EMA launches evaluation of HIPRA, Spanish vaccine against COVID-19

The European Medicines Agency (EMA) has launched an evaluation of HIPRA, a Spanish vaccine against COVID-19, as a first step towards its future authorization. This was announced this Tuesday by a community body that said the EMA Human Medicine Committee (CHMP) had launched an ongoing review of HIPRA (also known as PHH-1V). This protein-based vaccine was developed by HIPRA Human Health SLU as a booster vaccine for adults with a full vaccination schedule.

CHMP decision to launch ongoing review “Based on preliminary results of laboratory tests (non-clinical data) and clinical trials in adults,” EMA reports: Pfizer’s Comirnaty mRNA vaccine. Preliminary results suggest that the immune response with the Hipra COVID-19 vaccine may be effective against SARS-CoV-2, including severe variants such as Omicron.

“The EMA will evaluate the data when it becomes available to determine whether the benefits outweigh the risks,” the agency said. The EMA will assess the suitability of the vaccine. HIPRA meets EU standards on efficiency, safety and quality. While the EMA is unable to predict the overall timing, this should take less time than usual due to the work done during the ongoing review. ”

The Catalan company is working on two recombinant protein vaccines of the coronavirus alpha and beta variants, which will trigger an immune response to the so-called.Spike SARS-CoV-2, similar to the technology used in American Novavax. In addition, another noteworthy feature of the project is that it is a product that can be stored at 2 to 8 degrees, which will facilitate its distribution and logistics.

“When a person gets the vaccine,” explains the EMA, “their immune system recognizes the two proteins in the vaccine as foreign and develops natural defenses (antibodies and T cells) against them. If a vaccinated person is subsequently exposed to SARS-CoV-2, the immune system will recognize the virus protein and be ready to attack it. Antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent it from entering the body’s cells, and destroy infected cells.

The current EMA review that Hypra is undergoing is a regulatory tool that will speed up the evaluation of a drug or vaccine in the event of a public health emergency such as a corovirus pandemic. Normally, all data on the efficacy, safety, and quality of a drug or vaccine and all required documentation should be ready at the beginning of the evaluation in the official marketing authorization application. In the case of an ongoing review, the Human Medicines EMA Committee (CHMP) will review the data when they become available from ongoing studies. Once the CHMP decides that enough data is available, the company can make a formal application. By reviewing data availability, the CHMP can make an opinion about drug authorization earlier.