Valneva | A new candidate vaccine against COVID-19 is evaluated by the EMA

The European Medicines Agency (EMA) began this Thursday to evaluate in real time the emerging data of the inactivated virus vaccine known as VLA2001, developed by the French pharmaceutical Valneva, which becomes the fifth preparation against COVID-19 that is analyzing this drug regulator.

The Committee for Medicinal Products for Human Use (CHMP) has initiated a process of “continuous review” of this vaccine based on the preliminary results of laboratory studies and the first clinical studies in adults suggesting that they attack SARS-CoV- 2, the virus that causes COVID-19.

This process of analysis means that the agency will evaluate the data as it becomes available until it gathers enough information to decide if the risks of its possible side effects outweigh it.

The review will continue until there is sufficient evidence available for the pharmacist to take the step of formally requesting a European license for the use of its vaccine in all European Union (EU) countries with the support of EMA experts, that

”The Agency will assess the compliance of VLA2001 with the usual EU standards regarding efficacy, safety and quality. While EMA cannot predict overall timelines, it should take less time than normal to evaluate an eventual (license) application due to the work involved during ongoing review ”, explains the agency.

The approval schedule will be clearer when the pharmaceutical company requests authorization from in the EU.

This vaccine prepares the body to defend itself against the spread of SARS-CoV-2 with the inactivated virus technology (which cannot cause disease) used in traditional vaccines, which have been used safely and effectively since the middle of the last century , for example, in flu vaccines.

This vaccine also contains two “adjuvants,” a substance that helps strengthen the immune response to an antigen. When a person receives the injection, his immune system identifies the inactivated virus as “against him, preparing him for future contacts with the coronavirus.

On November 10, the European Commission (EC) approved a contract with the pharmaceutical company Valneva to purchase 27 million doses of its COVID-19 vaccine next year and have the right to buy an additional 33 million in 2023, provided that the company obtains the approval of the EMA.

Three other vaccines are in the continuous evaluation phase at the CHMP: Russia’s Sputnik V, China’s Vero Cell, and France’s Vidprevty.

In a more advanced phase, because it has already requested the EMA’s endorsement of its license, there is the American vaccine, which “It could be approved in a matter of weeks”, as EMA Executive Director Emer Cooke announced last Tuesday.

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