European Medicines Agency begins rolling reviews of GSK & Sanofi’s COVID-19 vaccine

The EMA extends rolling reviews to fifth COVID-19 vaccine candidate after early data shows promise.

On Tuesday, the European medicines regulator announced it had commenced rolling reviews for the COVID-19 vaccine developed by GSK and Sanofi Pasteur. A 35,000-patient phase 3 trial for the vaccine called Vidprevtyn was started in May. According to the agency’s statement, “the decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults, which 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.” The EMA’s rolling reviews allows it to evaluate data as it becomes available to determine if the associated benefits outweigh the risks. These reviews are expected to “continue until enough evidence is available for a formal marketing authorisation application”.

Vidprevtyn leverages both companies’ proprietary technologies - being based on a recombinant protein antigen developed by the French giant’s vaccines unit Sanofi Pasteur and an immune-boosting adjuvant developed by GSK intended to boost its efficacy. The duo hope to obtain approvals by the end of the year – a likely occurrence after early-stage results showed the vaccine produces a robust immune response. This is the fifth candidate to be afforded these types of reviews by the EMA after the same was extended to CureVac, Novavax, Sinovac as well as Russia's Sputnik V. Thus far, only four COVID-19 vaccines have been approved in the EU, including two mRNA-based candidates from Moderna and Pfizer/BioNTech, as well as two other candidates based on adenoviral vectors manufactured by AstraZeneca and Johnson & Johnson.