Europe Begins Reviewing French COVID-19 Vaccine Candidate
The European Medicines Agency (EMA) confirmed today its human medicines committee (CHMP) had started a rolling review of Vidprevtyn, a COVID-19 vaccine candidate developed by Sanofi Pasteur.
France-based Sanofi and its development partner GSK have combined innovative technologies to produce Vidprevtyn.
Vidprevtyn is a protein-based vaccine expected to prepare the body to defend itself against infection from the SARS-CoV-2 beta coronavirus. It also contains an ‘adjuvant,’ a substance to help strengthen the immune responses to the vaccine.
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.
The rolling review will continue until enough evidence is available for a formal marketing authorization application. 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. The EMA will evaluate data to decide if the vaccine's benefits outweigh the risks.
Furthermore, the EMA will assess the compliance of Vidprevtyn with the usual EU standards for effectiveness, safety, and quality.
On July 8, 2021, Sanofi announced the Phase 3 study initiation.
The previous Phase 2 study results found the adjuvanted recombinant COVID-19 vaccine candidate achieved high neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates. In addition, after a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
Today, the Sanofi Company and its 100,000 employees are dedicated to making a difference in patients' daily lives, wherever they live, and enabling them to enjoy a healthier life. Sanofi, Synthélabo, Hoechst, Rhône-Poulenc Rorer led to the creation of Sanofi. These companies have accumulated over a century of experience in health, with a core concern of innovation to meet the evolution of society and the needs of patients.
The European Medicines Agency is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines.