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The Com­mit­tee for Medic­i­nal Prod­ucts for Hu­man Use at the EMA Rec­om­mends Au­tho­ri­sa­tion of Val­ne­va's In­ac­ti­vat­ed, Ad­ju­vant­ed, Whole Virus COVID-19 Vac­cine

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended on 23 June 2022 that Valneva's COVID-19 vaccine be given a standard marketing authorisation. The authorisation is valid for the first vaccination of persons aged 18 to 50 years. The vaccine contains inactivated (killed) whole virus particles of the original strain of SARS-CoV-2, which cannot cause the disease. Valneva is the sixth vaccine recommended in the EU to protect against COVID-19. It is expected that the EU Commission will decide on the authorisation of this COVID-19 vaccine in a timely manner. Valneva can be then be included in vaccination programmes and administered throughout the EU.

COVID-19 Vaccine Ampoules (Source: Thorsten Simon/pixabay.com)

After a thorough evaluation, the CHMP concluded that the data on Valneva's COVID-19 vaccine meet the quality, safety and efficacy criteria for an initial COVID-19 vaccine authorisation at this stage of the pandemic.

Authorisation Trial – Immunobridging Trial with Almost 3,000 Participants

The main study conducted with Valneva's COVID-19 vaccine is an immunobridging trial. In an immunobridging trial, the immune response induced by a new vaccine is compared with that induced by an authorised comparator vaccine that has been proven to be effective against the infectious disease. In the case of Valneva's COVID-19 vaccine, the applicant chose a comparison with the adenovirus vector vaccine Vaxzevria.

The results of the immunobridging trial, in which nearly 3,000 people aged 30 years and older participated, showed that the Valneva vaccine produced a higher antibody titre (antibody concentration in blood/serum) against the SARS-CoV-2 original strain than Vaxzevria (immunogenicity test). In addition, the proportion of subjects with high antibody titres was similar for both vaccines.

Further data from this study showed that the Valneva vaccine produced antibodies in subjects aged between 18 and 29 years of age in a comparable way to subjects aged 30 years and older.

The CHMP concluded that Valneva's COVID-19 vaccine is expected to be at least as effective as Vaxzevria in protecting against COVID-19.

No Conclusions on Immunogenicity in Persons over 50 Years of Age and against Variants of Concern

The data presented did not allow conclusions to be drawn on the immunogenicity of this vaccine in subjects over 50 years of age. Therefore, the vaccine is currently only recommended for use in people aged between 18 and 50 years.

Data on the immunogenicity of Valneva's COVID-19 vaccine against new variants is limited. This also applies to the Omicron subvariants, which are currently dominant in many EU countries.

Mild Side Effects Only

Adverse reactions observed between the start of the study observation periods and the start of data analysis with Valneva's COVID-19 vaccine were usually mild and resolved within a few days after vaccination. The most common side effects were sensitivity or pain at the injection site, fatigue, headache, muscle pain and nausea or vomiting.

The safety and efficacy of the vaccine will continue to be monitored through the EU pharmacovigilance system and additional studies conducted by the manufacturer and the EU national medicines authorities as part of the EU-wide use of the vaccine.
Based on the available data, the CHMP concluded that the benefits of Valneva's COVID-19 vaccine outweigh its risks and recommended that a standard EU marketing authorisation be granted.

Authorisation

The vaccine dossier contains the results of an immunobridging trial. Although placebo-controlled efficacy trials have so far been the gold standard for the authorisation of COVID-19 vaccines, the CHMP is of the opinion that a well-founded and appropriately designed immunobridging trial is sufficient for the authorisation of future COVID-19 vaccines at this stage of the pandemic.

Authorisation is considered appropriate for this vaccine as the objectives set in the immunobridging trial have been achieved and the data submitted for this purpose is considered sufficient. The possibility of replacing immunobridging trials as a substitute for efficacy trials has come up, as a number of COVID-19 vaccines are now approved in the EU that have proven to be safe and effective and can be used as reference material in trials. It would also be difficult at present to recruit enough individuals who have not been vaccinated or previously exposed to the virus to conduct extensive clinical efficacy trials.

How Does Valneva's COVID-19 Vaccine Work?

The vaccine contains inactivated whole virus particles from the original strain of SARS-CoV-2. The viruses were inactivated (killed) so that they cannot cause the disease and cannot multiply. In addition, the vaccine contains two adjuvants, substances that increase the immune response to the vaccine.

The COVID-19 vaccine from Valneva is given as two injections at an interval of 28 days, usually into the muscle of the upper arm.

Updated: 24.06.2022