged 30 years
and older. The CHMP therefore concluded
that COVID-19 Vaccine (inactivated, adjuvanted) Valneva is expected to be at
least as effective as Vaxzevria at protecting against the disease. Based on
the data provided, it was not possible to draw any conclusion on the immunogenicity
of Valneva’s vaccine (its ability to trigger the production of antibodies) in
people above 50 years of age; therefore, the vaccine is currently recommended
only for use in people between 18 and 50 years of age. There are limited data on the
immunogenicity of COVID-19 Vaccine (inactivated, adjuvanted) Valneva against
variants of concern, including Omicron subvariants which are currently the
dominant strains in many EU countries. The side effects observed with
COVID-19 Vaccine (inactivated, adjuvanted) Valneva in studies were usually
mild and cleared within a couple of days after vaccination. The most common
ones were tenderness or pain at the injection site, tiredness, headache,
muscle pain and nausea (feeling sick) or vomiting. 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 CHMP concluded that the benefits of COVID-19 Vaccine
(inactivated, adjuvanted) Valneva outweigh its risks and recommended granting
a standard marketing authorisation in the EU. Standard marketing authorisation The dossier for the vaccine
includes the results from an immunobridging trial. Although efficacy
placebo-controlled trials have been the gold standard for authorising
COVID-19 vaccines so far, EMA considers that a well-justified and
appropriately designed immunobridging study is adequate for authorising
future COVID-19 vaccines at this point in the pandemic. This is because there
are now a number of COVID-19 vaccines authorised in the EU that are proven to
be safe and effective and that can be used as comparators in studies.
Additionally, at present, it would be difficult to recruit enough individuals
who have not been vaccinated nor previously exposed to the virus to conduct
large efficacy clinical trials. The European Commission will
now fast-track the decision-making process to grant a decision on the
standard marketing authorisation for COVID-19 Vaccine (inactivated,
adjuvanted) Valneva, allowing this vaccine to be included in vaccination
programmes rolled out across the EU. A standard marketing authorisation is
considered appropriate for this vaccine since the immunobridging study met
its objectives and data provided are considered sufficient. Where
to find more information The product
information for COVID-19 Vaccine (inactivated, adjuvanted) Valneva
contains information for healthcare professionals, a package
leaflet for members of the public and details of the vaccine’s
authorisation. An
assessment report with details of EMA’s evaluation of COVID-19 Vaccine
(inactivated, adjuvanted) Valneva and the full risk
management plan will be published shortly. Clinical
trial data submitted by the company in the application for marketing
authorisation will be published on the Agency’s clinical
data website in due course. More
information is available in an overview
of the vaccine in lay language, including a description of the vaccine’s
benefits and risks and why EMA recommended its authorisation in the EU. How
COVID-19 Vaccine (inactivated, adjuvanted) Valneva works COVID-19 Vaccine (inactivated,
adjuvanted) Valneva works by preparing the body to defend itself against
COVID-19. The vaccine contains whole particles of the original strain of SARS-CoV-2
that has been inactivated (killed) and cannot cause the disease. It also
contains two ‘adjuvants’, substances that help strengthen the immune
responses to the vaccine. When a person is given the
vaccine, their immune system identifies the inactivated virus as foreign and
makes antibodies against it. If, later on, the vaccinated person comes into
contact with SARS-CoV-2, the immune system will recognise the virus and be
ready to defend the body against it. COVID-19 Vaccine (inactivated,
adjuvanted) Valneva is given as two injections, usually into the muscle of
the upper arm, 28 days apart. Monitoring the safety of COVID-19 Vaccine
(inactivated, adjuvanted) Valneva In line
with the EU’s safety monitoring plan for COVID-19 vaccines, COVID-19
Vaccine (inactivated, adjuvanted) Valneva will be closely monitored and
subject to several activities that apply specifically to COVID-19 vaccines.
Although large numbers of people have received COVID-19 vaccines in clinical
trials, certain side effects may only emerge when millions of people are
vaccinated. The company
is required to provide monthly safety reports in addition to the regular
updates required by legislation. In addition, independent studies of COVID-19 vaccines coordinated
by EU authorities will give more information on the vaccine’s long-term
safety and benefits in the general population. These
measures will allow regulators to swiftly assess data emerging from a range
of different sources and take any necessary regulatory action to protect
public health. Assessment of COVID-19 Vaccine
(inactivated, adjuvanted) Valneva During the
assessment of COVID-19 Vaccine (inactivated, adjuvanted) Valneva, the CHMP
had the support of EMA’s safety committee, the PRAC, who assessed the risk
management plan of the vaccine, and the COVID-19 EMA pandemic task force (COVID-ETF), a group
that brings together experts from across the European
medicines regulatory network to facilitate rapid and coordinated
regulatory action on medicines and vaccines for COVID-19. COVID-19
Vaccine (inactivated, adjuvanted) Valneva was evaluated as part of ‘OPEN’, an initiative started in
December 2020 with the aim of increasing international collaboration in the
EU review of COVID-19 vaccines and therapeutics. More information can be
found on the EMA’s governance during COVID-19 pandemic webpage. (AP) |
