It is the previous step to the marketing authorisation
EMA’s human medicines committee (CHMP) has started a rolling review of the vaccine against Covid-19 of the biotechnological pharmaceutical company HIPRA. The HIPRA’s Covid-19 bivalent vaccine is based on an adjuvant recombinant protein and it has been developed as a booster dose for fully vaccinated adults.
The CHMP’s decision to start the rolling review is based on preclinical development and preliminary results obtained in the clinical studies. The clinical studies compared the immune response generated by the vaccine (measured by the level of neutralizing antibodies against SARS-CoV-2) with that seen with an mRNA vaccine (Comirnaty). The preliminary results suggest that the immune response is effective against SARS-CoV-2, including variants of concern such as Omicron.
EMA, through the rolling review, will evaluate exiting data of the HIPRA’s vaccine and those generated up to the marketing authorisation, following the usual EU standards for effectiveness, safety and quality. HIPRA estimates that the conditional marketing authorization can be received between the end of May and the beginning of June. The company is already prepared at the production level to have the vaccine available in a few days.
About HIPRA’s Vaccine
The bivalent vaccine against Covid-19 developed by HIPRA is an adjuvant recombinant protein vaccine, based on a receptor-binding domain fusion heterodimer (RBD) containing the B.1.1.7 (Alpha) and B.1.351 (Beta) variants of SARS-CoV-2.
The HIPRA vaccine is stored at refrigerated temperature between 2 and 8 oC, making its storage and distribution easier. The technology used allows great versatility to adapt it to new variants of the virus, if necessary, in the future. The results obtained show that a booster dose of HIPRA vaccine generates an immune response equal to or greater than that generated with a booster dose of Comirnaty against Beta, Delta and Omicron variants, which predicts a high capacity for protection against of the disease.
A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency. Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorisation. In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available and once enough data are available, the company can submit a formal application. This rolling review allows the marketing authorization for the medicine to be obtained in a shorter time than usual.