New COVID-19 vaccine may be granted marketing authorisation shortly

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The human medicines committee (CHMP) of the European Medicines Agency (EMA) has started a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva, the EU Amsterdam-based medicines watchdog has announced on Thursday.
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EMA’s human medicines committee (CHMP) has announced today that it started a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva. 

The CHMP's decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults.

These studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.

EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.

The Agency will assess the compliance of VLA2001 with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

EMA will communicate further when the marketing authorisation application for the vaccine has been submitted.

On 10 November, the European Commission approved the eighth contract with a pharmaceutical company with a view to purchasing its potential vaccine against COVID-19. The contract with Valneva provides for the possibility for all EU Member States to purchase almost 27 million doses in 2022.

THE AGREEMENT ALSO INCLUDES THE POSSIBILITY TO ADAPT THE VACCINE TO NEW VARIANT STRAINS,

and for Member States to make a further order of up to 33 million additional vaccines in 2023.

The contract with Valneva comes in addition to an already secured broad portfolio of vaccines to be produced in Europe, including the contracts already signed with

Valneva is a European biotechnology company developing an inactivated virus vaccine, made of the live virus through chemical inactivation.

This is a traditional vaccine technology, used for 60-70 years, with established methods and high level of safety. Most of the flu vaccines and many childhood vaccines use this technology.

THIS IS CURRENTLY THE ONLY INACTIVATED VACCINE CANDIDATE IN CLINICAL TRIALS AGAINST COVID-19 IN EUROPE.

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