EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)
EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine HIPRA (also known as PHH-1V). This protein-based vaccine is being developed by HIPRA Human Health S.L.U. as a booster vaccine for adults who have already been fully vaccinated with a different COVID-19 vaccine.
The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies in adults. The clinical studies compared the immune response to the vaccine (measured by the level of antibodies against SARS-CoV-2) with that seen with the mRNA vaccine Comirnaty. Preliminary results suggest that the immune response with COVID-19 Vaccine HIPRA may be effective against SARS-CoV-2, including variants of concern such as Omicron.
EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.
The Agency will assess the compliance of COVID-19 Vaccine HIPRA with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate any eventual application because of the work done during the rolling review.
EMA will communicate further when the marketing authorisation application for the vaccine has been submitted.
How is the vaccine expected to work?
COVID-19 Vaccine HIPRA works by preparing the body to defend itself against COVID-19. It contains two versions of part of the spike protein (the receptor binding domain) which have been produced in the laboratory: one version corresponds to part of the spike protein of the alpha variant and the other corresponds to that of the beta variant. The spike protein is found on the surface of SARS-CoV-2 (the virus that causes COVID-19) and is used by the virus to enter the body’s cells. The vaccine also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.
When a person is given the vaccine, their immune system will identify the two proteins in the vaccine as foreign and produce natural defences — antibodies and T cells — against them. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.
COVID-19 Vaccine HIPRA is intended for use as a booster vaccine in people who have received a full primary vaccination course with an mRNA and/or an adenovirus COVID-19 vaccine.
What is a rolling review?
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 from ongoing studies. Once the CHMP decides that sufficient data are available, the company can submit a formal application. By reviewing the data as they become available, the CHMP can come to an opinion on the medicine’s authorisation sooner.
During a rolling review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force (COVID-ETF). This group brings together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of medicines and vaccines for COVID-19 and facilitate quick and coordinated regulatory action.