European Medicines Agency evaluates French Valneva’s COVID vaccine in real time

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 that suggest that it triggers the production of antibodies that attack SARS-CoV-2, the virus that causes COVID-19.

This analysis process means that the agency will evaluate the data as it becomes available until it gathers enough information to decide whether the benefits of its approval and use against COVID-19 outweigh the risks of its possible side effects.

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, which may take a few months to arrive.

“The Agency will assess VLA2001’s compliance with the usual EU standards for 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 marketing authorization for the vaccine 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, their immune system identifies the inactivated virus as “strange”And produces antibodies against it, preparing it for future contacts with the coronavirus.

The European Commission (EC) approved on November 10 a contract with the pharmaceutical company Valneva to acquire next year 27 million doses of its vaccine against COVID-19 and have the right to buy an additional 33 million in 2023, always 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 Novavax, which “could be approved in a matter of weeks”, As announced by the executive director of the EMA, Emer Cooke, last Tuesday.